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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115466602 | 11546660 | 2 | F | 201411 | 20160718 | 20150924 | 20160726 | EXP | CA-GILEAD-2014-0125317 | GILEAD | 58.00 | YR | A | F | Y | 0.00000 | 20160726 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115466602 | 11546660 | 1 | PS | SOVALDI | SOFOSBUVIR | 1 | Oral | 400 MG, QD | 204671 | 400 | MG | TABLET | QD | ||||||
| 115466602 | 11546660 | 2 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | 180 ?G, Q1WK | N | 0 | 180 | UG | /wk | ||||||
| 115466602 | 11546660 | 3 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | 135 UG, Q1WK | N | 0 | 135 | UG | /wk | ||||||
| 115466602 | 11546660 | 4 | SS | PEGASYS | PEGINTERFERON ALFA-2A | 1 | Subcutaneous | 90 UG, Q1WK | N | 0 | 90 | UG | /wk | ||||||
| 115466602 | 11546660 | 5 | SS | COPEGUS | RIBAVIRIN | 1 | Oral | 1400 MG, QD | 0 | 1400 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115466602 | 11546660 | 1 | Chronic hepatitis C |
| 115466602 | 11546660 | 2 | Chronic hepatitis C |
| 115466602 | 11546660 | 5 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115466602 | 11546660 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115466602 | 11546660 | Burning sensation | |
| 115466602 | 11546660 | Fatigue | |
| 115466602 | 11546660 | Gastrooesophageal reflux disease | |
| 115466602 | 11546660 | Haematoma | |
| 115466602 | 11546660 | Influenza like illness | |
| 115466602 | 11546660 | Injection site rash | |
| 115466602 | 11546660 | Neutrophil count decreased | |
| 115466602 | 11546660 | Oedema peripheral | |
| 115466602 | 11546660 | Pruritus generalised | |
| 115466602 | 11546660 | Rash |
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 |
|---|---|---|---|---|---|---|
| 115466602 | 11546660 | 1 | 20141114 | 0 | ||
| 115466602 | 11546660 | 2 | 20141114 | 20150203 | 0 | |
| 115466602 | 11546660 | 3 | 2014 | 0 | ||
| 115466602 | 11546660 | 5 | 20141114 | 0 |