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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125837561 | 12583756 | 1 | I | 20160615 | 20160714 | 20160722 | 20160722 | EXP | RO-KADMON PHARMACEUTICALS, LLC-KAD201607-002679 | KADMON | 78.19 | YR | F | Y | 0.00000 | 20160722 | CN | RO | RO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125837561 | 12583756 | 1 | PS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | TABLET | Y | 77456 | TABLET | ||||||||
| 125837561 | 12583756 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Y | 77456 | |||||||||||
| 125837561 | 12583756 | 3 | SS | Viekirax | OMBITASVIRPARITAPREVIRRITONAVIR | 1 | Oral | TABLET | Y | 0 | TABLET | ||||||||
| 125837561 | 12583756 | 4 | SS | Viekirax | OMBITASVIRPARITAPREVIRRITONAVIR | 1 | Y | 0 | |||||||||||
| 125837561 | 12583756 | 5 | SS | Exviera | DASABUVIR | 1 | Oral | TABLET | Y | 0 | TABLET | ||||||||
| 125837561 | 12583756 | 6 | SS | Exviera | DASABUVIR | 1 | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125837561 | 12583756 | 1 | Hepatitis C |
| 125837561 | 12583756 | 2 | Hepatic cirrhosis |
| 125837561 | 12583756 | 3 | Hepatitis C |
| 125837561 | 12583756 | 4 | Hepatic cirrhosis |
| 125837561 | 12583756 | 5 | Hepatitis C |
| 125837561 | 12583756 | 6 | Hepatic cirrhosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125837561 | 12583756 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125837561 | 12583756 | Abdominal pain | |
| 125837561 | 12583756 | Abdominal pain upper | |
| 125837561 | 12583756 | Anaemia | |
| 125837561 | 12583756 | Asthenia | |
| 125837561 | 12583756 | Atrioventricular block | |
| 125837561 | 12583756 | Blood potassium decreased | |
| 125837561 | 12583756 | Blood sodium decreased | |
| 125837561 | 12583756 | Blood urea increased | |
| 125837561 | 12583756 | Bradycardia | |
| 125837561 | 12583756 | Dizziness | |
| 125837561 | 12583756 | Dyspnoea | |
| 125837561 | 12583756 | Fatigue | |
| 125837561 | 12583756 | Hyperbilirubinaemia | |
| 125837561 | 12583756 | Hyponatraemia | |
| 125837561 | 12583756 | Malaise | |
| 125837561 | 12583756 | Rash papular | |
| 125837561 | 12583756 | Renal failure | |
| 125837561 | 12583756 | Tremor | |
| 125837561 | 12583756 | 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 |
|---|---|---|---|---|---|---|
| 125837561 | 12583756 | 1 | 20160615 | 20160711 | 0 | |
| 125837561 | 12583756 | 3 | 20160615 | 20160711 | 0 | |
| 125837561 | 12583756 | 5 | 20160615 | 20160711 | 0 |