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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126677023 | 12667702 | 3 | F | 2016 | 20160902 | 20160819 | 20160912 | EXP | JP-009507513-1608JPN007507 | MERCK | 65.00 | YR | M | Y | 72.00000 | KG | 20160912 | PH | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126677023 | 12667702 | 1 | PS | REBETOL | RIBAVIRIN | 1 | Oral | 400 MG, 1 DAY, DIVIDED DOSE FREQUENCY UNKNOWN | 20903 | 400 | MG | CAPSULE | QD | ||||||
| 126677023 | 12667702 | 2 | SS | SOVALDI | SOFOSBUVIR | 1 | Oral | 400 MG 1 DAY, DIVIDED DOSE FREQUENCY UNKNOWN | U | 0 | 400 | MG | TABLET | QD | |||||
| 126677023 | 12667702 | 3 | SS | SOVALDI | SOFOSBUVIR | 1 | Oral | 400 MG, QD, DIVIDED DOSE FREQUENCY UNKNOWN | U | 0 | 400 | MG | TABLET | QD | |||||
| 126677023 | 12667702 | 4 | SS | SOVALDI | SOFOSBUVIR | 1 | Oral | 400 MG, QD, DIVIDED DOSE FREQUENCY UNKNOWN | U | 0 | 400 | MG | TABLET | QD | |||||
| 126677023 | 12667702 | 5 | C | GASTER | FAMOTIDINE | 1 | Oral | 2 DF, QD, DIVIDED DOSE FREQUENCY UNKNOWN | 0 | 2 | DF | WAFER | QD | ||||||
| 126677023 | 12667702 | 6 | C | URSO | URSODIOL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126677023 | 12667702 | 1 | Hepatic cirrhosis |
| 126677023 | 12667702 | 2 | Hepatic cirrhosis |
| 126677023 | 12667702 | 5 | Gastrooesophageal reflux disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126677023 | 12667702 | HO |
| 126677023 | 12667702 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126677023 | 12667702 | Abdominal distension | |
| 126677023 | 12667702 | Decreased appetite | |
| 126677023 | 12667702 | Hepatitis | |
| 126677023 | 12667702 | Ileus | |
| 126677023 | 12667702 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 126677023 | 12667702 | 1 | 20151212 | 20160205 | 0 | |
| 126677023 | 12667702 | 2 | 20151212 | 20160205 | 0 | |
| 126677023 | 12667702 | 3 | 20160206 | 20160208 | 0 | |
| 126677023 | 12667702 | 4 | 20160810 | 0 | ||
| 126677023 | 12667702 | 5 | 20150926 | 20160205 | 0 |