Non Serious Adverse Drug Reactions Report |
| Start Date:2015-10-08 End Date:2015-10-12 |
| 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 | 112.5 | |
| 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:2015-10-08 End Date:2015-10-12 |
| 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:2015-10-08 End Date:2015-10-12 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0010 | Subject Initials :Y-H | DOB :10/18/1985 | Sex:Female | Race:Asian | Height:153cm | Weight:47.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/11/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/29/2015 | 06/02/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| Concomitant medication**(Othervalue:) | Not applicable | 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:2015-10-08 End Date:2015-10-12 |
| 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 risk | | | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | None | | | |
| 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 |
| Palace laparoscopy | Uk-Unk-2013 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2015-10-08 End Date:2015-10-12 |
| Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
| Subject No :C05-0001 | Subject Initials :XFZ | DOB :01/21/1988 | Sex:Female | Race:Asian | Height:159cm | Weight:50kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/01/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 08/16/2015 | 08/18/2015 | | Related | Severe |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Dose not changed | Concomitant medication ** | 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 |
| oophorocystectomy | UK-Jul-2013 | Not on treatment/medication | |
| salpingoplasty | UK-Feb-2014 | Not on treatment/medication | |
| salpingitis after previous tubal occlusion | UK-Feb-2014 | Not on treatment/medication | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2015-10-08 End Date:2015-10-12 |
| 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:74kg |
| 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 | 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:2015-10-08 End Date:2015-10-12 |
| 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:2015-10-08 End Date:2015-10-12 |
| 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:54kg |
| 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 | 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:2015-10-08 End Date:2015-10-12 |
| 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 |
Non Serious Adverse Drug Reactions Report |
| Start Date:2015-10-08 End Date:2015-10-12 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
| Subject No :k01-049 | Subject Initials :PGR | DOB :02/20/1983 | Sex:Female | Race:Asian | Height:168cm | Weight:62kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/02/2015 | 300 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/13/2015 | 05/29/2015 | | 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 | Concomitant medication **,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 |
| laparoscopic ovary cystectomy | UK-UNK-2004 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2015-10-08 End Date:2015-10-12 |
| 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:46kg |
| 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 | |