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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127599191 | 12759919 | 1 | I | 20160913 | 20160919 | 20160919 | EXP | IE-MYLANLABS-2016M1039928 | MYLAN | SEVASTIANOVA K, DEAN J, BANNAN C, COGHLAN M, FARRELL G, MURRAY C, ET AL. 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. J-CLIN-VIROL 2016;82:66-69. | 0.00 | Y | 0.00000 | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127599191 | 12759919 | 1 | PS | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Unknown | 30 MG AS REQUIRED; THE DOSE WAS REDUCED TO 15 MG AS REQUIRED | U | 90763 | |||||||||
| 127599191 | 12759919 | 2 | I | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Unknown | 15 MG AS REQUIRED | U | 90763 | |||||||||
| 127599191 | 12759919 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | 1000 MG, DAILY DOSE; THE DOSE WAS REDUCED TO 800MG AT WEEK 4 | U | 0 | |||||||||
| 127599191 | 12759919 | 4 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | 800 MG | U | 0 | |||||||||
| 127599191 | 12759919 | 5 | I | LEDIPASVIR W/SOFOSBUVIR | LEDIPASVIRSOFOSBUVIR | 1 | Unknown | SINGLE FIXED-DOSE COMBINATION | U | U | 0 | ||||||||
| 127599191 | 12759919 | 6 | C | ETRAVIRINE | ETRAVIRINE | 1 | Unknown | U | U | 0 | 200 | MG | BID | ||||||
| 127599191 | 12759919 | 7 | C | RALTEGRAVIR. | RALTEGRAVIR | 1 | Unknown | U | U | 0 | 400 | MG | BID | ||||||
| 127599191 | 12759919 | 8 | C | DARUNAVIR | DARUNAVIR | 1 | Unknown | U | U | 0 | 600 | MG | BID | ||||||
| 127599191 | 12759919 | 9 | C | RITONAVIR. | RITONAVIR | 1 | Unknown | U | U | 0 | 100 | MG | BID | ||||||
| 127599191 | 12759919 | 10 | C | VALACICLOVIR | VALACYCLOVIR HYDROCHLORIDE | 1 | Unknown | U | U | 0 | 500 | MG | QD | ||||||
| 127599191 | 12759919 | 11 | C | PRAVASTATIN. | PRAVASTATIN | 1 | Unknown | U | U | 0 | 40 | MG | QD | ||||||
| 127599191 | 12759919 | 12 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Unknown | U | U | 0 | 20 | MG | BID | ||||||
| 127599191 | 12759919 | 13 | C | TADALAFIL | TADALAFIL | 1 | Unknown | 10 MG AS REQUIRED | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127599191 | 12759919 | 1 | Product used for unknown indication |
| 127599191 | 12759919 | 3 | Hepatitis C |
| 127599191 | 12759919 | 5 | Hepatitis C |
| 127599191 | 12759919 | 6 | Hepatitis C |
| 127599191 | 12759919 | 7 | Hepatitis C |
| 127599191 | 12759919 | 8 | Hepatitis C |
| 127599191 | 12759919 | 9 | Hepatitis C |
| 127599191 | 12759919 | 10 | Hepatitis C |
| 127599191 | 12759919 | 11 | Product used for unknown indication |
| 127599191 | 12759919 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127599191 | 12759919 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127599191 | 12759919 | Anaemia | |
| 127599191 | 12759919 | Drug interaction | |
| 127599191 | 12759919 | Pathogen resistance |
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 |
|---|---|---|---|---|---|---|
| 127599191 | 12759919 | 3 | 201502 | 0 | ||
| 127599191 | 12759919 | 4 | 201502 | 0 | ||
| 127599191 | 12759919 | 5 | 201502 | 0 |