Non Serious Adverse Drug Reactions Report |
| Start Date:2016-08-03 End Date:2016-08-04 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:007 |
| Subject No :007-0003 | Subject Initials : | DOB :04/19/1977 | Sex:Female | Race:Caucasian | Height:173(cm) | Weight:60(kg) |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Visit 2 (Month 3) | 05/04/2015 | 9 | |
| Visit 5 (Month12)/Early Termination | | | |
| Visit 3 (Month 6) | 05/04/2015 | 9 | |
| Visit 1/ Baseline (Day 1) | 05/04/2015 | 9 | |
| Visit 4 (Month 9) | 05/04/2015 | 9 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| elevated liver enzymes | 05/30/2015 | 10/31/2015 | | Suspected | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| Concomitant medication(Othervalue:) | Not applicable | Concomitant medication | Resolved | | |
| Event description: |
| Subject received concomitant medications:Yes |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| Paracetamol | 05/04/2015 | | 07/17/2015 | 500 | mg | PRN |
| LIV 52 | 05/30/2015 | | 07/19/2015 | 3 | tb | TID |
| LIV 52 | 07/20/2015 | | 12/12/2015 | 6 | tb | TID |
| 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:2016-08-03 End Date:2016-08-04 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:007 |
| Subject No :007-0006 | Subject Initials : | DOB :05/09/1987 | Sex:Male | Race:Caucasian | Height:175(cm) | Weight:70(kg) |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Visit 2 (Month 3) | 05/15/2015 | 9 | |
| Visit 5 (Month12)/Early Termination | | | |
| Visit 1/ Baseline (Day 1) | 05/15/2015 | 9 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| elevated liver enzymes | 06/29/2015 | | | Suspected | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Concomitant medication | Ongoing | | |
| Event description: |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| elevated liver enzymes | 08/14/2015 | | | Suspected | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Drug withdrawn | Concomitant medication | Ongoing | | |
| Event description: |
| Subject received concomitant medications:Yes |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| LIV 52 | 06/29/2015 | Yes | 12/11/2015 | 6 | tablet | tid |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |