Non Serious Adverse Drug Reactions Report |
| Start Date:2016-09-21 End Date:2016-09-22 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:001 |
| Subject No :001-0019 | Subject Initials : | DOB :03/25/1988 | Sex:Female | Race:Caucasian | Height:170(cm) | Weight:58(kg) |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Visit 2 (Month 3) | 06/18/2015 | 9 | |
| Visit 5 (Month12)/Early Termination | | | |
| Visit 3 (Month 6) | 06/18/2015 | 9 | |
| Visit 1/ Baseline (Day 1) | 06/18/2015 | 9 | |
| Visit 4 (Month 9) | 06/18/2015 | 9 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| flu-like symptoms | 06/18/2015 | 09/04/2015 | | Suspected | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Concomitant medication | Resolved | | |
| Event description: |
| Subject received concomitant medications:Yes |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| Acetaminophen | 06/18/2015 | | 09/04/2015 | 500 | mg | occasionally |
| 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:2016-09-21 End Date:2016-09-22 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:002 |
| Subject No :002-0002 | Subject Initials : | DOB :08/13/1955 | Sex:Male | Race:Caucasian | Height:180(cm) | Weight:84(kg) |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Visit 2 (Month 3) | 02/16/2015 | 8 | |
| Visit 5 (Month12)/Early Termination | | | |
| Visit 3 (Month 6) | 02/16/2015 | 8 | |
| Visit 1/ Baseline (Day 1) | 02/16/2015 | 8 | |
| Visit 4 (Month 9) | 02/16/2015 | 8 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| Injection site inflammation | 11/11/2015 | 02/20/2016 | | Suspected | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Drug withdrawn | Led to study termination | Resolved | | |
| Event description: |
| Subject received concomitant medications |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Blood hypertension | | | Yes |
| Cardiac ischemic heart disease | | | Yes |
| Diabetes mellitus type 2 | | | Yes |
| Benign prostatic hyperplasia | | | Yes |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-09-21 End Date:2016-09-22 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:005 |
| Subject No :005-0001 | Subject Initials : | DOB :08/27/1996 | Sex:Female | Race:Caucasian | Height:169(cm) | Weight:65(kg) |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Visit 5 (Month12)/Early Termination | | | |
| Visit 1/ Baseline (Day 1) | 02/12/2015 | 5 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| local erythema and induration local site injection | 04/28/2015 | 05/30/2015 | | Suspected | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Drug withdrawn | Led to study termination | Resolved | | |
| Event description: |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| induration local site injection | 04/28/2015 | 05/30/2015 | | Suspected | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Drug withdrawn | Led to study termination | Resolved | | |
| Event description: |
| Subject received concomitant medications |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| 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:2016-09-21 End Date:2016-09-22 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:005 |
| Subject No :005-0007 | Subject Initials : | DOB :05/06/1966 | Sex:Female | Race:Caucasian | Height:165(cm) | Weight:70(kg) |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Visit 5 (Month12)/Early Termination | | | |
| Visit 1/ Baseline (Day 1) | 03/05/2015 | 9 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| local erythema at site injection | 04/10/2015 | 05/04/2015 | | Suspected | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Drug withdrawn | Led to study termination | Resolved | | |
| Event description: |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| induration local site injection | 03/25/2015 | 05/04/2015 | | Suspected | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Drug withdrawn | Led to study termination | Resolved | | |
| Event description: |
| Subject received concomitant medications |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| caesarean section | | | No |
| uterine fibromas | | | Yes |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-09-21 End Date:2016-09-22 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:005 |
| Subject No :005-0009 | Subject Initials : | DOB :04/22/1992 | Sex:Female | Race:Caucasian | Height:173(cm) | Weight:63(kg) |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Visit 5 (Month12)/Early Termination | | | |
| Visit 1/ Baseline (Day 1) | 03/26/2015 | 9 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| local erythema at site injection | 06/09/2015 | 07/15/2015 | | Suspected | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Drug withdrawn | Led to study termination | Resolved | | |
| Event description: |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| ecchymosis | 06/09/2015 | 07/15/2015 | | Suspected | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Drug withdrawn | Led to study termination | Resolved | | |
| Event description: |
| Subject received concomitant medications |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |