Non Serious Adverse Drug Reactions Report |
| Start Date:2016-09-19 End Date:2016-09-20 |
| 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 | | | 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| None(Othervalue:) | Drug withdrawn | Led to study termination | Ongoing | | |
| 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 | | | 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| None(Othervalue:) | Drug withdrawn | Led to study termination | Ongoing | | |
| 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:2016-09-19 End Date:2016-09-20 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:006 |
| Subject No :006-0005 | Subject Initials : | DOB :08/28/1965 | 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 2 (Month 3) | 03/11/2015 | 8 | |
| Visit 5 (Month12)/Early Termination | | | |
| Visit 3 (Month 6) | 03/11/2015 | 8 | |
| Visit 1/ Baseline (Day 1) | 03/11/2015 | 8 | |
| Visit 4 (Month 9) | 03/11/2015 | 8 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| increased liver enzimes | 06/11/2015 | 12/19/2015 | | Suspected | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Dose not changed | None | Resolved with sequelae | | |
| Event description: |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| necrosis at injection site | 06/30/2015 | 09/09/2015 | | Suspected | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| Protocol procedure(Othervalue:) | Not applicable | None | Resolved | | |
| Event description: |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| increased liver enzymes | 12/20/2015 | | | Suspected | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | None | Ongoing | | |
| Event description: |
| Subject received concomitant medications:Yes |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| desloratadinum | 08/22/2015 | | 09/09/2015 | 5 | miligrams | qd |
| liv 52 | 08/22/2015 | Yes | | 275 | miligrams | qd |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| thrombophilia | | | Yes |
| arterial hipertension | | | Yes |
| peripheral artheriopathy | | | Yes |