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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109085483 | 10908548 | 3 | F | 20140317 | 20160809 | 20150312 | 20160816 | EXP | JP-JNJFOC-20141013121 | JANSSEN | 64.01 | YR | A | F | Y | 52.00000 | KG | 20160816 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109085483 | 10908548 | 1 | PS | SOVRIAD | SIMEPREVIR | 1 | Oral | N | 205123 | 100 | MG | CAPSULE | QD | ||||||
| 109085483 | 10908548 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 600 | MG | UNSPECIFIED | QD | ||||||
| 109085483 | 10908548 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 400 | MG | UNSPECIFIED | QD | ||||||
| 109085483 | 10908548 | 4 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 600 | MG | UNSPECIFIED | QD | ||||||
| 109085483 | 10908548 | 5 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 400 | MG | UNSPECIFIED | QD | ||||||
| 109085483 | 10908548 | 6 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | 0 | 180 | UG | INJECTION | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109085483 | 10908548 | 1 | Chronic hepatitis C |
| 109085483 | 10908548 | 2 | Chronic hepatitis C |
| 109085483 | 10908548 | 3 | Chronic hepatitis C |
| 109085483 | 10908548 | 4 | Chronic hepatitis C |
| 109085483 | 10908548 | 5 | Chronic hepatitis C |
| 109085483 | 10908548 | 6 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109085483 | 10908548 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109085483 | 10908548 | Anaemia | |
| 109085483 | 10908548 | Decreased appetite | |
| 109085483 | 10908548 | Dysgeusia | |
| 109085483 | 10908548 | Platelet count decreased | |
| 109085483 | 10908548 | Pruritus |
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 |
|---|---|---|---|---|---|---|
| 109085483 | 10908548 | 1 | 20140308 | 20140529 | 0 | |
| 109085483 | 10908548 | 2 | 20140308 | 20140417 | 0 | |
| 109085483 | 10908548 | 3 | 20140418 | 20140508 | 0 | |
| 109085483 | 10908548 | 4 | 20140509 | 20140522 | 0 | |
| 109085483 | 10908548 | 5 | 20140523 | 20140821 | 0 | |
| 109085483 | 10908548 | 6 | 20140308 | 20140815 | 0 |