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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109133456 | 10913345 | 6 | F | 20140509 | 20160707 | 20150313 | 20160711 | EXP | JP-JNJFOC-20150305397 | JANSSEN | 69.19 | YR | E | F | Y | 42.00000 | KG | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 109133456 | 10913345 | 1 | PS | SOVRIAD | SIMEPREVIR | 1 | Oral | N | 205123 | 100 | MG | CAPSULE | QD | ||||||
| 109133456 | 10913345 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 200 | MG | UNSPECIFIED | QD | ||||||
| 109133456 | 10913345 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 400 | MG | UNSPECIFIED | QD | ||||||
| 109133456 | 10913345 | 4 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | 0 | 1.5 | UG/KG | INJECTION | /wk | |||||||
| 109133456 | 10913345 | 5 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | 0 | 1 | UG/KG | INJECTION | /wk | |||||||
| 109133456 | 10913345 | 6 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | 0 | 1.5 | UG/KG | INJECTION | /wk | |||||||
| 109133456 | 10913345 | 7 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | 0 | 1 | UG/KG | INJECTION | /wk | |||||||
| 109133456 | 10913345 | 8 | C | VIVIANT | BAZEDOXIFENE | 1 | Oral | 0 | 20 | MG | TABLET | QD | |||||||
| 109133456 | 10913345 | 9 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | 0 | 20 | MG | CAPSULE | QD | |||||||
| 109133456 | 10913345 | 10 | C | GASMOTIN | MOSAPRIDE CITRATE | 1 | Oral | 0 | 5 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 109133456 | 10913345 | 1 | Chronic hepatitis C |
| 109133456 | 10913345 | 2 | Chronic hepatitis C |
| 109133456 | 10913345 | 3 | Chronic hepatitis C |
| 109133456 | 10913345 | 4 | Chronic hepatitis C |
| 109133456 | 10913345 | 5 | Chronic hepatitis C |
| 109133456 | 10913345 | 6 | Chronic hepatitis C |
| 109133456 | 10913345 | 7 | Chronic hepatitis C |
| 109133456 | 10913345 | 8 | Osteoporosis |
| 109133456 | 10913345 | 9 | Prophylaxis |
| 109133456 | 10913345 | 10 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 109133456 | 10913345 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 109133456 | 10913345 | Diarrhoea | |
| 109133456 | 10913345 | Eye pain | |
| 109133456 | 10913345 | Haemoglobin decreased | |
| 109133456 | 10913345 | Platelet count decreased | |
| 109133456 | 10913345 | Pruritus | |
| 109133456 | 10913345 | Pruritus generalised | |
| 109133456 | 10913345 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 109133456 | 10913345 | 1 | 20140509 | 20140731 | 0 | |
| 109133456 | 10913345 | 2 | 20140627 | 20141023 | 0 | |
| 109133456 | 10913345 | 3 | 20140509 | 20140626 | 0 | |
| 109133456 | 10913345 | 4 | 20140509 | 20140905 | 0 | |
| 109133456 | 10913345 | 5 | 20140912 | 20141017 | 0 | |
| 109133456 | 10913345 | 6 | 20140509 | 20140905 | 0 | |
| 109133456 | 10913345 | 7 | 20140912 | 20141017 | 0 | |
| 109133456 | 10913345 | 10 | 20140530 | 0 |