Non Serious Adverse Drug Reactions Report |
| Start Date:2016-05-17 End Date:2016-05-18 |
| 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:2016-05-17 End Date:2016-05-18 |
| 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:2016-05-17 End Date:2016-05-18 |
| 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:2016-05-17 End Date:2016-05-18 |
| 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:2016-05-17 End Date:2016-05-18 |
| 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:2016-05-17 End Date:2016-05-18 |
| 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:2016-05-17 End Date:2016-05-18 |
| 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 | |