Non Serious Adverse Drug Reactions Report |
| Start Date:2016-08-09 End Date:2016-08-10 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:006 |
| Subject No :006-0003 | Subject Initials : | DOB :07/16/1984 | Sex:Male | Race:Caucasian | Height:182(cm) | Weight:63(kg) |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Visit 2 (Month 3) | 03/05/2015 | 8 | |
| Visit 5 (Month12)/Early Termination | | | |
| Visit 3 (Month 6) | 03/11/2015 | 8 | |
| Visit 1/ Baseline (Day 1) | 03/06/2015 | 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 enzymes | 09/12/2015 | 11/14/2015 | | 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 procedure | Resolved | | |
| Event description: |
| Subject received concomitant medications:Yes |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| tolperison | 05/01/2015 | | 05/31/2015 | 450 | miligrams | qd |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| chronic sinusitis | | | Yes |
| pituitary microadenoma | | | Yes |