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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125621162 | 12562116 | 2 | F | 20160818 | 20160715 | 20160822 | EXP | BE-JNJFOC-20160711988 | JANSSEN | MORENO C, DERBALA M, NGUYEN-KHAC E, BABATIN MA, ROSA I, ALZAABI M, ET AL. SOFOSBUVIR + SIMEPREVIR +/- RIBAVIRIN TREATMENT IS EFFICIENT IN GENOTYPE 4 CHRONIC HEPATITIS C PATIENTS: RESULTS OF A LARGE INTERNATIONAL COHORT. | 0.00 | Y | 0.00000 | 20160822 | MD | BE | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125621162 | 12562116 | 1 | PS | SIMEPREVIR | SIMEPREVIR | 1 | Unknown | 12 WEEKS | U | U | UNKNOWN | 205123 | CAPSULE | ||||||
| 125621162 | 12562116 | 2 | SS | SOFOSBUVIR | SOFOSBUVIR | 1 | Unknown | 12 WEEKS | U | 0 | UNSPECIFIED | ||||||||
| 125621162 | 12562116 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | U | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125621162 | 12562116 | 1 | Hepatitis C |
| 125621162 | 12562116 | 2 | Hepatitis C |
| 125621162 | 12562116 | 3 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125621162 | 12562116 | DE |
| 125621162 | 12562116 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125621162 | 12562116 | Anaemia | |
| 125621162 | 12562116 | Asthenia | |
| 125621162 | 12562116 | Headache | |
| 125621162 | 12562116 | Hepatic failure | |
| 125621162 | 12562116 | Nausea | |
| 125621162 | 12562116 | Off label use | |
| 125621162 | 12562116 | Product use issue | |
| 125621162 | 12562116 | Pruritus | |
| 125621162 | 12562116 | Remission not achieved |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |