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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126699741 | 12669974 | 1 | I | 2015 | 20160812 | 20160821 | 20160821 | EXP | IE-BAUSCH-BL-2016-019750 | BAUSCH AND LOMB | SEVASTIANOVA K, DEAN J, BANNAN C, COGHLAN M, FARRELL G, MURRAY C, BERGIN C, DE GASCUN C. NS5A RESISTANCE LEADING TO FAILURE OF 24-WEEK THERAPY WITH SOFOSBUVIR/LEDIPASVIR AND RIBAVIRIN FOR THE TREATMENT OF HEPATITIS C GENOTYPE 1A INFECTION IN A HIV-1 CO-INFECTED PATIENT. JOURNAL OF CLINICAL VIROLOGY. 2016;82:66-69. | 62.00 | YR | M | Y | 0.00000 | 20160821 | OT | IE | IE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126699741 | 12669974 | 1 | PS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | WEIGHT-BASED RBV | U | 18859 | |||||||||
| 126699741 | 12669974 | 2 | I | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | WEIGHT-BASED RBV | U | 18859 | |||||||||
| 126699741 | 12669974 | 3 | SS | SOFOSBUVIR W/LEDIPASVIR | LEDIPASVIRSOFOSBUVIR | 1 | Unknown | AS A SINGLE FIXED-DOSE COMBINATION | U | 0 | |||||||||
| 126699741 | 12669974 | 4 | SS | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Unknown | AS REQUIRED | U | 0 | 30 | MG | |||||||
| 126699741 | 12669974 | 5 | SS | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Unknown | AS REQUIRED | U | 0 | 15 | MG | |||||||
| 126699741 | 12669974 | 6 | C | VALACICLOVIR | VALACYCLOVIR HYDROCHLORIDE | 1 | 0 | 500 | MG | QD | |||||||||
| 126699741 | 12669974 | 7 | C | PRAVASTATIN. | PRAVASTATIN | 1 | 0 | 40 | MG | QD | |||||||||
| 126699741 | 12669974 | 8 | C | PROPANOLOL | PROPRANOLOL HYDROCHLORIDE | 1 | 0 | 20 | MG | BID | |||||||||
| 126699741 | 12669974 | 9 | C | TADALAFIL | TADALAFIL | 1 | AS REQUIRED | 0 | 10 | MG | |||||||||
| 126699741 | 12669974 | 10 | C | TENOFOVIR | TENOFOVIR | 1 | 0 | 245 | MG | QD | |||||||||
| 126699741 | 12669974 | 11 | C | ETRAVIRINE | ETRAVIRINE | 1 | 0 | 200 | MG | BID | |||||||||
| 126699741 | 12669974 | 12 | C | RALTEGRAVIR. | RALTEGRAVIR | 1 | 0 | 400 | MG | BID | |||||||||
| 126699741 | 12669974 | 13 | C | DARUNAVIR | DARUNAVIR | 1 | 0 | 600 | MG | BID | |||||||||
| 126699741 | 12669974 | 14 | C | RITONAVIR. | RITONAVIR | 1 | 0 | 100 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126699741 | 12669974 | 1 | Chronic hepatitis C |
| 126699741 | 12669974 | 3 | Chronic hepatitis C |
| 126699741 | 12669974 | 4 | Product used for unknown indication |
| 126699741 | 12669974 | 6 | Product used for unknown indication |
| 126699741 | 12669974 | 7 | Product used for unknown indication |
| 126699741 | 12669974 | 8 | Product used for unknown indication |
| 126699741 | 12669974 | 9 | Product used for unknown indication |
| 126699741 | 12669974 | 10 | Antiretroviral therapy |
| 126699741 | 12669974 | 11 | Antiretroviral therapy |
| 126699741 | 12669974 | 12 | Antiretroviral therapy |
| 126699741 | 12669974 | 13 | Antiretroviral therapy |
| 126699741 | 12669974 | 14 | Antiretroviral therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126699741 | 12669974 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126699741 | 12669974 | Anaemia | |
| 126699741 | 12669974 | Drug interaction | |
| 126699741 | 12669974 | Hepatitis C | |
| 126699741 | 12669974 | Treatment failure |
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 |
|---|---|---|---|---|---|---|
| 126699741 | 12669974 | 1 | 201502 | 2015 | 0 | |
| 126699741 | 12669974 | 2 | 2015 | 2015 | 0 | |
| 126699741 | 12669974 | 3 | 201502 | 2015 | 0 | |
| 126699741 | 12669974 | 5 | 201502 | 0 |