Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :Fei Gong | Country of Investigator :China | SiteNo:C01 |
| Subject No :C01-0001 | Subject Initials :TTW | DOB :05/13/1988 | Sex:Female | Race:Asian | Height:157cm | Weight:3050g |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/16/2015 | 112.5 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/06/2015 | 06/15/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Concomitant procedure** | Resolved | | |
| Event Description:Nausea, vomiting, yellow urine with less volume, chest pelvic effusion,ascites puncture 10-Jun-2015,2200ml;ascites puncture 15-Jun-2015,2900ml; |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Bilateral fallopian tube obstruction | 04/11/2014 | Not on treatment/medication | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :Fei Gong | Country of Investigator :China | SiteNo:C01 |
| Subject No :C01-0068 | Subject Initials :X-S | DOB :04/16/1989 | Sex:Female | Race:Asian | Height:160cm | Weight:2500g |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 06/27/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 07/23/2015 | 08/04/2015 | | Related | Severe |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Concomitant procedure** | Resolved | | |
| Event Description:Abdominal distension, Nausea, yellow urine with less volume, chest pelvic effusion，Ascites puncture 23Jul2015,1000ml; 27Jul2015,2100ml; 30Jul2015,2500ml; 04Aug2015,2000ml； |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| The left Hydrosalpinx and adhesions,less patency.Right fallopian tube partially blocked | 03/22/2014 | Not on treatment/medication | Ongoing |
| right fallopian tube resection because of Ectopic pregnancy | UK-Oct-2011 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :Fei Gong | Country of Investigator :China | SiteNo:C01 |
| Subject No :C01-0158 | Subject Initials :T-Y | DOB :06/17/1983 | Sex:Female | Race:Asian | Height:163cm | Weight:3300g |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/16/2015 | 112.5 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 10/11/2015 | 10/12/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Concomitant procedure** | Resolved | | |
| Event Description:Abdominal distension, Nausea, yellow urine with less volume, chest pelvic effusion,ascites puncture 12-Oct-2015,2500ml |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| right fallopian tube is less patency,left fallopian tube is obstruction | 06/04/2015 | Not on treatment/medication | Ongoing |
| Endometrial polyps hyperplasia | 08/24/2015 | Not on treatment/medication | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0002 | Subject Initials :LLL | DOB :02/12/1987 | Sex:Female | Race:Asian | Height:158cm | Weight:50.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/08/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/25/2015 | 06/03/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| salpingemphrxis,lalace peritoneoscope | Uk-Jul-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0008 | Subject Initials :R-H | DOB :02/06/1993 | Sex:Female | Race:Asian | Height:158cm | Weight:51.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/11/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/27/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| laparoscope hydrotubation | Uk-Unk-2013 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0010 | Subject Initials :Y-H | DOB :10/18/1985 | Sex:Female | Race:Asian | Height:153cm | Weight:47.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/11/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/29/2015 | 06/02/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0011 | Subject Initials :P-X | DOB :12/07/1994 | Sex:Female | Race:Asian | Height:160cm | Weight:60.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/11/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/27/2015 | 06/03/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| ectopic pregnancy Salping ectomy | Uk-Unk-2013 | On treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0023 | Subject Initials :JYF | DOB :11/10/1981 | Sex:Female | Race:Asian | Height:163cm | Weight:70.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/12/2015 | 300 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/30/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Hysteroscopy Salpingemphraxis | Uk-Mar-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0024 | Subject Initials :HXG | DOB :10/06/1992 | Sex:Female | Race:Asian | Height:150cm | Weight:55.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/12/2015 | 200 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/30/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0026 | Subject Initials :HCJ | DOB :07/07/1993 | Sex:Female | Race:Asian | Height:161cm | Weight:53.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/12/2015 | 200 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/30/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Laparotomy with left tubal ectopic pregnancy resection | Uk-Unk-2011 | Not on treatment/medication | |
| Under ectopic pregnancy laparoscopic conservative surgery | Uk-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0028 | Subject Initials :XHL | DOB :04/12/1981 | Sex:Female | Race:Asian | Height:158cm | Weight:65.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/12/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/25/2015 | 06/03/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Left abdominal ectopic pregnancy salpingectomy | Uk-Unk-2002 | Not on treatment/medication | |
| Right next laparoscopic tubal ectopic pregnancy surgery | Uk-Unk-2010 | Not on treatment/medication | |
| Conservative treatment of ectopic pregnancy | Uk-Unk-2004 | Not on treatment/medication | |
| Conservative treatment of ectopic pregnancy | Uk-Unk-2005 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0029 | Subject Initials :XLX | DOB :06/08/1981 | Sex:Female | Race:Asian | Height:158cm | Weight:70.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/12/2015 | 250 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/01/2015 | 06/07/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Pelvic mass laparoscopic pelvic surgery sticky points, bilateral tubal ostomy, left ovarian drilling, tubal. | Uk-Unk-2013 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0034 | Subject Initials :L-Z | DOB :09/04/1981 | Sex:Female | Race:Asian | Height:156cm | Weight:53.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/13/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/30/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0043 | Subject Initials :F-H | DOB :03/13/1983 | Sex:Female | Race:Asian | Height:164cm | Weight:54.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/13/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/30/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Laparoscopic tubal ectopic pregnancy at the right side of the window to take embryo | Uk-Unk-2005 | Not on treatment/medication | |
| Under the right fallopian tube ectopic pregnancy laparoscopic surgery | Uk-Unk-2007 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0045 | Subject Initials :H-T | DOB :09/08/1983 | Sex:Female | Race:Asian | Height:158cm | Weight:57.5kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/13/2015 | 250 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/28/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Hysteroscopic polypectomy | Uk-Aug-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0046 | Subject Initials :Q-H | DOB :10/07/1985 | Sex:Female | Race:Asian | Height:161cm | Weight:50.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/13/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/28/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0049 | Subject Initials :HPT | DOB :09/16/1980 | Sex:Female | Race:Asian | Height:155cm | Weight:50.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/14/2015 | 187.5 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/31/2015 | 06/03/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Laparoscopic surgery appendicitis | Uk-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0051 | Subject Initials :yqx | DOB :01/15/1983 | Sex:Female | Race:Asian | Height:154cm | Weight:50.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/14/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/31/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| salpingemphraxis,laparoscopic operation | Uk-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0052 | Subject Initials :YLL | DOB :02/07/1992 | Sex:Female | Race:Asian | Height:165cm | Weight:54.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/14/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/30/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0053 | Subject Initials :YND | DOB :04/13/1992 | Sex:Female | Race:Asian | Height:155cm | Weight:45.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/14/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/30/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Laparoscopic tubal colostomy, pelvic surgery sticky points. | Uk-Unk-2013 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0059 | Subject Initials :J-L | DOB :12/23/1984 | Sex:Female | Race:Asian | Height:155cm | Weight:50.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/14/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/31/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0060 | Subject Initials :Y-W | DOB :11/10/1981 | Sex:Female | Race:Asian | Height:150cm | Weight:45.5kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/14/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/27/2015 | 06/03/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Laparoscopic pelvic sticking points, ovarian drilling, tubal surgery to clear. | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0061 | Subject Initials :T-D | DOB :02/15/1988 | Sex:Female | Race:Asian | Height:161cm | Weight:60.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/14/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/28/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| salpingemphraxis,laparoscopic operation | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0062 | Subject Initials :FQR | DOB :07/25/1983 | Sex:Female | Race:Asian | Height:162cm | Weight:46.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/14/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/30/2015 | 06/03/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Hysteroscopic tubal inspection | Uk-May-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0063 | Subject Initials :HMC | DOB :07/25/1981 | Sex:Female | Race:Asian | Height:162cm | Weight:50.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/15/2015 | 250 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/29/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Hysteroscopic surgery through liquid | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0070 | Subject Initials :ZQC | DOB :02/08/1977 | Sex:Female | Race:Asian | Height:164cm | Weight:67.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/15/2015 | 200 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/28/2015 | 06/03/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0071 | Subject Initials :LLX | DOB :07/13/1987 | Sex:Female | Race:Asian | Height:157cm | Weight:41.5kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/15/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/31/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Laparoscopic pelvic sub sticky, sticky points left fallopian tube surgery. | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0076 | Subject Initials :F-L | DOB :05/15/1987 | Sex:Female | Race:Asian | Height:150cm | Weight:51.5kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/15/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/27/2015 | 06/03/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Sticky points lower pelvic laparoscopy surgery, tubal surgery. | Uk-Unk-2012 | Not on treatment/medication | |
| Hysteroscopic tubal surgery | Uk-Sep-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0082 | Subject Initials :Y-L | DOB :09/04/1986 | Sex:Female | Race:Asian | Height:162cm | Weight:59.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/18/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/30/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0083 | Subject Initials :Y-L | DOB :08/20/1988 | Sex:Female | Race:Asian | Height:158cm | Weight:54.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/18/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/31/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Laparoscopic pelvic sticky points left salpingostomy | Uk-Unk-2013 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0086 | Subject Initials :YZZ | DOB :07/07/1987 | Sex:Female | Race:Asian | Height:150cm | Weight:55.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/18/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/01/2015 | 06/12/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0087 | Subject Initials :XPT | DOB :06/15/1988 | Sex:Female | Race:Asian | Height:158cm | Weight:57.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | | | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/30/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Hysteroscopy normal | Uk-Mar-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0088 | Subject Initials :HLK | DOB :06/14/1986 | Sex:Female | Race:Asian | Height:159cm | Weight:59.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/18/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/30/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Palace laparoscopic pelvic surgery sticky points, bilateral tubal plastic surgery, endometriosis lesions fulguration. | Uk-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0089 | Subject Initials :XYZ | DOB :06/12/1986 | Sex:Female | Race:Asian | Height:152cm | Weight:48.5kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/18/2015 | 187.5 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/04/2015 | 06/12/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Sticky points pelvic laparoscopy surgery, tubal surgery to clear | Uk-Nov-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0095 | Subject Initials :MLG | DOB :08/19/1990 | Sex:Female | Race:Asian | Height:155cm | Weight:54.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/19/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/31/2015 | 06/05/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0102 | Subject Initials :HYD | DOB :10/14/1985 | Sex:Female | Race:Asian | Height:163cm | Weight:57.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/19/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/01/2015 | 06/12/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Palace laparoscopy | Uk-Unk-2013 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0103 | Subject Initials :CPZ | DOB :05/12/1989 | Sex:Female | Race:Asian | Height:165cm | Weight:63.5kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/19/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/02/2015 | 06/12/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| The right side of the open line on the right side of salpingectomy tubal pregnancy | Uk-Unk-2011 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0111 | Subject Initials :CXW | DOB :10/10/1979 | Sex:Female | Race:Asian | Height:162cm | Weight:68.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/20/2015 | 200 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/02/2015 | 06/12/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Ectopic pregnancy laparoscopic surgery, the left fallopian tube embryo window. | Uk-Unk-2012 | Not on treatment/medication | |
| Tubal lipiodol angiography | Uk-Unk-2013 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0115 | Subject Initials :KJT | DOB :07/02/1988 | Sex:Female | Race:Asian | Height:163cm | Weight:52.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/21/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/05/2015 | 06/12/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG examination: bilateral tubal occlusion | Uk-Unk-2012 | Not on treatment/medication | |
| Laparoscopy surgery: pelvic sticky points, bilateral tubal ostomy + right side mesosalpinx cyst removal. | Uk-May-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0118 | Subject Initials :MLF | DOB :08/03/1984 | Sex:Female | Race:Asian | Height:160cm | Weight:55.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/21/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/07/2015 | 06/12/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal obstruction | Uk-Unk-2007 | Not on treatment/medication | |
| Laparoscopic pelvic sticky points, bilateral ovarian drilling | Uk-Unk-2007 | Not on treatment/medication | |
| Cervical biopsy showing inflammation | Uk-Unk-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0124 | Subject Initials :Y-C | DOB :07/17/1982 | Sex:Female | Race:Asian | Height:150cm | Weight:48.5kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/21/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/07/2015 | 06/12/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: the left fallopian tube obstruction and hydrocephalus right salpingitis | Uk-Unk-2013 | Not on treatment/medication | |
| Hysteroscopy normal | Uk-Mar-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0126 | Subject Initials :RCM | DOB :01/09/1989 | Sex:Female | Race:Asian | Height:165cm | Weight:60.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/21/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/07/2015 | 06/12/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: the right fallopian tube obstruction, poor uterine shape | Uk-Unk-2013 | Not on treatment/medication | |
| Hysteroscopy: uterine spindle-shaped, single horn. | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0134 | Subject Initials :QYL | DOB :06/17/1986 | Sex:Female | Race:Asian | Height:155cm | Weight:47.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/22/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/06/2015 | 06/12/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Laparotomy: pelvic abscess incision and drainage, the right accessories cystectomy | Uk-Unk-2009 | Not on treatment/medication | |
| Hysteroscopy normal uterine shape | Uk-Unk-2013 | Not on treatment/medication | |
| Hysteroscopic curettage | Uk-Unk-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0136 | Subject Initials :Q-L | DOB :03/28/1984 | Sex:Female | Race:Asian | Height:154cm | Weight:47.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/22/2015 | 200 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/08/2015 | 06/12/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal obstruction incomplete | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0137 | Subject Initials :YLF | DOB :11/01/1989 | Sex:Female | Race:Asian | Height:153cm | Weight:47.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/22/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/09/2015 | 06/16/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal obstruction | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0138 | Subject Initials :TTJ | DOB :06/20/1990 | Sex:Female | Race:Asian | Height:150cm | Weight:41.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/22/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/06/2015 | 06/12/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Ectopic pregnancy laparoscopic surgery: the right fallopian tube embryo pelvic sticking points | Uk-Jan-2014 | Not on treatment/medication | |
| Hysteroscopy: endometrial polyps. | Uk-Feb-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0142 | Subject Initials :HMT | DOB :02/19/1988 | Sex:Female | Race:Asian | Height:168cm | Weight:46.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/22/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/07/2015 | 06/12/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal obstruction and hydrocephalus | Uk-Unk-2014 | Not on treatment/medication | |
| Laparoscopy surgery: pelvic stars stick + fulguration of endometriosis foci, tubal plastic surgery | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0143 | Subject Initials :F-L | DOB :11/06/1982 | Sex:Female | Race:Asian | Height:155cm | Weight:51.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/22/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/08/2015 | 06/14/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: the left fallopian tube obstruction, incomplete right fallopian tube obstruction | Uk-Unk-2012 | Not on treatment/medication | |
| Laparoscopy surgery: pelvic stars stick + tubal surgery, endometriosis lesions fulguration | Uk-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0153 | Subject Initials :H-H | DOB :07/12/1979 | Sex:Female | Race:Asian | Height:153cm | Weight:43.5kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/25/2015 | 250 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/10/2015 | 06/16/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0157 | Subject Initials :Y-Z | DOB :07/22/1984 | Sex:Female | Race:Asian | Height:156cm | Weight:55.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/25/2015 | 200 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/10/2015 | 06/16/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal obstruction | Uk-Unk-2006 | Not on treatment/medication | |
| Laparoscopic Surgery: Tubal clear. | Uk-Unk-2007 | Not on treatment/medication | |
| Ectopic pregnancy laparoscopic surgery: tubal embryo window. | Uk-Jan-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0161 | Subject Initials :H-Y | DOB :12/12/1985 | Sex:Female | Race:Asian | Height:166cm | Weight:57.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/26/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/10/2015 | 06/16/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal obstruction | Uk-Unk-2007 | Not on treatment/medication | |
| Laparoscopic tubal surgery sticking points. | Uk-Unk-2007 | Not on treatment/medication | |
| Open left fallopian tube ectopic pregnancy surgery | Uk-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0164 | Subject Initials :AHC | DOB :12/12/1982 | Sex:Female | Race:Asian | Height:156cm | Weight:49.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/26/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/12/2015 | 06/20/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal occlusion side | Uk-Unk-2012 | Not on treatment/medication | |
| Laparoscopy Surgery: salpingostomy, pelvic adhesions dissection. | Uk-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0169 | Subject Initials :L-W | DOB :06/08/1985 | Sex:Female | Race:Asian | Height:166cm | Weight:50.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/27/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/12/2015 | 06/20/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | None | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal occlusion insufficiency | Uk-Jun-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0174 | Subject Initials :YXC | DOB :06/04/1982 | Sex:Female | Race:Asian | Height:155cm | Weight:54.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/27/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/12/2015 | 06/16/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Laparoscopic surgery: left ovarian endometriosis cystectomy | Uk-Unk-2010 | Not on treatment/medication | |
| HSG: the left fallopian tube obstruction, right fallopian tube inflammation. | Uk-Unk-2012 | Not on treatment/medication | |
| Laparoscopic surgery: pelvic adhesions dissection, left fallopian tube plastic surgery | Uk-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0175 | Subject Initials :L-T | DOB :02/15/1989 | Sex:Female | Race:Asian | Height:158cm | Weight:40.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/27/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/11/2015 | 06/16/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal obstruction. | Uk-Aug-2014 | Not on treatment/medication | |
| Laparoscopy surgery: pelvic adhesions dissection, tubal plastic surgery to repair the left corpus luteum cyst cystectomy, | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0178 | Subject Initials :XSC | DOB :10/11/1988 | Sex:Female | Race:Asian | Height:155cm | Weight:54.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/27/2015 | 200 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/10/2015 | 06/16/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal resistance. | Uk-Jan-2013 | Not on treatment/medication | |
| Laparoscopy surgery: pelvic adhesions dissection, bilateral salpingo-repair plastic surgery, normal uterine shape. | Uk-Jan-2013 | Not on treatment/medication | |
| Hysteroscopy normal, water surgery: incomplete right fallopian tube obstruction | Uk-Feb-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0179 | Subject Initials :HYZ | DOB :05/14/1991 | Sex:Female | Race:Asian | Height:158cm | Weight:53.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/27/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/11/2015 | 06/16/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Ectopic pregnancy laparotomy: the left fallopian tube removal. | Uk-Unk-2009 | Not on treatment/medication | |
| Abdominal ectopic pregnancy conservative surgery. | Uk-Unk-2010 | Not on treatment/medication | |
| Hysteroscopy: endometrial polyp excision. | Uk-Jan-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0180 | Subject Initials :YPW | DOB :08/20/1982 | Sex:Female | Race:Asian | Height:156cm | Weight:57.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/27/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/13/2015 | 06/16/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Ectopic pregnancy: treatment of chemical drugs to kill embryos | Uk-Unk-2012 | Not on treatment/medication | |
| HSG: bilateral tubal occlusion | Uk-Unk-2008 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0185 | Subject Initials :YMX | DOB :09/07/1975 | Sex:Female | Race:Asian | Height:159cm | Weight:63.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/28/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/15/2015 | 06/20/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal occlusion | Uk-Unk-2013 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0190 | Subject Initials :F-H | DOB :03/09/1984 | Sex:Female | Race:Asian | Height:160cm | Weight:55.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/28/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/12/2015 | 06/16/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0191 | Subject Initials :SYZ | DOB :02/16/1983 | Sex:Female | Race:Asian | Height:162cm | Weight:58.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/28/2015 | 200 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/14/2015 | 06/18/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal occlusion with effusion | Uk-Unk-2008 | Not on treatment/medication | |
| Tubal treatment: Tips patency | Uk-Unk-2008 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0195 | Subject Initials :J-L | DOB :08/15/1984 | Sex:Female | Race:Asian | Height:156cm | Weight:48.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/28/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/14/2015 | 06/18/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal patency, pelvic adhesions. | Uk-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0200 | Subject Initials :L-Z | DOB :12/17/1988 | Sex:Female | Race:Asian | Height:155cm | Weight:70.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/28/2015 | 187.5 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/13/2015 | 06/18/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral obstruction | Uk-Apr-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0201 | Subject Initials :J-L | DOB :12/15/1990 | Sex:Female | Race:Asian | Height:168cm | Weight:65kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/07/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/26/2015 | 10/02/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal occlusion | Uk-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0202 | Subject Initials :F-Q | DOB :06/09/1985 | Sex:Female | Race:Asian | Height:159cm | Weight:65.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/27/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/11/2015 | 09/16/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal patency | Uk-Unk-2013 | Not on treatment/medication | |
| Laparoscopic surgery: pelvic adhesions dissection, bilateral mesosalpinx cystectomy | Uk-Unk-2014 | Not on treatment/medication | |
| Tubal examination: smooth | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0206 | Subject Initials :YPZ | DOB :10/20/1980 | Sex:Female | Race:Asian | Height:150cm | Weight:47.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/28/2015 | 187.5 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/14/2015 | 09/18/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal occlusion | Uk-Unk-2011 | Not on treatment/medication | |
| Laparoscopy surgery: pelvic adhesions dissection, bilateral tubal surgery to clear. | Uk-Unk-2011 | Not on treatment/medication | |
| HSG: bilateral tubal occlusion | Uk-Unk-2013 | Not on treatment/medication | |
| Laparoscopy surgery: pelvic adhesions dissection, uterine fibroids dug surgery, tubal surgery to clear, coherent liquid skill. | Uk-Unk-2013 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0207 | Subject Initials :JHZ | DOB :09/03/1984 | Sex:Female | Race:Asian | Height:160cm | Weight:55.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/28/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/13/2015 | 09/18/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Ectopic pregnancy laparoscopic surgery: Left salpingectomy | Uk-Unk-2011 | Not on treatment/medication | |
| Ectopic pregnancy laparoscopic surgery: Right salpingectomy | Uk-Unk-2013 | Not on treatment/medication | |
| HSG: bilateral tubal occlusion | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0208 | Subject Initials :MQW | DOB :09/24/1988 | Sex:Female | Race:Asian | Height:156cm | Weight:54.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/28/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/14/2015 | 09/18/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Hysteroscopic resection of endometrial polyps | Uk-Unk-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0210 | Subject Initials :GLW | DOB :05/08/1983 | Sex:Female | Race:Asian | Height:160cm | Weight:55.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/28/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/15/2015 | 09/20/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: the right fallopian tube obstruction | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0215 | Subject Initials :L-X | DOB :08/05/1989 | Sex:Female | Race:Asian | Height:165cm | Weight:56.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/28/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/14/2015 | 09/18/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal occlusion | Uk-Unk-2014 | Not on treatment/medication | |
| Under laparoscopy surgery to clear the fallopian tubes, pelvic adhesions dissection | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0217 | Subject Initials :YQX | DOB :02/10/1987 | Sex:Female | Race:Asian | Height:157cm | Weight:60.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/31/2015 | 187.5 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/15/2015 | 09/20/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Ectopic pregnancy therapy chemotherapy to kill embryos | Uk-Unk-2011 | Not on treatment/medication | |
| HSG: bilateral tubal obstruction. | Uk-Unk-2010 | Not on treatment/medication | |
| Laparoscopy surgery: pelvic adhesions dissection, bilateral tubal surgery to clear | Uk-Unk-2010 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0219 | Subject Initials :YLZ | DOB :06/17/1986 | Sex:Female | Race:Asian | Height:160cm | Weight:46.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/31/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/15/2015 | 09/20/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal obstruction. | Uk-Unk-2011 | Not on treatment/medication | |
| HSG: bilateral tubal patency, pelvic adhesions. | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0220 | Subject Initials :CCT | DOB :05/15/1985 | Sex:Female | Race:Asian | Height:152cm | Weight:51.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/31/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/15/2015 | 09/20/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal patency. | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0222 | Subject Initials :YMD | DOB :04/19/1983 | Sex:Female | Race:Asian | Height:158cm | Weight:42.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/31/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/16/2015 | 09/20/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: the side of tubal passable. | Uk-Unk-2012 | Not on treatment/medication | |
| Laparoscopic surgery: bilateral tubal surgery, right fallopian tube patency. | Uk-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0224 | Subject Initials :JXL | DOB :11/11/1985 | Sex:Female | Race:Asian | Height:158cm | Weight:52.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/01/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/19/2015 | 09/25/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal occlusion in the left effusion | Uk-Unk-2014 | Not on treatment/medication | |
| Laparoscopic pelvic adhesions dissection and bilateral tubal fluid plastic ostomy, hysteroscopic resection of endometrial polyps palace | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0226 | Subject Initials :BQX | DOB :07/10/1987 | Sex:Female | Race:Asian | Height:160cm | Weight:53.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/01/2015 | 187.5 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/17/2015 | 09/22/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Laparoscopic surgery classification pelvic adhesions, tubal fluid prosthetics | Uk-Unk-2010 | Not on treatment/medication | |
| Laparoscopic surgery classification pelvic adhesions, tubal fluid prosthetics | Uk-Unk-2011 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0227 | Subject Initials :YXZ | DOB :12/09/1985 | Sex:Female | Race:Asian | Height:164cm | Weight:56.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/01/2015 | 187.5 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/17/2015 | 09/22/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Abdominal ectopic pregnancy conservative surgery. | Uk-Unk-2012 | Not on treatment/medication | |
| Ectopic pregnancy laparoscopic conservative surgery. | Uk-Unk-2013 | Not on treatment/medication | |
| HSG: incomplete right fallopian tube obstruction, left fallopian tube fluid. | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0228 | Subject Initials :J-X | DOB :09/12/1981 | Sex:Female | Race:Asian | Height:160cm | Weight:51.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/02/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/20/2015 | 09/25/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: right fallopian tube obstruction. | Uk-Unk-2013 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0229 | Subject Initials :HYT | DOB :11/13/1992 | Sex:Female | Race:Asian | Height:153cm | Weight:45.5kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/02/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/18/2015 | 09/24/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal occlusion | Uk-Unk-2013 | Not on treatment/medication | |
| Laparoscopic surgery: pelvic adhesions dissection, tubal plasty, uterine fibroids dug surgery, uterine suspension surgery. | Uk-Unk-2013 | Not on treatment/medication | |
| Hysteroscopy normal | Uk-Unk-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0230 | Subject Initials :F-X | DOB :07/08/1987 | Sex:Female | Race:Asian | Height:156cm | Weight:51.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/02/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/18/2015 | 09/24/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Caesarean section | Uk-Unk-2009 | Not on treatment/medication | |
| HSG: bilateral tubal occlusion | Uk-Mar-2015 | Not on treatment/medication | |
| Hysteroscopy normal | Uk-Unk-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0231 | Subject Initials :LJS | DOB :08/28/1981 | Sex:Female | Race:Asian | Height:160cm | Weight:69.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/02/2015 | 300 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/17/2015 | 09/24/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: the left fallopian tube passable | Uk-Unk-2013 | Not on treatment/medication | |
| Palace laparoscopy | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0239 | Subject Initials :JJL | DOB :01/25/1984 | Sex:Female | Race:Asian | Height:158cm | Weight:49.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/06/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/23/2015 | 09/27/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: incomplete right fallopian tube obstruction, left fallopian tube obstruction | Uk-Mar-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0240 | Subject Initials :DMX | DOB :01/01/1985 | Sex:Female | Race:Asian | Height:155cm | Weight:47.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/06/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/21/2015 | 09/26/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Laparoscopy surgery: pelvic adhesions separation surgery, plastic surgery to repair the fallopian tubes, uterine cavity is normal. | Uk-Unk-2013 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0244 | Subject Initials :DDW | DOB :09/13/1986 | Sex:Female | Race:Asian | Height:160cm | Weight:53.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/06/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/22/2015 | 09/27/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: bilateral tubal patency | Uk-Unk-2008 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0247 | Subject Initials :BSH | DOB :08/12/1987 | Sex:Female | Race:Asian | Height:155cm | Weight:40.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/07/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/23/2015 | 09/27/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: the right fallopian tube obstruction, incomplete left fallopian tube obstruction | Uk-Mar-2014 | Not on treatment/medication | |
| Laparoscopy surgery: dissection of pelvic adhesions, tubal repair plastic surgery, and it was surgery. | Uk-Apr-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0249 | Subject Initials :ZPY | DOB :09/13/1982 | Sex:Female | Race:Asian | Height:162cm | Weight:55.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/07/2015 | 187.5 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/22/2015 | 09/28/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| HSG: incomplete right fallopian tube obstruction, left fallopian tube obstruction | Uk-Unk-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C04 |
| Subject No :C04-0087 | Subject Initials :HZD | DOB :08/04/1983 | Sex:Female | Race:Asian | Height:161cm | Weight:60kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 06/26/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 07/07/2015 | 07/21/2015 | | Related | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Dose reduced | None | Resolved | | |
| Event Description:none |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| spontaneous abortion | 01/05/2010 | Not on treatment/medication | |
| spontaneous abortion | 05/18/2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C04 |
| Subject No :C04-0127 | Subject Initials :LQT | DOB :06/28/1993 | Sex:Female | Race:Asian | Height:156cm | Weight:50g |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | | | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| spontaneous abotion | 10/28/2015 | 10/28/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Concomitant procedure** | Resolved | | |
| Event Description: |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C04 |
| Subject No :C04-0171 | Subject Initials :SHL | DOB :08/17/1987 | Sex:Female | Race:Asian | Height:154cm | Weight:40kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/29/2015 | 300 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/30/2015 | 10/09/2015 | | Related | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Dose reduced | None | Resolved | | |
| Event Description:none |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
| Subject No :C05-0001 | Subject Initials :XFZ | DOB :01/21/1988 | Sex:Female | Race:Asian | Height:159cm | Weight:50kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/01/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 08/16/2015 | 08/18/2015 | | Related | Severe |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | None | Resolved | | |
| Event Description:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml，ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| oophorocystectomy | UK-Jul-2013 | Not on treatment/medication | |
| salpingoplasty | UK-Feb-2014 | Not on treatment/medication | |
| salpingitis after previous tubal occlusion | UK-Feb-2014 | Not on treatment/medication | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
| Subject No :C05-0010 | Subject Initials :Q-Z | DOB :01/31/1990 | Sex:Female | Race:Asian | Height:159cm | Weight:45kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/02/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 08/17/2015 | 08/24/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| Disease under study**,Protocol procedure**,Concomitant medication**(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
| Event Description:abdominal distention;nausea Drug：Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml，ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 17-Aug-2015 / 27-Aug-2015 |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
| Subject No :C05-0013 | Subject Initials :L-L | DOB :06/12/1986 | Sex:Female | Race:Asian | Height:159cm | Weight:54.5kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/02/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 08/18/2015 | 08/20/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| Disease under study**,Protocol procedure**,Concomitant medication**(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
| Event Description:abdominal distention;nausea ,ascites,Drug：Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml，ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 18-Aug-2015 / 20-Aug-2015 |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| ampullary pregnancy | UK-Unk-2010 | Not on treatment/medication | |
| ampullary pregnancy | UK-Unk-2012 | Not on treatment/medication | |
| ampullary pregnancy | UK-Unk-2013 | Not on treatment/medication | |
| salpingocatheterism | UK-Unk-2013 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
| Subject No :C05-0021 | Subject Initials :FYZ | DOB :08/28/1990 | Sex:Female | Race:Asian | Height:150cm | Weight:45kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/04/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 08/19/2015 | 08/21/2015 | | Related | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| Protocol procedure**,Concomitant medication**(Othervalue:) | Not applicable | None | Resolved | | |
| Event Description:abdominal distention;Drug：Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml，ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 19-Aug-2015 / 21-Aug-2015 |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| salpingocatheterism | UK-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
| Subject No :C05-0041 | Subject Initials :W-Y | DOB :07/03/1981 | Sex:Female | Race:Asian | Height:153cm | Weight:55kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/08/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 08/23/2015 | 08/25/2015 | | Related | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| Protocol procedure**,Concomitant medication**(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
| Event Description:abdominal distention;Drug：Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml，ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 21-Aug-2015 / 25-Aug-2015 |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
| Subject No :C05-0056 | Subject Initials :X-P | DOB :06/14/1983 | Sex:Female | Race:Asian | Height:158cm | Weight:46kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/13/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 08/27/2015 | 08/29/2015 | | Related | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| Protocol procedure**,Concomitant medication**(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
| Event Description:abdominal distention;nausea ;ascites;Drug：Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml，ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 17-Aug-2015 / 27-Aug-2015 |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
| Subject No :C05-0068 | Subject Initials :YPL | DOB :12/07/1985 | Sex:Female | Race:Asian | Height:160cm | Weight:50kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/15/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 08/27/2015 | 08/29/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| Protocol procedure**,Concomitant medication**(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
| Event Description:abdominal distention;nausea ;ascites;Drug：Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml，ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 17-Aug-2015 / 27-Aug-2015 |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Fallopian tube repair anaplasty | UK-Unk-2010 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
| Subject No :C05-0117 | Subject Initials :Y-L | DOB :04/16/1982 | Sex:Female | Race:Asian | Height:165cm | Weight:48kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/23/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/08/2015 | 09/10/2015 | | Related | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| Protocol procedure**,Concomitant medication**(Othervalue:) | Dose reduced | Led to study termination | Resolved | | |
| Event Description:abdominal distention;ascites;Drug：Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml，ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 19-Aug-2015 / 21-Aug-2015 |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
| Subject No :C05-0132 | Subject Initials :HQL | DOB :07/16/1980 | Sex:Female | Race:Asian | Height:166cm | Weight:57kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/27/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/09/2015 | 09/16/2015 | | Related | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| Disease under study**(Othervalue:) | Dose not changed | None | Resolved | | |
| Event Description: |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Fallopian tube repair anaplasty | UK-Unk-2011 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
| Subject No :C05-0141 | Subject Initials :XHZ | DOB :04/14/1987 | Sex:Female | Race:Asian | Height:158cm | Weight:48kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/29/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/12/2015 | 09/14/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| Protocol procedure**,Concomitant medication**(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
| Event Description:abdominal distention;nausea ;ascites;Drug：Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml，ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 17-Aug-2015 / 27-Aug-2015 |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Fallopian tube repair anaplasty | UK-Unk-2009 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
| Subject No :k01-0059 | Subject Initials :LKH | DOB :08/05/1981 | Sex:Female | Race:Asian | Height:153cm | Weight:74g |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 06/02/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/13/2015 | 07/02/2015 | | Related | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Dose not changed | None | Resolved | | |
| Event Description: |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
| Subject No :k01-035 | Subject Initials :PSS | DOB :01/19/1983 | Sex:Female | Race:Asian | Height:161cm | Weight:56g |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 03/11/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 03/23/2015 | 04/21/2015 | | Related | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Dose not changed | None | Resolved | | |
| Event Description: no addtional data |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
| Subject No :k01-036 | Subject Initials :JSY | DOB :07/28/1981 | Sex:Female | Race:Asian | Height:162cm | Weight:54g |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 03/13/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 03/24/2015 | 04/07/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Dose not changed | None | Resolved | | |
| Event Description: |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
| Subject No :k01-040 | Subject Initials :LBH | DOB :03/05/1985 | Sex:Female | Race:Asian | Height:164cm | Weight:61g |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 04/06/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 04/15/2015 | 04/30/2015 | | Related | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Dose not changed | None | Resolved | | |
| Event Description: |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
| Subject No :k01-049 | Subject Initials :PGR | DOB :02/20/1983 | Sex:Female | Race:Asian | Height:168cm | Weight:62g |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/02/2015 | 300 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/13/2015 | 05/29/2015 | | Related | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Concomitant medication **,Led to study termination | Resolved | | |
| Event Description:albumin treatment and resloved |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| laparoscopic ovary cystectomy | UK-UNK-2004 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-15 End Date:2016-07-18 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
| Subject No :k01-050 | Subject Initials :KHG | DOB :04/22/1984 | Sex:Female | Race:Asian | Height:150cm | Weight:46g |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/03/2015 | 300 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/14/2015 | 05/29/2015 | | Related | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
| Event Description: |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| ovary cystectomy | UK-Jan-2014 | Not on treatment/medication | |