Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-20 End Date:2016-07-21 |
| 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:2016-07-20 End Date:2016-07-21 |
| 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:2016-07-20 End Date:2016-07-21 |
| 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 | 09/08/2015 | 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 | |