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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125623283 | 12562328 | 3 | F | 20150219 | 20160720 | 20160715 | 20160803 | EXP | DE-BRISTOL-MYERS SQUIBB COMPANY-BMS-2015-034464 | BRISTOL MYERS SQUIBB | 59.00 | YR | M | Y | 74.00000 | KG | 20160803 | CN | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125623283 | 12562328 | 1 | PS | DACLATASVIR DIHYDROCHLORIDE | DACLATASVIR DIHYDROCHLORIDE | 1 | Oral | 60 MG, QD | 4140 | MG | Y | 206843 | 60 | MG | QD | ||||
| 125623283 | 12562328 | 2 | SS | SOVALDI | SOFOSBUVIR | 1 | Oral | 400 MG, QD | 27600 | MG | Y | 0 | 400 | MG | QD | ||||
| 125623283 | 12562328 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 500 MG, BID | 69000 | MG | Y | 0 | 500 | MG | BID | ||||
| 125623283 | 12562328 | 4 | C | PANTOZOL | PANTOPRAZOLE SODIUM | 1 | Unknown | 80 MG, QD | U | 0 | 80 | MG | QD | ||||||
| 125623283 | 12562328 | 5 | C | CARVEDILOL. | CARVEDILOL | 1 | Unknown | 6.25 MG, QD | 0 | 6.25 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125623283 | 12562328 | 1 | Chronic hepatitis C |
| 125623283 | 12562328 | 2 | Chronic hepatitis C |
| 125623283 | 12562328 | 3 | Chronic hepatitis C |
| 125623283 | 12562328 | 4 | Product used for unknown indication |
| 125623283 | 12562328 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125623283 | 12562328 | HO |
| 125623283 | 12562328 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125623283 | 12562328 | Abdominal pain | |
| 125623283 | 12562328 | Cyanosis | |
| 125623283 | 12562328 | Duodenitis | |
| 125623283 | 12562328 | Fatigue | |
| 125623283 | 12562328 | Gastric disorder | |
| 125623283 | 12562328 | Headache | |
| 125623283 | 12562328 | Nasopharyngitis | |
| 125623283 | 12562328 | Oesophageal variceal ligation | |
| 125623283 | 12562328 | Portal hypertension | |
| 125623283 | 12562328 | Varices oesophageal | |
| 125623283 | 12562328 | Visual field defect |
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 |
|---|---|---|---|---|---|---|
| 125623283 | 12562328 | 1 | 20150214 | 20150731 | 0 | |
| 125623283 | 12562328 | 2 | 20150214 | 20150731 | 0 | |
| 125623283 | 12562328 | 3 | 20150214 | 20150731 | 0 | |
| 125623283 | 12562328 | 5 | 20150508 | 0 |