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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105573056 | 10557305 | 6 | F | 20140418 | 20160805 | 20141031 | 20160809 | EXP | JP-JNJFOC-20141019108 | JANSSEN | 67.46 | YR | E | F | Y | 37.00000 | KG | 20160809 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105573056 | 10557305 | 1 | PS | SOVRIAD | SIMEPREVIR | 1 | Oral | N | 205123 | 100 | MG | CAPSULE | QD | ||||||
| 105573056 | 10557305 | 2 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | 0 | 1.5 | UG/KG | INJECTION | /wk | |||||||
| 105573056 | 10557305 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 0 | 400 | MG | UNSPECIFIED | QD | |||||||
| 105573056 | 10557305 | 4 | C | HIRUDOID | GLYCOSAMINOGLYCANS | 1 | Topical | 0 | LOTION | ||||||||||
| 105573056 | 10557305 | 5 | C | URSO | URSODIOL | 1 | Oral | 0 | 600 | MG | TABLET | QD | |||||||
| 105573056 | 10557305 | 6 | C | DEPAS | ETIZOLAM | 1 | Oral | 0 | 1 | MG | TABLET | QD | |||||||
| 105573056 | 10557305 | 7 | C | BLOPRESS | CANDESARTAN CILEXETIL | 1 | Oral | 0 | 4 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 105573056 | 10557305 | 1 | Chronic hepatitis C |
| 105573056 | 10557305 | 2 | Chronic hepatitis C |
| 105573056 | 10557305 | 3 | Chronic hepatitis C |
| 105573056 | 10557305 | 4 | Asteatosis |
| 105573056 | 10557305 | 5 | Chronic hepatitis C |
| 105573056 | 10557305 | 6 | Insomnia |
| 105573056 | 10557305 | 7 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 105573056 | 10557305 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 105573056 | 10557305 | Anaemia | |
| 105573056 | 10557305 | Faeces soft | |
| 105573056 | 10557305 | Injection site induration | |
| 105573056 | 10557305 | Nausea | |
| 105573056 | 10557305 | Platelet count decreased | |
| 105573056 | 10557305 | Rash | |
| 105573056 | 10557305 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 105573056 | 10557305 | 1 | 20140411 | 20140703 | 0 | |
| 105573056 | 10557305 | 2 | 20140411 | 20140919 | 0 | |
| 105573056 | 10557305 | 3 | 20140411 | 20140925 | 0 | |
| 105573056 | 10557305 | 4 | 20140704 | 0 |