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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125574531 | 12557453 | 1 | I | 20130529 | 20160707 | 20160714 | 20160714 | EXP | IT-KADMON PHARMACEUTICALS, LLC-KAD201607-002549 | KADMON | 29.00 | YR | M | Y | 0.00000 | 20160714 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125574531 | 12557453 | 1 | PS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | TABLET | Y | 77456 | 800 | MG | TABLET | ||||||
| 125574531 | 12557453 | 2 | SS | Telaprevir | TELAPREVIR | 1 | Oral | TABLET | Y | 0 | 2250 | MG | TABLET | ||||||
| 125574531 | 12557453 | 3 | SS | Peginterferon alfa-2a | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | SOLUTION FOR INJECTION | Y | 0 | 1.5 | UG/KG | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125574531 | 12557453 | 1 | Chronic hepatitis C |
| 125574531 | 12557453 | 2 | Chronic hepatitis C |
| 125574531 | 12557453 | 3 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125574531 | 12557453 | HO |
| 125574531 | 12557453 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125574531 | 12557453 | Fatigue | |
| 125574531 | 12557453 | Insomnia | |
| 125574531 | 12557453 | Leukopenia | |
| 125574531 | 12557453 | Musculoskeletal pain | |
| 125574531 | 12557453 | Prurigo | |
| 125574531 | 12557453 | Pyrexia | |
| 125574531 | 12557453 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125574531 | 12557453 | 1 | 20130522 | 0 | ||
| 125574531 | 12557453 | 2 | 20130703 | 20130724 | 0 | |
| 125574531 | 12557453 | 3 | 20130522 | 0 |