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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125369331 | 12536933 | 1 | I | 20151103 | 20160701 | 20160707 | 20160707 | EXP | IT-JNJFOC-20160701769 | JANSSEN | 72.31 | YR | E | M | Y | 0.00000 | 20160707 | PH | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125369331 | 12536933 | 1 | SS | OLYSIO | SIMEPREVIR | 1 | Oral | Y | N | 0 | CAPSULE | ||||||||
| 125369331 | 12536933 | 2 | PS | OLYSIO | SIMEPREVIR | 1 | Oral | Y | N | 205123 | 150 | MG | CAPSULE | ||||||
| 125369331 | 12536933 | 3 | SS | SOVALDI | SOFOSBUVIR | 1 | Oral | Y | 0 | FILM COATED TABLET | |||||||||
| 125369331 | 12536933 | 4 | SS | SOVALDI | SOFOSBUVIR | 1 | Oral | Y | 0 | 400 | MG | FILM COATED TABLET | |||||||
| 125369331 | 12536933 | 5 | SS | COPEGUS | RIBAVIRIN | 1 | Oral | Y | 0 | 800 | MG | CAPSULE, HARD | |||||||
| 125369331 | 12536933 | 6 | SS | COPEGUS | RIBAVIRIN | 1 | Oral | Y | 0 | CAPSULE, HARD | |||||||||
| 125369331 | 12536933 | 7 | C | LOSARTAN. | LOSARTAN | 1 | Oral | 0 | 50 | MG | FILM COATED TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125369331 | 12536933 | 1 | Hepatitis C |
| 125369331 | 12536933 | 2 | Hepatitis C |
| 125369331 | 12536933 | 3 | Hepatitis C |
| 125369331 | 12536933 | 4 | Hepatitis C |
| 125369331 | 12536933 | 5 | Hepatitis C |
| 125369331 | 12536933 | 6 | Hepatitis C |
| 125369331 | 12536933 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125369331 | 12536933 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125369331 | 12536933 | Abdominal pain | |
| 125369331 | 12536933 | Constipation | |
| 125369331 | 12536933 | Enterocolitis haemorrhagic | |
| 125369331 | 12536933 | Inflammation | |
| 125369331 | 12536933 | Intestinal obstruction | |
| 125369331 | 12536933 | Nausea | |
| 125369331 | 12536933 | 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 |
|---|---|---|---|---|---|---|
| 125369331 | 12536933 | 1 | 20151116 | 20151119 | 0 | |
| 125369331 | 12536933 | 2 | 20151007 | 20151103 | 0 | |
| 125369331 | 12536933 | 3 | 20151116 | 20151119 | 0 | |
| 125369331 | 12536933 | 4 | 20151007 | 20151103 | 0 | |
| 125369331 | 12536933 | 5 | 20151007 | 20151103 | 0 | |
| 125369331 | 12536933 | 6 | 20151116 | 20151119 | 0 |