Non Serious Adverse Drug Reactions Report |
| Start Date:2016-08-29 End Date:2016-08-30 |
| 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 | | | 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| None(Othervalue:) | Drug withdrawn | Led to study termination | Ongoing | | |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 | 04/28/2015 | | | 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| None(Othervalue:) | Drug withdrawn | Led to study termination | Ongoing | | |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:No |
| Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-08-29 End Date:2016-08-30 |
| 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, pain | 06/09/2015 | | | 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 |
| ecchymosis | 06/09/2015 | | | 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:No |
| Condition | Start Date | Related to study condition | Ongoing |