Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124835713 | 12483571 | 3 | F | 20160719 | 20160621 | 20160721 | EXP | PL-ROCHE-1778330 | ROCHE | 45.00 | YR | F | Y | 0.00000 | 20160721 | MD | PL | PL |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124835713 | 12483571 | 1 | PS | COPEGUS | RIBAVIRIN | 1 | Unknown | 600-0-600 MG | U | 21511 | |||||||||
| 124835713 | 12483571 | 2 | SS | COPEGUS | RIBAVIRIN | 1 | Unknown | 600-0-600 MG | U | 21511 | |||||||||
| 124835713 | 12483571 | 3 | SS | ALFAFERONE | INTERFERON ALFA-N3 | 1 | Subcutaneous | Y | 0 | TIW | |||||||||
| 124835713 | 12483571 | 4 | SS | ALFAFERONE | INTERFERON ALFA-N3 | 1 | Subcutaneous | Y | 0 | BIW | |||||||||
| 124835713 | 12483571 | 5 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | 180 MCG TO 135 MCG PER WEEK | U | 103964 | 135 | UG | /wk | ||||||
| 124835713 | 12483571 | 6 | SS | SOVALDI | SOFOSBUVIR | 1 | Unknown | 1 X 1 FOR 12 WEEKS | U | 0 | 400 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124835713 | 12483571 | 1 | Hepatitis C |
| 124835713 | 12483571 | 3 | Hepatitis C |
| 124835713 | 12483571 | 5 | Hepatitis C |
| 124835713 | 12483571 | 6 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124835713 | 12483571 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124835713 | 12483571 | Alanine aminotransferase increased | |
| 124835713 | 12483571 | Anaemia | |
| 124835713 | 12483571 | Ascites | |
| 124835713 | 12483571 | Aspartate aminotransferase increased | |
| 124835713 | 12483571 | Blood albumin decreased | |
| 124835713 | 12483571 | Blood bilirubin increased | |
| 124835713 | 12483571 | Drug ineffective | |
| 124835713 | 12483571 | Fatigue | |
| 124835713 | 12483571 | Haemoglobin decreased | |
| 124835713 | 12483571 | Headache | |
| 124835713 | 12483571 | Hepatic cirrhosis | |
| 124835713 | 12483571 | International normalised ratio increased | |
| 124835713 | 12483571 | Leukopenia | |
| 124835713 | 12483571 | Neutropenia | |
| 124835713 | 12483571 | Pain in extremity | |
| 124835713 | 12483571 | Portal hypertension | |
| 124835713 | 12483571 | Thrombocytopenia | |
| 124835713 | 12483571 | Varices oesophageal |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 124835713 | 12483571 | 1 | 20130411 | 201310 | 0 | |
| 124835713 | 12483571 | 2 | 20150213 | 0 | ||
| 124835713 | 12483571 | 3 | 20130411 | 201310 | 0 | |
| 124835713 | 12483571 | 4 | 201307 | 201401 | 0 | |
| 124835713 | 12483571 | 5 | 20150213 | 0 | ||
| 124835713 | 12483571 | 6 | 20150213 | 0 |