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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125666251 | 12566625 | 1 | I | 20160708 | 20160718 | 20160718 | EXP | BR-BRISTOL-MYERS SQUIBB COMPANY-BMS-2016-057382 | BRISTOL MYERS SQUIBB | 62.00 | YR | F | Y | 0.00000 | 20160718 | MD | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125666251 | 12566625 | 1 | PS | DACLATASVIR DIHYDROCHLORIDE | DACLATASVIR DIHYDROCHLORIDE | 1 | Unknown | 60 MG, UNK | U | 206843 | 60 | MG | FILM-COATED TABLET | ||||||
| 125666251 | 12566625 | 2 | SS | DACLATASVIR DIHYDROCHLORIDE | DACLATASVIR DIHYDROCHLORIDE | 1 | U | 206843 | FILM-COATED TABLET | ||||||||||
| 125666251 | 12566625 | 3 | SS | SOFOSBUVIR | SOFOSBUVIR | 1 | Unknown | 400 MG, UNK | U | 0 | 400 | MG | |||||||
| 125666251 | 12566625 | 4 | SS | SOFOSBUVIR | SOFOSBUVIR | 1 | U | 0 | |||||||||||
| 125666251 | 12566625 | 5 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | 750 MG, UNK | U | 0 | 750 | MG | |||||||
| 125666251 | 12566625 | 6 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125666251 | 12566625 | 1 | Hepatitis C |
| 125666251 | 12566625 | 2 | Hepatic cirrhosis |
| 125666251 | 12566625 | 3 | Hepatitis C |
| 125666251 | 12566625 | 4 | Hepatic cirrhosis |
| 125666251 | 12566625 | 5 | Hepatitis C |
| 125666251 | 12566625 | 6 | Hepatic cirrhosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125666251 | 12566625 | OT |
| 125666251 | 12566625 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125666251 | 12566625 | Depression | |
| 125666251 | 12566625 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 125666251 | 12566625 | 5 | 20160427 | 0 |