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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115159498 | 11515949 | 8 | F | 20150720 | 20160905 | 20150916 | 20160912 | EXP | DE-BRISTOL-MYERS SQUIBB COMPANY-BMS-2015-052865 | BRISTOL MYERS SQUIBB | 45.00 | YR | M | Y | 100.00000 | KG | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115159498 | 11515949 | 1 | PS | DACLATASVIR DIHYDROCHLORIDE | DACLATASVIR DIHYDROCHLORIDE | 1 | Oral | 60 MG, QD | 206843 | 60 | MG | QD | |||||||
| 115159498 | 11515949 | 2 | SS | SOFOSBUVIR | SOFOSBUVIR | 1 | Oral | 400 MG, QD | 0 | 400 | MG | QD | |||||||
| 115159498 | 11515949 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 600 MG, QD | 0 | 600 | MG | QD | |||||||
| 115159498 | 11515949 | 4 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | UNK, PRN | U | 0 | |||||||||
| 115159498 | 11515949 | 5 | SS | LIMPTAR | AMINOPHYLLINEQUININE SULFATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 115159498 | 11515949 | 6 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Unknown | 50 MG, QD | 0 | 50 | MG | QD | |||||||
| 115159498 | 11515949 | 7 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Unknown | 50 MG, BID | 0 | 50 | MG | BID | |||||||
| 115159498 | 11515949 | 8 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Unknown | 40 MG, BID | 0 | 40 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115159498 | 11515949 | 1 | Chronic hepatitis C |
| 115159498 | 11515949 | 2 | Chronic hepatitis C |
| 115159498 | 11515949 | 3 | Chronic hepatitis C |
| 115159498 | 11515949 | 4 | Product used for unknown indication |
| 115159498 | 11515949 | 5 | Product used for unknown indication |
| 115159498 | 11515949 | 6 | Product used for unknown indication |
| 115159498 | 11515949 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115159498 | 11515949 | OT |
| 115159498 | 11515949 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115159498 | 11515949 | Abdominal pain | |
| 115159498 | 11515949 | Ascites | |
| 115159498 | 11515949 | Decreased appetite | |
| 115159498 | 11515949 | Depressed mood | |
| 115159498 | 11515949 | Depression | |
| 115159498 | 11515949 | Disturbance in attention | |
| 115159498 | 11515949 | Dysgeusia | |
| 115159498 | 11515949 | Dyspnoea | |
| 115159498 | 11515949 | Epistaxis | |
| 115159498 | 11515949 | Fatigue | |
| 115159498 | 11515949 | Hepatitis C RNA increased | |
| 115159498 | 11515949 | Listless | |
| 115159498 | 11515949 | Oedema peripheral | |
| 115159498 | 11515949 | Temperature intolerance | |
| 115159498 | 11515949 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 115159498 | 11515949 | 1 | 20150720 | 0 | ||
| 115159498 | 11515949 | 2 | 20150720 | 0 | ||
| 115159498 | 11515949 | 3 | 20150720 | 0 | ||
| 115159498 | 11515949 | 5 | 20151203 | 0 | ||
| 115159498 | 11515949 | 6 | 20160130 | 0 | ||
| 115159498 | 11515949 | 7 | 20160201 | 0 |