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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123860745 | 12386074 | 5 | F | 20151119 | 20160919 | 20160519 | 20160928 | EXP | BE-KADMON PHARMACEUTICALS, LLC-KAD201512-004629 | KADMON | 58.00 | YR | F | Y | 78.00000 | KG | 20160928 | MD | BE | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123860745 | 12386074 | 1 | PS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | TABLET | Y | 77456 | 800 | MG | TABLET | ||||||
| 123860745 | 12386074 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | Y | 77456 | 400 | MG | ||||||||
| 123860745 | 12386074 | 3 | SS | Viekirax | OMBITASVIRPARITAPREVIRRITONAVIR | 1 | Oral | Y | 0 | TABLET | QD | ||||||||
| 123860745 | 12386074 | 4 | SS | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | Y | 0 | ||||||||||
| 123860745 | 12386074 | 5 | C | Insulin | INSULIN NOS | 1 | 0 | ||||||||||||
| 123860745 | 12386074 | 6 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 123860745 | 12386074 | 7 | C | Irbesartan/hydrochlorothiazide (Karvea HCT) | 2 | 0 | |||||||||||||
| 123860745 | 12386074 | 8 | C | Cardiospirine | 2 | 0 | |||||||||||||
| 123860745 | 12386074 | 9 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123860745 | 12386074 | 1 | Hepatitis C |
| 123860745 | 12386074 | 3 | Hepatitis C |
| 123860745 | 12386074 | 5 | Type 2 diabetes mellitus |
| 123860745 | 12386074 | 7 | Hypertension |
| 123860745 | 12386074 | 9 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123860745 | 12386074 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123860745 | 12386074 | Abdominal pain | |
| 123860745 | 12386074 | Anaemia | |
| 123860745 | 12386074 | Back pain | |
| 123860745 | 12386074 | Conjunctivitis | |
| 123860745 | 12386074 | Dermatitis bullous | |
| 123860745 | 12386074 | Dyspepsia | |
| 123860745 | 12386074 | Dyspnoea | |
| 123860745 | 12386074 | Fatigue | |
| 123860745 | 12386074 | Hepatic failure | |
| 123860745 | 12386074 | Hyperkalaemia | |
| 123860745 | 12386074 | Nausea | |
| 123860745 | 12386074 | Oedema peripheral | |
| 123860745 | 12386074 | Pruritus | |
| 123860745 | 12386074 | Rash | |
| 123860745 | 12386074 | Therapy non-responder |
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 |
|---|---|---|---|---|---|---|
| 123860745 | 12386074 | 1 | 20151109 | 20151209 | 0 | |
| 123860745 | 12386074 | 2 | 20151209 | 20160222 | 0 | |
| 123860745 | 12386074 | 3 | 20151119 | 20160222 | 0 |