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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124872623 | 12487262 | 3 | F | 2016 | 20160726 | 20160622 | 20160802 | EXP | JP-009507513-1604JPN017341 | MERCK | 78.00 | YR | F | Y | 40.00000 | KG | 20160802 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124872623 | 12487262 | 1 | PS | REBETOL | RIBAVIRIN | 1 | Oral | 2 CAPSULES DAILY (DIVIDED DOSE FREQUENCY UNKNOWN) | Y | 20903 | 2 | DF | CAPSULE | QD | |||||
| 124872623 | 12487262 | 2 | SS | REBETOL | RIBAVIRIN | 1 | Oral | 1 CAPSULE DAILY (DIVIDED DOSE FREQUENCY UNKNOWN) | Y | 20903 | 1 | DF | CAPSULE | QD | |||||
| 124872623 | 12487262 | 3 | SS | SOVALDI | SOFOSBUVIR | 1 | Oral | 400 MG DAILY (DIVIDED DOSE FREQUENCY UNKNOWN) | 2800 | MG | Y | 0 | 400 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124872623 | 12487262 | 1 | Hepatic cirrhosis |
| 124872623 | 12487262 | 3 | Hepatic cirrhosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124872623 | 12487262 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124872623 | 12487262 | Condition aggravated | |
| 124872623 | 12487262 | Haemoglobin decreased | |
| 124872623 | 12487262 | Haemorrhage subcutaneous | |
| 124872623 | 12487262 | Oedema peripheral |
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 |
|---|---|---|---|---|---|---|
| 124872623 | 12487262 | 1 | 20160305 | 201603 | 0 | |
| 124872623 | 12487262 | 2 | 201603 | 20160318 | 0 | |
| 124872623 | 12487262 | 3 | 20160305 | 20160401 | 0 |