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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126560061 | 12656006 | 1 | I | 20160620 | 20160816 | 20160816 | PER | US-ROCHE-1781589 | ROCHE | BEAN M, TANG L, KOTTILIL S, BEAVERS K AND MEISSNER E. ON-TREATMENT ELEVATION IN HEPATIC TRANSAMINASES DURING HCV TREATMENT WITH OMBITASVIR, PARITAPREVIR, DASABUVIR, RITONAVIR, AND RIBAVIRIN: A CASE SERIES. CASE REPORTS IN INFECTIOUS DISEASES 2016;2016:1-4. | 61.00 | YR | M | Y | 0.00000 | 20160816 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126560061 | 12656006 | 1 | PS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | THERAPY COMPLETED AT 12TH WEEK | 21511 | TABLET | |||||||||
| 126560061 | 12656006 | 2 | SS | OMBITASVIR | OMBITASVIR | 1 | Unknown | THERAPY COMPLETED AT 12TH WEEK | 0 | ||||||||||
| 126560061 | 12656006 | 3 | SS | DASABUVIR | DASABUVIR | 1 | Unknown | THERAPY COMPLETED AT 12TH WEEK | 0 | ||||||||||
| 126560061 | 12656006 | 4 | SS | PARITAPREVIR | PARITAPREVIR | 1 | Unknown | THERAPY COMPLETED AT 12TH WEEK | 0 | ||||||||||
| 126560061 | 12656006 | 5 | SS | RITONAVIR. | RITONAVIR | 1 | Unknown | THERAPY COMPLETED AT 12TH WEEK | 0 | ||||||||||
| 126560061 | 12656006 | 6 | C | PRAVASTATIN. | PRAVASTATIN | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126560061 | 12656006 | 1 | Chronic hepatitis C |
| 126560061 | 12656006 | 2 | Chronic hepatitis C |
| 126560061 | 12656006 | 3 | Chronic hepatitis C |
| 126560061 | 12656006 | 4 | Chronic hepatitis C |
| 126560061 | 12656006 | 5 | Chronic hepatitis C |
| 126560061 | 12656006 | 6 | Hyperlipidaemia |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126560061 | 12656006 | Alanine aminotransferase increased | |
| 126560061 | 12656006 | Aspartate aminotransferase increased | |
| 126560061 | 12656006 | Fatigue | |
| 126560061 | 12656006 | Headache | |
| 126560061 | 12656006 | Insomnia | |
| 126560061 | 12656006 | Pruritus |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |