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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125244161 | 12524416 | 1 | I | 20121009 | 20160627 | 20160704 | 20160704 | EXP | FR-009507513-1606FRA013831 | MERCK | 35.00 | YR | F | Y | 0.00000 | 20160704 | CN | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125244161 | 12524416 | 1 | PS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 400 MG, QD | 46000 | MG | 20903 | 400 | MG | CAPSULE | QD | ||||
| 125244161 | 12524416 | 2 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | Subcutaneous | 1 MICRGRAM/KG, QW | 17 | UG/KG | 0 | 1 | UG/KG | POWDER FOR INJECTION | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125244161 | 12524416 | 1 | Chronic hepatitis C |
| 125244161 | 12524416 | 2 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125244161 | 12524416 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125244161 | 12524416 | Asthenia | |
| 125244161 | 12524416 | Cardiomyopathy | |
| 125244161 | 12524416 | Decreased appetite | |
| 125244161 | 12524416 | Dyspnoea | |
| 125244161 | 12524416 | Myalgia | |
| 125244161 | 12524416 | Vitamin D deficiency |
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 |
|---|---|---|---|---|---|---|
| 125244161 | 12524416 | 1 | 20121008 | 20130130 | 0 | |
| 125244161 | 12524416 | 2 | 20121008 | 20130128 | 0 |