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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125665123 | 12566512 | 3 | F | 20160219 | 20160914 | 20160718 | 20160919 | EXP | PT-INFARMED-S201605-96 | PT-GILEAD-2016-0223791 | GILEAD | 71.00 | YR | E | F | Y | 0.00000 | 20160919 | CN | PT | PT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125665123 | 12566512 | 1 | PS | HARVONI | LEDIPASVIRSOFOSBUVIR | 1 | Oral | 1 DF, QD | 205834 | 1 | DF | TABLET | QD | ||||||
| 125665123 | 12566512 | 2 | SS | REBETOL | RIBAVIRIN | 1 | Oral | 200 MG, UNK | Y | 0 | 200 | MG | |||||||
| 125665123 | 12566512 | 3 | SS | COPEGUS | RIBAVIRIN | 1 | Oral | 3 COMPRIMIDOS AO ALMO?O + 2 COMPRIMIDOS AO JANTAR | 0 | 200 | MG | ||||||||
| 125665123 | 12566512 | 4 | C | CONCOR | BISOPROLOL FUMARATE | 1 | Oral | 10 MG, UNK | 0 | 10 | MG | ||||||||
| 125665123 | 12566512 | 5 | C | CONCOR | BISOPROLOL FUMARATE | 1 | Oral | 0 | 10 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125665123 | 12566512 | 1 | Chronic hepatitis C |
| 125665123 | 12566512 | 2 | Chronic hepatitis C |
| 125665123 | 12566512 | 3 | Chronic hepatitis C |
| 125665123 | 12566512 | 4 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125665123 | 12566512 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125665123 | 12566512 | Diarrhoea | |
| 125665123 | 12566512 | Flatulence | |
| 125665123 | 12566512 | Insomnia | |
| 125665123 | 12566512 | Localised oedema | |
| 125665123 | 12566512 | Melaena | |
| 125665123 | 12566512 | Oedema peripheral | |
| 125665123 | 12566512 | Rectal discharge |
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 |
|---|---|---|---|---|---|---|
| 125665123 | 12566512 | 1 | 20160212 | 0 | ||
| 125665123 | 12566512 | 2 | 20160212 | 20160311 | 0 | |
| 125665123 | 12566512 | 3 | 20160312 | 0 |