Non Serious Adverse Drug Reactions Report |
| Start Date:2015-08-24 End Date:2015-08-28 |
| 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:41.5kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/16/2015 | 113 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/06/2015 | 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 | Concomitant procedure** | 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 |
| Bilateral fallopian tube obstruction | 04/11/2014 | Not on treatment/medication | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2015-08-24 End Date:2015-08-28 |
| 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:43kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 06/26/2015 | 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: |
| 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:2015-08-24 End Date:2015-08-28 |
| 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:56kg |
| 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 | Led to study termination | 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:2015-08-24 End Date:2015-08-28 |
| 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:61kg |
| 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 | Led to study termination | 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 |