Non Serious Adverse Drug Reactions Report |
| Start Date:2016-10-05 End Date:2016-10-06 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:003 |
| Subject No :003-0004 | Subject Initials : | DOB :05/19/1987 | Sex:Female | Race:Caucasian | Height:174(cm) | Weight:63(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) | 12/22/2014 | 44 | |
| Visit 3 (Month 6) | 12/22/2014 | 44 | |
| Visit 1/ Baseline (Day 1) | 12/22/2014 | 44 | |
| Visit 4 (Month 9) | 12/22/2014 | 44 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| fever | 02/17/2015 | 02/18/2015 | | 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 |
| shiver | 02/17/2015 | 02/18/2015 | | 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: |
| Subject received concomitant medications |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| 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:2016-10-05 End Date:2016-10-06 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:003 |
| Subject No :003-0006 | Subject Initials : | DOB :03/28/1975 | Sex:Female | Race:Caucasian | Height:170(cm) | Weight:74(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) | 01/12/2015 | 44 | |
| Visit 3 (Month 6) | 01/12/2015 | 44 | |
| Visit 1/ Baseline (Day 1) | 01/16/2015 | 44 | |
| Visit 4 (Month 9) | 01/12/2015 | 44 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| pruritus | 06/12/2015 | 06/13/2015 | | 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 |
| local erythema | 06/12/2015 | 06/13/2015 | | 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: |
| Subject received concomitant medications:Yes |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| Methylprednisolone | 04/04/2015 | | 04/06/2015 | 500 | mg | daily |
| 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:2016-10-05 End Date:2016-10-06 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:003 |
| Subject No :003-0007 | Subject Initials : | DOB :06/18/1983 | Sex:Female | Race:Caucasian | Height:155(cm) | Weight:63(kg) |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Visit 2 (Month 3) | 01/16/2015 | 44 | |
| Visit 5 (Month12)/Early Termination | | | |
| Visit 3 (Month 6) | 01/16/2015 | 44 | |
| Visit 1/ Baseline (Day 1) | 01/16/2015 | 44 | |
| Visit 4 (Month 9) | 01/16/2015 | 44 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| fever | 03/31/2015 | 04/02/2015 | | 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 |
| shiver | 03/31/2015 | 04/02/2015 | | 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: |
| Subject received concomitant medications |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| 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:2016-10-05 End Date:2016-10-06 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:003 |
| Subject No :003-0009 | Subject Initials : | DOB :01/13/1971 | Sex:Female | Race:Caucasian | Height:170(cm) | Weight:62(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) | 02/04/2015 | 44 | |
| Visit 3 (Month 6) | 02/04/2015 | 44 | |
| Visit 1/ Baseline (Day 1) | 02/04/2015 | 44 | |
| Visit 4 (Month 9) | 02/04/2015 | 44 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| fever | 06/11/2015 | 06/12/2015 | | 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 | Resolved | | |
| Event description: |
| Subject received concomitant medications:Yes |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| Acetaminophen | 06/11/2015 | | 06/12/2015 | 500 | mg | daily |
| 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:2016-10-05 End Date:2016-10-06 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:003 |
| Subject No :003-0010 | Subject Initials : | DOB :07/22/1970 | Sex:Male | Race:Caucasian | Height:168(cm) | Weight:88(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) | 02/04/2015 | 44 | |
| Visit 1/ Baseline (Day 1) | 02/04/2015 | 44 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| flu-like illness | 03/15/2015 | 03/16/2015 | | 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: |
| Subject received concomitant medications |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| 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:2016-10-05 End Date:2016-10-06 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:003 |
| Subject No :003-0011 | Subject Initials : | DOB :07/08/1984 | Sex:Female | Race:Caucasian | Height:167(cm) | Weight:57(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) | 02/05/2015 | 44 | |
| Visit 3 (Month 6) | 02/05/2015 | 44 | |
| Visit 1/ Baseline (Day 1) | 02/05/2015 | 44 | |
| Visit 4 (Month 9) | 02/05/2015 | 44 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| low fever | 06/10/2015 | 06/12/2015 | | 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 | Resolved | | |
| Event description: |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| local erythema | 06/10/2015 | 06/12/2015 | | 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: |
| Subject received concomitant medications:Yes |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| Acetaminophen | 06/10/2015 | | 06/12/2015 | 500 | mg | daily |
| 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:2016-10-05 End Date:2016-10-06 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:003 |
| Subject No :003-0016 | Subject Initials : | DOB :10/01/1976 | Sex:Female | Race:Caucasian | Height:168(cm) | Weight:57(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) | 02/06/2015 | 44 | |
| Visit 3 (Month 6) | 02/06/2015 | 44 | |
| Visit 1/ Baseline (Day 1) | 02/06/2015 | 44 | |
| Visit 4 (Month 9) | 02/06/2015 | 44 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| local pain | 04/17/2015 | 04/18/2015 | | 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 | Resolved | | |
| Event description: |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| local erythema | 04/17/2015 | 04/18/2015 | | 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 |
| local edema | 04/17/2015 | 04/18/2015 | | 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 | Resolved | | |
| Event description: |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| pruritus | 06/08/2015 | 06/09/2015 | | 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 |
| pruritus | 09/05/2015 | 09/07/2015 | | 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 |
| local erythema | 09/05/2015 | 09/07/2015 | | 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 |
| fever | 09/05/2015 | 09/07/2015 | | 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: |
| Subject received concomitant medications:Yes |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| NSAIDs | 04/17/2015 | | 04/18/2015 | 200 | mg | daily |
| 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:2016-10-05 End Date:2016-10-06 |
| 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 | 07/24/2015 | 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 |