Non Serious Adverse Drug Reactions Report |
| Start Date:2016-06-14 End Date:2016-06-15 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:007 |
| Subject No :007-0009 | Subject Initials : | DOB :06/30/1965 | Sex:Male | Race:Caucasian | Height:183(cm) | Weight:79(kg) |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Visit 2 (Month 3) | 06/05/2015 | 9 | |
| Visit 5 (Month12)/Early Termination | | | |
| Visit 3 (Month 6) | 06/05/2015 | 9 | |
| Visit 1/ Baseline (Day 1) | 06/05/2015 | 9 | |
| Visit 4 (Month 9) | 06/05/2016 | 9 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| flu-like symptoms | 11/09/2015 | | | Suspected | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Dose not changed | Concomitant medication | Ongoing | | |
| Event description: |
| Subject received concomitant medications:Yes |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| Lioresal | 01/07/2015 | Yes | | 20 | mg | TID |
| Omnic Tocas | Uk-Unk-2014 | Yes | | 400 | mcg | QD |
| Ibuprofenum | 11/09/2015 | Yes | | 400 | mg | PRN |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| benign prostatic hyperplasia | | | Yes |
| congenital hydrocephalus | | | Yes |
| Depression | | | Yes |