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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 102215475 | 10221547 | 5 | F | 201402 | 20160809 | 20140606 | 20160818 | EXP | US-JNJFOC-20140519192 | JANSSEN | PERUMALSWAMI P, BICHOUPAN K, PATEL N, KU L, YALAMANCHILI R, SCHIANO T, ET AL. SIMEPREVIR AND SOFOSBUVIR REGIMENS FOR HEPATITIS C: DECOMPENSATION AND SERIOUS ADVERSE EVENTS. NATIONAL INSTITUTE OF DRUG ABUSE. PERUMALSWAMI PV, PATEL N, BICHOUPAN K, KU L, YALAMANCHILI R, HARTY A, ET AL. HIGH BASELINE BILIRUBIN AND LOW ALBUMIN PREDICT LIVER DECOMPENSATION AND SERIOUS ADVERSE EVENTS IN HCV-INFECTEDPATIENTS TREATED WITH SOFOSBUVIR-CONTAINING REGIMENS. JOURNAL OF VIRAL HEPATITIS 2016;23/9:667-676. | 47.63 | YR | A | F | Y | 0.00000 | 20160818 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 102215475 | 10221547 | 1 | PS | OLYSIO | SIMEPREVIR | 1 | Oral | Y | N | 205123 | 150 | MG | CAPSULE | QD | |||||
| 102215475 | 10221547 | 2 | SS | SOVALDI | SOFOSBUVIR | 1 | Oral | Y | 0 | 400 | MG | QD | |||||||
| 102215475 | 10221547 | 3 | SS | RIBAVIRIN. | RIBAVIRIN | 1 | Unknown | U | 0 | ||||||||||
| 102215475 | 10221547 | 4 | SS | PURINETHOL | MERCAPTOPURINE | 1 | Oral | Y | 0 | 100 | MG | UNKNOWN | |||||||
| 102215475 | 10221547 | 5 | SS | PURINETHOL | MERCAPTOPURINE | 1 | Oral | Y | 0 | 50 | MG | UNKNOWN | |||||||
| 102215475 | 10221547 | 6 | C | ENTOCORT | BUDESONIDE | 1 | Oral | 0 | 9 | MG | |||||||||
| 102215475 | 10221547 | 7 | C | ENTOCORT | BUDESONIDE | 1 | Oral | 0 | 3 | MG | |||||||||
| 102215475 | 10221547 | 8 | C | AUGMENTIN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Oral | 0 | 875 | MG | BID | ||||||||
| 102215475 | 10221547 | 9 | C | CEFEPIME | CEFEPIME HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 0 | 2 | G | Q12H | ||||||||
| 102215475 | 10221547 | 10 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 102215475 | 10221547 | 1 | Hepatitis C |
| 102215475 | 10221547 | 2 | Hepatitis C |
| 102215475 | 10221547 | 3 | Hepatitis C |
| 102215475 | 10221547 | 4 | Autoimmune hepatitis |
| 102215475 | 10221547 | 5 | Autoimmune hepatitis |
| 102215475 | 10221547 | 6 | Autoimmune hepatitis |
| 102215475 | 10221547 | 7 | Autoimmune hepatitis |
| 102215475 | 10221547 | 8 | Dysuria |
| 102215475 | 10221547 | 9 | Product used for unknown indication |
| 102215475 | 10221547 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 102215475 | 10221547 | OT |
| 102215475 | 10221547 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 102215475 | 10221547 | Autoimmune hepatitis | |
| 102215475 | 10221547 | Cough | |
| 102215475 | 10221547 | Decreased appetite | |
| 102215475 | 10221547 | Diarrhoea | |
| 102215475 | 10221547 | Drug-induced liver injury | |
| 102215475 | 10221547 | Dysuria | |
| 102215475 | 10221547 | Fatigue | |
| 102215475 | 10221547 | Jaundice | |
| 102215475 | 10221547 | Nausea | |
| 102215475 | 10221547 | Ocular icterus | |
| 102215475 | 10221547 | Off label use | |
| 102215475 | 10221547 | Peripheral swelling | |
| 102215475 | 10221547 | Pruritus generalised | |
| 102215475 | 10221547 | Pyrexia | |
| 102215475 | 10221547 | Subacute hepatic failure | |
| 102215475 | 10221547 | Tachycardia | |
| 102215475 | 10221547 | Urinary tract infection | |
| 102215475 | 10221547 | Urosepsis |
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 |
|---|---|---|---|---|---|---|
| 102215475 | 10221547 | 1 | 201402 | 201404 | 0 | |
| 102215475 | 10221547 | 2 | 201402 | 201404 | 0 | |
| 102215475 | 10221547 | 3 | 201402 | 0 | ||
| 102215475 | 10221547 | 4 | 201404 | 0 | ||
| 102215475 | 10221547 | 5 | 201404 | 0 | ||
| 102215475 | 10221547 | 6 | 201404 | 201405 | 0 | |
| 102215475 | 10221547 | 7 | 201404 | 0 | ||
| 102215475 | 10221547 | 9 | 20140527 | 0 |