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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123665162 | 12366516 | 2 | F | 20160501 | 20160719 | 20160513 | 20160725 | EXP | US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2016-035562 | BRISTOL MYERS SQUIBB | 60.69 | YR | M | Y | 0.00000 | 20160725 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123665162 | 12366516 | 1 | PS | DAKLINZA | DACLATASVIR | 1 | Oral | 1 TAB, QD | U | 206843 | 1 | DF | FILM-COATED TABLET | QD | |||||
| 123665162 | 12366516 | 2 | SS | FOLFOX | FLUOROURACILLEUCOVORIN CALCIUMOXALIPLATIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 123665162 | 12366516 | 3 | SS | SOVALDI | SOFOSBUVIR | 1 | Unknown | UNK | U | 0 | |||||||||
| 123665162 | 12366516 | 4 | SS | RIBASPHERE | RIBAVIRIN | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123665162 | 12366516 | 1 | Hepatitis C |
| 123665162 | 12366516 | 2 | Product used for unknown indication |
| 123665162 | 12366516 | 3 | Hepatitis C |
| 123665162 | 12366516 | 4 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123665162 | 12366516 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123665162 | 12366516 | Aphthous ulcer | |
| 123665162 | 12366516 | Decreased appetite | |
| 123665162 | 12366516 | Headache | |
| 123665162 | 12366516 | Hepatic cancer | |
| 123665162 | 12366516 | Oropharyngeal pain | |
| 123665162 | 12366516 | Stomatitis |
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 |
|---|---|---|---|---|---|---|
| 123665162 | 12366516 | 1 | 20160414 | 20160707 | 0 | |
| 123665162 | 12366516 | 2 | 201602 | 0 | ||
| 123665162 | 12366516 | 3 | 20160414 | 20160706 | 0 | |
| 123665162 | 12366516 | 4 | 20160414 | 20160706 | 0 |