Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-13 End Date:2016-04-14 |
| 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:2016-04-13 End Date:2016-04-14 |
| 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:2016-04-13 End Date:2016-04-14 |
| 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:2016-04-13 End Date:2016-04-14 |
| 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 | |
| |