Non Serious Adverse Drug Reactions Report |
Start Date:2016-09-02 End Date:2016-09-03 |
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 | | | Suspected | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | | Concomitant medication | Ongoing | | |
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 |