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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124205183 | 12420518 | 3 | F | 20160815 | 20160531 | 20160818 | EXP | JP-JNJFOC-20160524271 | JANSSEN | TAKAO W, JOKO K, SEIKE H, MICHITAKA K, HORIIKE N, KISAKA Y, ET AL. SIMEPREVIR WITH PEGINTERFERON/RIBAVIRIN FOR PATIENTS WITH HEPATITIS C VIRUS GENOTYPE 1: HIGH FREQUENCY OF VIRAL RELAPSE IN ELDERLY PATIENTS. SPRINGERPLUS 2016;5:518. | 0.00 | Y | 0.00000 | 20160818 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124205183 | 12420518 | 1 | PS | SIMEPREVIR | SIMEPREVIR | 1 | Oral | FOR 12 WEEKS | U | UNKNOWN | 205123 | 100 | MG | CAPSULE | QD | ||||
| 124205183 | 12420518 | 2 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | FOR 24 WEEKS | 0 | 180 | UG | INJECTION | /wk | ||||||
| 124205183 | 12420518 | 3 | SS | COPEGUS | RIBAVIRIN | 1 | Oral | 600-1000 MG, FOR 24 WEEKS | 0 | TABLET | |||||||||
| 124205183 | 12420518 | 4 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | 1.5 MICROGRAM/KG BODY WEIGHT, FOR 24 WEEKS | 0 | 1.5 | UG/KG | INJECTION | |||||||
| 124205183 | 12420518 | 5 | SS | REBETOL | RIBAVIRIN | 1 | Oral | 600-1000 MG, FOR 24 WEEKS | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124205183 | 12420518 | 1 | Chronic hepatitis C |
| 124205183 | 12420518 | 2 | Chronic hepatitis C |
| 124205183 | 12420518 | 3 | Chronic hepatitis C |
| 124205183 | 12420518 | 4 | Chronic hepatitis C |
| 124205183 | 12420518 | 5 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124205183 | 12420518 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124205183 | 12420518 | Adverse drug reaction | |
| 124205183 | 12420518 | Anaemia | |
| 124205183 | 12420518 | Depression | |
| 124205183 | 12420518 | Fatigue | |
| 124205183 | 12420518 | Hepatitis C | |
| 124205183 | 12420518 | Remission not achieved | |
| 124205183 | 12420518 | Retinopathy | |
| 124205183 | 12420518 | Viral load increased | |
| 124205183 | 12420518 | Viral mutation identified |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |