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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126903151 | 12690315 | 1 | I | 20160823 | 20160826 | 20160826 | EXP | JP-JNJFOC-20160819944 | JANSSEN | TAHATA Y, HIRAMATSU N, OZE T, URABE A, MORISHITA N, YAMADA R, ET AL. IMPACT OF RIBAVIRIN DOSAGE IN CHRONIC HEPATITIS C PATIENTS TREATED WITH SIMEPREVIR, PEGYLATED INTERFERON PLUS RIBAVIRIN COMBINATION THERAPY. JOURNAL OF MEDICAL VIROLOGY 01-OCT-2016;88/10:1776-1784. | 0.00 | Y | 0.00000 | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126903151 | 12690315 | 1 | PS | SOVRIAD | SIMEPREVIR | 1 | Oral | U | UNKNOWN | 205123 | 100 | MG | CAPSULE | QD | |||||
| 126903151 | 12690315 | 2 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | FOR 24 WEEKS | 0 | 180 | UG | UNSPECIFIED | /wk | ||||||
| 126903151 | 12690315 | 3 | SS | PEGINTRON | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | 60 UG TO 150 UG BASED ON BODY WEIGHT FOR 24 WEEKS | 0 | UNSPECIFIED | |||||||||
| 126903151 | 12690315 | 4 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 600 TO 1000 MG DEPENDING ON BODY WEIGHT | 0 | UNSPECIFIED | |||||||||
| 126903151 | 12690315 | 5 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | REDUCED AS PER THE BODY WEIGHT, AGE AND ITPA GENOTYPE | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126903151 | 12690315 | 1 | Chronic hepatitis C |
| 126903151 | 12690315 | 2 | Chronic hepatitis C |
| 126903151 | 12690315 | 3 | Chronic hepatitis C |
| 126903151 | 12690315 | 4 | Chronic hepatitis C |
| 126903151 | 12690315 | 5 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126903151 | 12690315 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126903151 | 12690315 | Adverse drug reaction | |
| 126903151 | 12690315 | Blood bilirubin increased | |
| 126903151 | 12690315 | Depression | |
| 126903151 | 12690315 | Fatigue | |
| 126903151 | 12690315 | Liver injury | |
| 126903151 | 12690315 | Psychiatric symptom | |
| 126903151 | 12690315 | Rash | |
| 126903151 | 12690315 | Remission not achieved | |
| 126903151 | 12690315 | Retinopathy | |
| 126903151 | 12690315 | Treatment failure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |