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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125281012 | 12528101 | 2 | F | 20160712 | 20160705 | 20160720 | EXP | IT-KADMON PHARMACEUTICALS, LLC-KAD201606-002366 | KADMON | LZZO I,ZANOTTI P,CHIRICO C,CASARI S,VILLANACCI V,SALEMME M. COLITIS DURING NEW DIRECT-ACTING ANTIVIRAL AGENTS (DAAS) THERAPY WITH SOFOSBUVIR, SIMEPREVIR AND RIBAVIRIN FOR GENOTYPE 1B HEPATITIS C. INFECTION 2016 JUN 16;. | 72.00 | YR | M | Y | 0.00000 | 20160720 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125281012 | 12528101 | 1 | PS | RIBAVIRIN. | RIBAVIRIN | 1 | Y | 76203 | |||||||||||
| 125281012 | 12528101 | 2 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Y | 76203 | 800 | MG | |||||||||
| 125281012 | 12528101 | 3 | SS | Sofosbuvir | SOFOSBUVIR | 1 | Y | 0 | 400 | MG | |||||||||
| 125281012 | 12528101 | 4 | SS | Simeprevir | SIMEPREVIR | 1 | Y | 0 | 150 | MG | |||||||||
| 125281012 | 12528101 | 5 | SS | Pegylated interferon alfa-2a | PEGINTERFERON ALFA-2A | 1 | 0 | ||||||||||||
| 125281012 | 12528101 | 6 | C | LOSARTAN. | LOSARTAN | 1 | 0 | ||||||||||||
| 125281012 | 12528101 | 7 | C | ASPIRIN. | ASPIRIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125281012 | 12528101 | 1 | Hepatitis C |
| 125281012 | 12528101 | 3 | Hepatitis C |
| 125281012 | 12528101 | 4 | Hepatitis C |
| 125281012 | 12528101 | 5 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125281012 | 12528101 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125281012 | 12528101 | Colitis | |
| 125281012 | 12528101 | Fatigue | |
| 125281012 | 12528101 | Hypotension | |
| 125281012 | 12528101 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 125281012 | 12528101 | 1 | 2001 | 0 | ||
| 125281012 | 12528101 | 2 | 20151007 | 0 | ||
| 125281012 | 12528101 | 3 | 20151007 | 0 | ||
| 125281012 | 12528101 | 4 | 20151007 | 0 | ||
| 125281012 | 12528101 | 5 | 2001 | 0 |