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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121704743 | 12170474 | 3 | F | 20160907 | 20160311 | 20160912 | EXP | IT-ROCHE-1723695 | ROCHE | GENTILI M. BREAST HYPERTROPHY INDUCED BY OMBITASVIR/PARITAPREVIR/RITONAVIR AND RIBAVIRIN.. BREAST JOURNAL ;:-. | 0.00 | F | Y | 0.00000 | 20160912 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121704743 | 12170474 | 1 | PS | COPEGUS | RIBAVIRIN | 1 | Oral | Y | 21511 | 1000 | MG | TABLET | |||||||
| 121704743 | 12170474 | 2 | SS | VIEKIRAX | OMBITASVIRPARITAPREVIRRITONAVIR | 1 | Oral | 2 DOSAGE UNIT | Y | 0 | 2 | DF | TABLET | ||||||
| 121704743 | 12170474 | 3 | SS | EXVIERA | DASABUVIR | 1 | Oral | Y | 0 | 2 | DF | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121704743 | 12170474 | 1 | Hepatitis C |
| 121704743 | 12170474 | 2 | Hepatitis C |
| 121704743 | 12170474 | 3 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121704743 | 12170474 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121704743 | 12170474 | Anaemia | |
| 121704743 | 12170474 | Breast enlargement | |
| 121704743 | 12170474 | Fatigue | |
| 121704743 | 12170474 | Headache | |
| 121704743 | 12170474 | Insomnia | |
| 121704743 | 12170474 | Nightmare | |
| 121704743 | 12170474 | Pain in extremity | |
| 121704743 | 12170474 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 121704743 | 12170474 | 1 | 20150616 | 20150908 | 0 | |
| 121704743 | 12170474 | 2 | 20150616 | 20150908 | 0 | |
| 121704743 | 12170474 | 3 | 20150616 | 0 |