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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116082443 | 11608244 | 3 | F | 20140617 | 20160809 | 20151007 | 20160816 | EXP | JP-JNJFOC-20151001722 | JANSSEN | 55.62 | YR | A | F | Y | 45.00000 | KG | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116082443 | 11608244 | 1 | PS | SOVRIAD | SIMEPREVIR | 1 | Oral | Y | N | 205123 | 100 | MG | CAPSULE | QD | |||||
| 116082443 | 11608244 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 0 | 600 | MG | UNKNOWN | QD | ||||||
| 116082443 | 11608244 | 3 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | 124 | UG | INJECTION | /wk | ||||||
| 116082443 | 11608244 | 4 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | 36 | UG | INJECTION | /wk | ||||||
| 116082443 | 11608244 | 5 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | 180 | UG | INJECTION | /wk | ||||||
| 116082443 | 11608244 | 6 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | 124 | UG | INJECTION | /wk | ||||||
| 116082443 | 11608244 | 7 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | 90 | UG | INJECTION | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116082443 | 11608244 | 1 | Chronic hepatitis C |
| 116082443 | 11608244 | 2 | Chronic hepatitis C |
| 116082443 | 11608244 | 3 | Chronic hepatitis C |
| 116082443 | 11608244 | 4 | Chronic hepatitis C |
| 116082443 | 11608244 | 5 | Chronic hepatitis C |
| 116082443 | 11608244 | 6 | Chronic hepatitis C |
| 116082443 | 11608244 | 7 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116082443 | 11608244 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116082443 | 11608244 | Alanine aminotransferase increased | |
| 116082443 | 11608244 | Aspartate aminotransferase increased | |
| 116082443 | 11608244 | Neutrophil count decreased | |
| 116082443 | 11608244 | 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 |
|---|---|---|---|---|---|---|
| 116082443 | 11608244 | 1 | 20140603 | 20140805 | 0 | |
| 116082443 | 11608244 | 2 | 20140603 | 20140805 | 0 | |
| 116082443 | 11608244 | 3 | 20140722 | 20140722 | 0 | |
| 116082443 | 11608244 | 4 | 20140729 | 0 | ||
| 116082443 | 11608244 | 5 | 20140603 | 20140610 | 0 | |
| 116082443 | 11608244 | 6 | 20140617 | 20140624 | 0 | |
| 116082443 | 11608244 | 7 | 20140701 | 20140715 | 0 |