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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126361302 | 12636130 | 2 | F | 20160604 | 20160818 | 20160809 | 20160829 | EXP | JP-ROCHE-1783637 | ROCHE | 29.43 | YR | F | Y | 44.00000 | KG | 20160829 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126361302 | 12636130 | 1 | PS | COPEGUS | RIBAVIRIN | 1 | Oral | MORNING 200 MG AND EVENING 400 MG?MOST RECENT DOSE RECEIVED ON 29/MAY/2016, 04/JUN/2016 | 21511 | 600 | MG | TABLET | |||||||
| 126361302 | 12636130 | 2 | SS | SOVALDI | SOFOSBUVIR | 1 | Oral | 0 | 400 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126361302 | 12636130 | 1 | Chronic hepatitis C |
| 126361302 | 12636130 | 2 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126361302 | 12636130 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126361302 | 12636130 | Abdominal pain lower | |
| 126361302 | 12636130 | Abortion spontaneous | |
| 126361302 | 12636130 | Genital haemorrhage | |
| 126361302 | 12636130 | Maternal exposure during pregnancy |
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 |
|---|---|---|---|---|---|---|
| 126361302 | 12636130 | 1 | 20160517 | 0 | ||
| 126361302 | 12636130 | 2 | 20160517 | 20160530 | 0 |