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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104325077 | 10432507 | 7 | F | 20140408 | 20160729 | 20140905 | 20160803 | EXP | JP-JNJFOC-20140901546 | JANSSEN | 56.04 | YR | A | F | Y | 43.00000 | KG | 20160803 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104325077 | 10432507 | 1 | PS | SOVRIAD | SIMEPREVIR | 1 | Oral | N | 205123 | 100 | MG | CAPSULE | QD | ||||||
| 104325077 | 10432507 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 600 | MG | QD | |||||||
| 104325077 | 10432507 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 400 | MG | QD | |||||||
| 104325077 | 10432507 | 4 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 400 | MG | QD | |||||||
| 104325077 | 10432507 | 5 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 600 | MG | QD | |||||||
| 104325077 | 10432507 | 6 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 400 | MG | QD | |||||||
| 104325077 | 10432507 | 7 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 200 | MG | QD | |||||||
| 104325077 | 10432507 | 8 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | 0 | 1.38 | UG/KG | INJECTION | /wk | |||||||
| 104325077 | 10432507 | 9 | C | LOCHOL | FLUVASTATIN SODIUM | 1 | Oral | 0 | 30 | MG | QD | ||||||||
| 104325077 | 10432507 | 10 | C | EPADEL S | ICOSAPENT ETHYL | 1 | Oral | 0 | 1800 | MG | QD | ||||||||
| 104325077 | 10432507 | 11 | C | PROMAC (POLAPREZINC) | POLAPREZINC | 1 | Oral | 0 | 150 | MG | QD | ||||||||
| 104325077 | 10432507 | 12 | C | POLAPREZINC | POLAPREZINC | 1 | Oral | 0 | 150 | MG | UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 104325077 | 10432507 | 1 | Chronic hepatitis C |
| 104325077 | 10432507 | 2 | Chronic hepatitis C |
| 104325077 | 10432507 | 3 | Chronic hepatitis C |
| 104325077 | 10432507 | 4 | Chronic hepatitis C |
| 104325077 | 10432507 | 5 | Chronic hepatitis C |
| 104325077 | 10432507 | 6 | Chronic hepatitis C |
| 104325077 | 10432507 | 7 | Chronic hepatitis C |
| 104325077 | 10432507 | 8 | Chronic hepatitis C |
| 104325077 | 10432507 | 9 | Chronic hepatitis C |
| 104325077 | 10432507 | 10 | Prophylaxis |
| 104325077 | 10432507 | 11 | Prophylaxis |
| 104325077 | 10432507 | 12 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 104325077 | 10432507 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 104325077 | 10432507 | Anaemia | |
| 104325077 | 10432507 | Decreased appetite | |
| 104325077 | 10432507 | Insomnia | |
| 104325077 | 10432507 | Pyrexia | |
| 104325077 | 10432507 | Rash pruritic | |
| 104325077 | 10432507 | 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 |
|---|---|---|---|---|---|---|
| 104325077 | 10432507 | 1 | 20140408 | 20140629 | 0 | |
| 104325077 | 10432507 | 2 | 20140408 | 20140511 | 0 | |
| 104325077 | 10432507 | 3 | 20140811 | 20140922 | 0 | |
| 104325077 | 10432507 | 4 | 20140512 | 20140622 | 0 | |
| 104325077 | 10432507 | 5 | 20140623 | 20140713 | 0 | |
| 104325077 | 10432507 | 6 | 20140714 | 20150727 | 0 | |
| 104325077 | 10432507 | 7 | 20140728 | 20140810 | 0 | |
| 104325077 | 10432507 | 8 | 20140408 | 20140915 | 0 | |
| 104325077 | 10432507 | 9 | 20140408 | 20140511 | 0 | |
| 104325077 | 10432507 | 10 | 20140408 | 20140511 | 0 | |
| 104325077 | 10432507 | 11 | 20140408 | 20140511 | 0 | |
| 104325077 | 10432507 | 12 | 20140408 | 20140511 | 0 |