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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127388391 | 12738839 | 1 | I | 201409 | 20160907 | 20160913 | 20160913 | EXP | EG-GILEAD-2016-0232417 | GILEAD | 48.82 | YR | A | M | Y | 0.00000 | 20160913 | MD | EG | EG |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127388391 | 12738839 | 1 | PS | VIREAD | TENOFOVIR DISOPROXIL FUMARATE | 1 | Unknown | UNK | 21356 | TABLET | |||||||||
| 127388391 | 12738839 | 2 | C | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | 1000 MG, UNK | 0 | 1000 | MG | ||||||||
| 127388391 | 12738839 | 3 | C | PEG INF | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | 180 UG, UNK | 0 | 180 | UG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127388391 | 12738839 | 1 | Hepatitis B |
| 127388391 | 12738839 | 2 | Hepatitis C |
| 127388391 | 12738839 | 3 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127388391 | 12738839 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127388391 | 12738839 | Drug ineffective | |
| 127388391 | 12738839 | Hepatitis B DNA assay positive |
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 |
|---|---|---|---|---|---|---|
| 127388391 | 12738839 | 1 | 201409 | 0 |