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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111580484 | 11158048 | 4 | F | 20141125 | 20160708 | 20150603 | 20160712 | EXP | JP-JNJFOC-20150519416 | JANSSEN | 59.79 | YR | A | F | Y | 45.00000 | KG | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111580484 | 11158048 | 1 | PS | SOVRIAD | SIMEPREVIR | 1 | Oral | N | 205123 | 100 | MG | CAPSULE | QD | ||||||
| 111580484 | 11158048 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 0 | 600 | MG | UNSPECIFIED | QD | |||||||
| 111580484 | 11158048 | 3 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | 135 | UG | INJECTION | /wk | ||||||
| 111580484 | 11158048 | 4 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | 144 | UG | INJECTION | /wk | ||||||
| 111580484 | 11158048 | 5 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | 135 | UG | INJECTION | /wk | ||||||
| 111580484 | 11158048 | 6 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | 108 | UG | INJECTION | /wk | ||||||
| 111580484 | 11158048 | 7 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | 180 | UG | INJECTION | /wk | ||||||
| 111580484 | 11158048 | 8 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | 135 | UG | INJECTION | /wk | ||||||
| 111580484 | 11158048 | 9 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | Y | 0 | 126 | UG | INJECTION | /wk | ||||||
| 111580484 | 11158048 | 10 | C | TOWATHIEM | 2 | Oral | GRANULATED POWDER | 0 | 3 | DF | POWDER | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111580484 | 11158048 | 1 | Chronic hepatitis C |
| 111580484 | 11158048 | 2 | Chronic hepatitis C |
| 111580484 | 11158048 | 3 | Chronic hepatitis C |
| 111580484 | 11158048 | 4 | Chronic hepatitis C |
| 111580484 | 11158048 | 5 | Chronic hepatitis C |
| 111580484 | 11158048 | 6 | Chronic hepatitis C |
| 111580484 | 11158048 | 7 | Chronic hepatitis C |
| 111580484 | 11158048 | 8 | Chronic hepatitis C |
| 111580484 | 11158048 | 9 | Chronic hepatitis C |
| 111580484 | 11158048 | 10 | Nasopharyngitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111580484 | 11158048 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111580484 | 11158048 | Decreased appetite | |
| 111580484 | 11158048 | Erythema | |
| 111580484 | 11158048 | Neutrophil count decreased | |
| 111580484 | 11158048 | Platelet count decreased | |
| 111580484 | 11158048 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 111580484 | 11158048 | 1 | 20141118 | 20150209 | 0 | |
| 111580484 | 11158048 | 2 | 20141118 | 20150504 | 0 | |
| 111580484 | 11158048 | 3 | 20141209 | 20141223 | 0 | |
| 111580484 | 11158048 | 4 | 20141224 | 20141228 | 0 | |
| 111580484 | 11158048 | 5 | 20141229 | 20150302 | 0 | |
| 111580484 | 11158048 | 6 | 20150303 | 20150309 | 0 | |
| 111580484 | 11158048 | 7 | 20141118 | 20141208 | 0 | |
| 111580484 | 11158048 | 8 | 20150324 | 20150504 | 0 | |
| 111580484 | 11158048 | 9 | 20150310 | 20150323 | 0 | |
| 111580484 | 11158048 | 10 | 20150217 | 20150222 | 0 |