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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125346433 | 12534643 | 3 | F | 20160725 | 20160706 | 20160728 | EXP | DE-GILEAD-2016-0217419 | GILEAD | 74.00 | YR | E | F | Y | 60.00000 | KG | 20160728 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125346433 | 12534643 | 1 | PS | LEDIPASVIR/SOFOSBUVIR | LEDIPASVIRSOFOSBUVIR | 1 | Oral | 1 DF, QD | U | 205834 | 1 | DF | TABLET | QD | |||||
| 125346433 | 12534643 | 2 | SS | COPEGUS | RIBAVIRIN | 1 | Oral | 200 MG, QD | Y | 0 | 200 | MG | QD | ||||||
| 125346433 | 12534643 | 3 | C | METOPROLOL. | METOPROLOL | 1 | 5 MG, UNK | 0 | 5 | MG | |||||||||
| 125346433 | 12534643 | 4 | C | VALSARTAN. | VALSARTAN | 1 | UNK | 0 | |||||||||||
| 125346433 | 12534643 | 5 | C | L-THYROXIN | LEVOTHYROXINE SODIUM | 1 | 125 UG, UNK | 0 | 125 | UG | |||||||||
| 125346433 | 12534643 | 6 | C | GINKO BILOBA | GINKGO | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125346433 | 12534643 | 1 | Chronic hepatitis C |
| 125346433 | 12534643 | 2 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125346433 | 12534643 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125346433 | 12534643 | Abdominal discomfort | |
| 125346433 | 12534643 | Ear pain | |
| 125346433 | 12534643 | Glomerular filtration rate decreased | |
| 125346433 | 12534643 | Haemoglobin decreased | |
| 125346433 | 12534643 | Headache |
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 |
|---|---|---|---|---|---|---|
| 125346433 | 12534643 | 1 | 20150414 | 20150928 | 0 | |
| 125346433 | 12534643 | 2 | 20150414 | 20150526 | 0 | |
| 125346433 | 12534643 | 6 | 20150828 | 0 |