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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123733314 | 12373331 | 4 | F | 20160416 | 20160809 | 20160516 | 20160818 | EXP | IE-HPRA-2016-026575 | IE-BRISTOL-MYERS SQUIBB COMPANY-BMS-2016-036143 | BRISTOL MYERS SQUIBB | 58.00 | YR | M | Y | 0.00000 | 20160818 | CN | IE | IE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123733314 | 12373331 | 1 | PS | DAKLINZA | DACLATASVIR | 1 | Oral | 60 MG, QD | 206843 | 60 | MG | FILM-COATED TABLET | QD | ||||||
| 123733314 | 12373331 | 2 | SS | MODERIBA | RIBAVIRIN | 1 | Oral | 1 DF, UNK | 0 | 1 | DF | FILM-COATED TABLET | |||||||
| 123733314 | 12373331 | 3 | SS | SOVALDI | SOFOSBUVIR | 1 | Oral | 400 MG, QD | 0 | 400 | MG | FILM-COATED TABLET | QD | ||||||
| 123733314 | 12373331 | 4 | SS | CELLCEPT | MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE | 1 | Oral | 500 MG, BID | 0 | 500 | MG | BID | |||||||
| 123733314 | 12373331 | 5 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | U | 0 | ||||||||||
| 123733314 | 12373331 | 6 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Unknown | U | 0 | CAPSULE, HARD | |||||||||
| 123733314 | 12373331 | 7 | C | LAMIVUDINE. | LAMIVUDINE | 1 | Unknown | U | 0 | ||||||||||
| 123733314 | 12373331 | 8 | C | INSUMAN | INSULIN HUMAN | 1 | Unknown | U | 0 | SUSPENSION FOR INJECTION | |||||||||
| 123733314 | 12373331 | 9 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | U | 0 | FILM-COATED TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123733314 | 12373331 | 1 | Hepatitis C |
| 123733314 | 12373331 | 2 | Hepatitis |
| 123733314 | 12373331 | 3 | Hepatitis |
| 123733314 | 12373331 | 4 | Transplant |
| 123733314 | 12373331 | 5 | Product used for unknown indication |
| 123733314 | 12373331 | 6 | Product used for unknown indication |
| 123733314 | 12373331 | 7 | Product used for unknown indication |
| 123733314 | 12373331 | 8 | Product used for unknown indication |
| 123733314 | 12373331 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123733314 | 12373331 | DS |
| 123733314 | 12373331 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123733314 | 12373331 | Facial paralysis | |
| 123733314 | 12373331 | Off label use | |
| 123733314 | 12373331 | Pain |
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 |
|---|---|---|---|---|---|---|
| 123733314 | 12373331 | 1 | 20160408 | 0 | ||
| 123733314 | 12373331 | 2 | 20160408 | 0 | ||
| 123733314 | 12373331 | 3 | 20160408 | 0 | ||
| 123733314 | 12373331 | 4 | 20160408 | 0 |