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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118113052 | 11811305 | 2 | F | 20160905 | 20151208 | 20160908 | EXP | DE-JNJFOC-20151202596 | JANSSEN | WERNER CR, EGETEMEYR DP, MALEK NP, LAUER UM, BERG CP. ^REAL-LIFE^-EXPERIENCE WITH SOFOSBUVIR-BASED DIRECT ACTING ANTIVIRAL TREATMENT IN HCV PATIENTS (N=187). HEPATOLOGY OCT-2015;62/1:795A. | 0.00 | Y | 0.00000 | 20160908 | OT | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118113052 | 11811305 | 1 | PS | SIMEPREVIR | SIMEPREVIR | 1 | Unknown | U | U | UNKNOWN | 205123 | CAPSULE | |||||||
| 118113052 | 11811305 | 2 | SS | SOFOSBUVIR | SOFOSBUVIR | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 118113052 | 11811305 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | U | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118113052 | 11811305 | 1 | Hepatitis C |
| 118113052 | 11811305 | 2 | Hepatitis C |
| 118113052 | 11811305 | 3 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118113052 | 11811305 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118113052 | 11811305 | Drug ineffective | |
| 118113052 | 11811305 | Hepatitis C |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |