Non Serious Adverse Drug Reactions Report |
| Start Date:2016-03-18 End Date:2016-03-21 |
| 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 | | | 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| None(Othervalue:) | Drug withdrawn | Led to study termination | Ongoing | | |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 |
| Blood hypertension | | | Yes |
| Cardiac ischemic heart disease | | | Yes |
| Diabetes mellitus type 2 | | | Yes |
| Benign prostatic hyperplasia | | | Yes |