Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-25 End Date:2016-04-26 |
| 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:2016-04-25 End Date:2016-04-26 |
| 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:2016-04-25 End Date:2016-04-26 |
| 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:2016-04-25 End Date:2016-04-26 |
| 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:2016-04-25 End Date:2016-04-26 |
| 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:2016-04-25 End Date:2016-04-26 |
| 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:2016-04-25 End Date:2016-04-26 |
| 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:2016-04-25 End Date:2016-04-26 |
| 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:2016-04-25 End Date:2016-04-26 |
| 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 | |