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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127466021 | 12746602 | 1 | I | 20150908 | 20150911 | 20160915 | 20160915 | EXP | IT-ABBVIE-15P-083-1463337-00 | ABBVIE | GENTILI M, MAGNI C, CARNOVALE C, ET AL. BREAST HYPERTROPHY INDUCED BY OMBITASVIR/PARITAPREVIR/RITONAVIR. BREAST JOURNAL. | 59.37 | YR | F | Y | 0.00000 | 20160915 | MD | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127466021 | 12746602 | 1 | PS | VIEKIRAX | OMBITASVIRPARITAPREVIRRITONAVIR | 1 | Oral | DAILY 12.5/75/50 MG | Y | UNKNOWN | 207931 | COATED TABLET | |||||||
| 127466021 | 12746602 | 2 | SS | COPEGUS | RIBAVIRIN | 1 | Oral | DAILY | Y | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127466021 | 12746602 | 1 | Chronic hepatitis C |
| 127466021 | 12746602 | 2 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127466021 | 12746602 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127466021 | 12746602 | Anaemia | |
| 127466021 | 12746602 | Breast enlargement | |
| 127466021 | 12746602 | Fatigue | |
| 127466021 | 12746602 | Headache | |
| 127466021 | 12746602 | Insomnia | |
| 127466021 | 12746602 | Nightmare | |
| 127466021 | 12746602 | Pain in extremity | |
| 127466021 | 12746602 | Pollakiuria | |
| 127466021 | 12746602 | 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 |
|---|---|---|---|---|---|---|
| 127466021 | 12746602 | 1 | 20150616 | 20150908 | 0 | |
| 127466021 | 12746602 | 2 | 20150616 | 20150908 | 0 |