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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127678001 | 12767800 | 1 | I | 20160913 | 20160921 | 20160921 | EXP | PHHY2016IE127256 | SANDOZ | KSENIA SEVASTIANOVA, JONATHAN DEAN, CIARAN BANNAN, MIRIAM COGHLAN, GILLIAN FARRELL, CATHERINE MURRAY, CILLIAN F. DE GASCUN, COLM BERGIN. 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;82:8266-69 | 62.00 | YR | M | Y | 0.00000 | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127678001 | 12767800 | 1 | PS | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Unknown | 30 MG, AS REQUIRED | U | 90331 | 30 | MG | |||||||
| 127678001 | 12767800 | 2 | I | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Unknown | 15 MG, AS REQUIRED | U | 90331 | 15 | MG | |||||||
| 127678001 | 12767800 | 3 | I | SOFOSBUVIR | SOFOSBUVIR | 1 | Unknown | U | 0 | ||||||||||
| 127678001 | 12767800 | 4 | I | LEDIPASVIR | LEDIPASVIR | 1 | Unknown | U | 0 | ||||||||||
| 127678001 | 12767800 | 5 | I | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | 1000 MG, UNK | 0 | 1000 | MG | ||||||||
| 127678001 | 12767800 | 6 | I | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | 800 MG, UNK | 0 | 800 | MG | ||||||||
| 127678001 | 12767800 | 7 | C | TENOFOVIR | TENOFOVIR | 1 | Unknown | 245 MG, QD | U | 0 | 245 | MG | QD | ||||||
| 127678001 | 12767800 | 8 | C | ETRAVIRINE | ETRAVIRINE | 1 | Unknown | 200 MG, BID | U | 0 | 200 | MG | BID | ||||||
| 127678001 | 12767800 | 9 | C | RALTEGRAVIR. | RALTEGRAVIR | 1 | Unknown | 400 MG, BID | U | 0 | 400 | MG | BID | ||||||
| 127678001 | 12767800 | 10 | C | DARUNAVIR | DARUNAVIR | 1 | Unknown | 600 MG, BID | U | 0 | 600 | MG | BID | ||||||
| 127678001 | 12767800 | 11 | C | RITONAVIR. | RITONAVIR | 1 | Unknown | 100 MG, BID | U | 0 | 100 | MG | BID | ||||||
| 127678001 | 12767800 | 12 | C | VALACICLOVIR | VALACYCLOVIR HYDROCHLORIDE | 1 | Unknown | 500 MG, QD | U | 0 | 500 | MG | QD | ||||||
| 127678001 | 12767800 | 13 | C | PRAVASTATIN. | PRAVASTATIN | 1 | Unknown | 40 MG, QD | U | 0 | 40 | MG | QD | ||||||
| 127678001 | 12767800 | 14 | C | PROPANOLOL | PROPRANOLOL HYDROCHLORIDE | 1 | Unknown | 20 MG, BID | U | 0 | 20 | MG | BID | ||||||
| 127678001 | 12767800 | 15 | C | TADALAFIL | TADALAFIL | 1 | Unknown | 10 MG, AS REQUIRED | U | 0 | 10 | MG | |||||||
| 127678001 | 12767800 | 16 | C | PEGYLATED INTERFERON ALFA-2A | PEGINTERFERON ALFA-2A | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127678001 | 12767800 | 1 | Product used for unknown indication |
| 127678001 | 12767800 | 3 | Antiretroviral therapy |
| 127678001 | 12767800 | 4 | Antiretroviral therapy |
| 127678001 | 12767800 | 5 | Antiretroviral therapy |
| 127678001 | 12767800 | 7 | Antiretroviral therapy |
| 127678001 | 12767800 | 8 | Antiretroviral therapy |
| 127678001 | 12767800 | 9 | Antiretroviral therapy |
| 127678001 | 12767800 | 10 | Antiretroviral therapy |
| 127678001 | 12767800 | 11 | Antiretroviral therapy |
| 127678001 | 12767800 | 12 | Antiretroviral therapy |
| 127678001 | 12767800 | 13 | Antiretroviral therapy |
| 127678001 | 12767800 | 14 | Antiretroviral therapy |
| 127678001 | 12767800 | 15 | Antiretroviral therapy |
| 127678001 | 12767800 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127678001 | 12767800 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127678001 | 12767800 | Drug interaction | |
| 127678001 | 12767800 | Treatment failure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |