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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124092412 | 12409241 | 2 | F | 20150606 | 20160621 | 20160526 | 20160701 | EXP | RO-KADMON PHARMACEUTICALS, LLC-KAD201605-001905 | KADMON | 63.74 | YR | M | Y | 0.00000 | 20160630 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124092412 | 12409241 | 1 | PS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | FILM-COATED TABLET | 77456 | FILM-COATED TABLET | BID | ||||||||
| 124092412 | 12409241 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | 77456 | ||||||||||||
| 124092412 | 12409241 | 3 | SS | Viekirax | OMBITASVIRPARITAPREVIRRITONAVIR | 1 | Oral | FILM-COATED TABLET | 0 | FILM-COATED TABLET | BID | ||||||||
| 124092412 | 12409241 | 4 | SS | Viekirax | OMBITASVIRPARITAPREVIRRITONAVIR | 1 | 0 | ||||||||||||
| 124092412 | 12409241 | 5 | SS | Exviera | DASABUVIR | 1 | Oral | FILM-COATED TABLET, 1 IN THE MORNING AND EVENING (1-0-1) | 0 | FILM-COATED TABLET | BID | ||||||||
| 124092412 | 12409241 | 6 | SS | Exviera | DASABUVIR | 1 | 0 | ||||||||||||
| 124092412 | 12409241 | 7 | C | Tertensif | 2 | Oral | TABLET | 0 | TABLET | QOD | |||||||||
| 124092412 | 12409241 | 8 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Oral | TABLET | 0 | TABLET | |||||||||
| 124092412 | 12409241 | 9 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 0 | BID | ||||||||||
| 124092412 | 12409241 | 10 | C | Furosemid | FUROSEMIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124092412 | 12409241 | 1 | Hepatitis C |
| 124092412 | 12409241 | 2 | Hepatic cirrhosis |
| 124092412 | 12409241 | 3 | Hepatitis C |
| 124092412 | 12409241 | 4 | Hepatic cirrhosis |
| 124092412 | 12409241 | 5 | Hepatitis C |
| 124092412 | 12409241 | 6 | Hepatic cirrhosis |
| 124092412 | 12409241 | 7 | Hypertension |
| 124092412 | 12409241 | 8 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124092412 | 12409241 | DE |
| 124092412 | 12409241 | LT |
| 124092412 | 12409241 | HO |
| 124092412 | 12409241 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124092412 | 12409241 | Abdominal distension | |
| 124092412 | 12409241 | Abdominal pain | |
| 124092412 | 12409241 | Ascites | |
| 124092412 | 12409241 | Coagulopathy | |
| 124092412 | 12409241 | Diarrhoea | |
| 124092412 | 12409241 | Enterocolitis | |
| 124092412 | 12409241 | Flatulence | |
| 124092412 | 12409241 | Generalised oedema | |
| 124092412 | 12409241 | Hepatic failure | |
| 124092412 | 12409241 | Nausea | |
| 124092412 | 12409241 | Oedema peripheral | |
| 124092412 | 12409241 | Peritonitis bacterial | |
| 124092412 | 12409241 | Upper limb fracture | |
| 124092412 | 12409241 | 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 |
|---|---|---|---|---|---|---|
| 124092412 | 12409241 | 1 | 20160314 | 20160415 | 0 | |
| 124092412 | 12409241 | 3 | 20160314 | 20160516 | 0 | |
| 124092412 | 12409241 | 5 | 20160314 | 20160516 | 0 |