Non Serious Adverse Drug Reactions Report |
| Start Date:2016-09-24 End Date:2016-09-25 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:007 |
| Subject No :007-0010 | Subject Initials : | DOB :03/25/1989 | Sex:Male | Race:Caucasian | Height:179(cm) | Weight:63(kg) |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Visit 2 (Month 3) | 06/08/2015 | 9 | |
| Visit 5 (Month12)/Early Termination | | | |
| Visit 3 (Month 6) | 06/08/2015 | 9 | |
| Visit 1/ Baseline (Day 1) | 06/08/2015 | 9 | |
| Visit 4 (Month 9) | 06/08/2015 | 9 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| elevated liver enzymes | 09/04/2015 | 02/19/2016 | | Suspected | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | | Concomitant medication | Resolved | | |
| Event description: |
| Subject received concomitant medications:Yes |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| LIV52 | 09/04/2015 | | 01/26/2016 | 6 | tb | TID |
| Acetaminophen | 06/08/2015 | | 06/08/2015 | 500 | mg | PRN |
| Solu-Medrol | 01/27/2016 | | 01/29/2016 | 1000 | mg | QD |
| LIV 52 | 01/27/2016 | | 02/22/2016 | 3 | tb | TID |
| Controloc | 01/27/2016 | | 02/03/2016 | 20 | mg | QD |
| Rivotril 0.5mg | 01/27/2016 | Yes | | 500 | mcg | BID |
| Milgamma | 01/30/2016 | | 02/08/2016 | 3 | 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:2016-09-24 End Date:2016-09-25 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:007 |
| Subject No :007-0012 | Subject Initials : | DOB :12/11/1988 | Sex:Male | Race:Caucasian | Height:187(cm) | Weight:95(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) | 06/15/2015 | 9 | |
| Visit 3 (Month 6) | 06/15/2015 | 9 | |
| Visit 1/ Baseline (Day 1) | 06/15/2015 | 9 | |
| Visit 4 (Month 9) | 06/15/2015 | 9 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| elevated liver enzymes | 01/07/2016 | 06/20/2016 | | 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 | Resolved | | |
| Event description: |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| trombocytopenia | 03/28/2016 | 04/26/2016 | | Suspected | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Dose not changed | None | Resolved | | |
| Event description: |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| flu-like symptoms | 03/30/2016 | | | Suspected | Mild |
| 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 |
| Solu-Medrol | 08/26/2015 | | 08/28/2015 | 1000 | mg | QD |
| Spironolactona | 08/26/2015 | | 08/28/2015 | 25 | mg | QD |
| Controloc | 08/26/2015 | | 08/28/2015 | 40 | mg | QD |
| Alanerv | 08/28/2015 | | 09/28/2015 | 1 | tb | QD |
| Ibuprofenum | 03/30/2016 | Yes | | 400 | mg | PRN |
| LIV52 | 03/28/2016 | Yes | | 6 | tb | TID |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |