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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125815932 | 12581593 | 2 | F | 20160329 | 20160804 | 20160722 | 20160811 | EXP | US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2016-058470 | BRISTOL MYERS SQUIBB | 58.52 | YR | F | Y | 77.98000 | KG | 20160811 | PH | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125815932 | 12581593 | 1 | PS | DAKLINZA | DACLATASVIR | 1 | Oral | 60 MG, QD | U | U | 206843 | 60 | MG | FILM-COATED TABLET | QD | ||||
| 125815932 | 12581593 | 2 | SS | SOVALDI | SOFOSBUVIR | 1 | Unknown | 400 MG, QD | U | 0 | 400 | MG | QD | ||||||
| 125815932 | 12581593 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | 600 MG, BID | U | 0 | 600 | MG | BID | ||||||
| 125815932 | 12581593 | 4 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Unknown | 20 MG, QD | U | 0 | 20 | MG | QD | ||||||
| 125815932 | 12581593 | 5 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 20 MG, QD | U | 0 | 20 | MG | QD | ||||||
| 125815932 | 12581593 | 6 | C | ALDACTONE | SPIRONOLACTONE | 1 | Unknown | 50 MG, UNK | U | 0 | 50 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125815932 | 12581593 | 1 | Hepatitis C |
| 125815932 | 12581593 | 2 | Hepatitis C |
| 125815932 | 12581593 | 3 | Hepatitis C |
| 125815932 | 12581593 | 4 | Oedema |
| 125815932 | 12581593 | 5 | Gastrooesophageal reflux disease |
| 125815932 | 12581593 | 6 | Oedema |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125815932 | 12581593 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125815932 | 12581593 | Confusional state | |
| 125815932 | 12581593 | Decreased appetite | |
| 125815932 | 12581593 | Hepatic encephalopathy | |
| 125815932 | 12581593 | Insomnia | |
| 125815932 | 12581593 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 125815932 | 12581593 | 1 | 20160326 | 0 |