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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113079793 | 11307979 | 3 | F | 20160718 | 20150724 | 20160720 | EXP | US-ROCHE-1611583 | ROCHE | , PILLAI A, WEDD J, NORVELL J, PAREKH S, CHENG N, YOUNG N, SPIVEY J AND FORD R. SIMEPREVIR AND SOFOSBUVIR (SMV-SOF) FOR 12 WEEKS FOR THE TREATMENT OF CHRONIC HEPATITIS C GENOTYPE 1 INFECTION: A REAL WORLD (TRANSPLANT) HEPATOLOGY PRACTICE EXPERIENCE.. THE AMERICAN JOURNAL OF GASTROENTEROLOGY 2016 FEB 02;111:250-260. | 0.00 | Y | 0.00000 | 20160720 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113079793 | 11307979 | 1 | PS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | U | 21511 | TABLET | |||||||||
| 113079793 | 11307979 | 2 | SS | SOFOSBUVIR | SOFOSBUVIR | 1 | Oral | U | 0 | ||||||||||
| 113079793 | 11307979 | 3 | SS | SIMEPREVIR | SIMEPREVIR | 1 | Oral | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113079793 | 11307979 | 1 | Chronic hepatitis C |
| 113079793 | 11307979 | 2 | Chronic hepatitis C |
| 113079793 | 11307979 | 3 | Chronic hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113079793 | 11307979 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113079793 | 11307979 | Anaemia | |
| 113079793 | 11307979 | Bacteraemia | |
| 113079793 | 11307979 | Diarrhoea | |
| 113079793 | 11307979 | Fatigue | |
| 113079793 | 11307979 | Headache | |
| 113079793 | 11307979 | Hepatitis alcoholic | |
| 113079793 | 11307979 | Hyperbilirubinaemia | |
| 113079793 | 11307979 | Influenza | |
| 113079793 | 11307979 | Lactic acidosis | |
| 113079793 | 11307979 | Lip swelling | |
| 113079793 | 11307979 | Nausea | |
| 113079793 | 11307979 | Off label use | |
| 113079793 | 11307979 | Pancytopenia | |
| 113079793 | 11307979 | Photosensitivity reaction | |
| 113079793 | 11307979 | Pruritus |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |