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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112328705 | 11232870 | 5 | F | 20150107 | 20160722 | 20150701 | 20160727 | EXP | DE-GILEAD-2015-0131040 | GILEAD | 61.00 | YR | A | M | Y | 93.00000 | KG | 20160727 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112328705 | 11232870 | 1 | PS | SOFOSBUVIR | SOFOSBUVIR | 1 | Oral | 400 MG, QD | 34800 | MG | 204671 | 400 | MG | TABLET | QD | ||||
| 112328705 | 11232870 | 2 | SS | COPEGUS | RIBAVIRIN | 1 | Oral | 1200 MG, QD | 17400 | MG | 0 | 1200 | MG | QD | |||||
| 112328705 | 11232870 | 3 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | 180 UG, Q1WK | 1800 | UG | 0 | 180 | UG | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112328705 | 11232870 | 1 | Chronic hepatitis C |
| 112328705 | 11232870 | 2 | Chronic hepatitis C |
| 112328705 | 11232870 | 3 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112328705 | 11232870 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112328705 | 11232870 | Dyspnoea | |
| 112328705 | 11232870 | Inguinal hernia | |
| 112328705 | 11232870 | Insomnia | |
| 112328705 | 11232870 | 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 |
|---|---|---|---|---|---|---|
| 112328705 | 11232870 | 1 | 20141222 | 20150315 | 0 | |
| 112328705 | 11232870 | 2 | 20141222 | 20150315 | 0 | |
| 112328705 | 11232870 | 3 | 20141222 | 20150309 | 0 |