Non Serious Adverse Drug Reactions Report |
| Start Date:2016-06-07 End Date:2016-06-08 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:001 |
| Subject No :001-0003 | Subject Initials : | DOB :02/18/1975 | Sex:Male | Race:Caucasian | Height:175(cm) | Weight:80(kg) |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Visit 5 (Month12)/Early Termination | | | |
| Visit 2 (Month 3) | 12/19/2014 | 44 | |
| Visit 3 (Month 6) | 12/19/2014 | 44 | |
| Visit 1/ Baseline (Day 1) | 12/19/2014 | 44 | |
| Visit 4 (Month 9) | 12/19/2014 | 44 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| Flu-like Symptoms | 12/22/2014 | 12/23/2014 | | Suspected | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | None | 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:2016-06-07 End Date:2016-06-08 |
| 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 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 | 06/20/2015 | 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 | Yes | | 500 | mg | inconstancy |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |