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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127541101 | 12754110 | 1 | I | 20160908 | 20160916 | 20160916 | EXP | IT-TEVA-692312ACC | TEVA | GENTILI M. BREAST HYPERTROPHY INDUCED BY OMBITASVIR/PARITAPREVIR/RITONAVIR AND RIBAVIRIN. BREAST JOURNAL. | 59.00 | YR | F | Y | 0.00000 | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127541101 | 12754110 | 1 | PS | RIBAVIRINA | RIBAVIRIN | 1 | 1000 MILLIGRAM DAILY; | U | 76277 | 1000 | MG | QD | |||||||
| 127541101 | 12754110 | 2 | SS | OMBITASVIR | OMBITASVIR | 1 | 12.5 MILLIGRAM DAILY; | U | 0 | 12.5 | MG | QD | |||||||
| 127541101 | 12754110 | 3 | SS | PARITAPREVIR | PARITAPREVIR | 1 | 75 MILLIGRAM DAILY; | U | 0 | 75 | MG | QD | |||||||
| 127541101 | 12754110 | 4 | SS | RITONAVIR. | RITONAVIR | 1 | 50 MILLIGRAM DAILY; | U | 0 | 50 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127541101 | 12754110 | 1 | Hepatitis C virus test positive |
| 127541101 | 12754110 | 2 | Hepatitis C virus test positive |
| 127541101 | 12754110 | 3 | Hepatitis C virus test positive |
| 127541101 | 12754110 | 4 | Hepatitis C virus test positive |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127541101 | 12754110 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127541101 | 12754110 | Anaemia | |
| 127541101 | 12754110 | Breast enlargement | |
| 127541101 | 12754110 | Fatigue | |
| 127541101 | 12754110 | Insomnia | |
| 127541101 | 12754110 | Nightmare | |
| 127541101 | 12754110 | Pollakiuria |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |