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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115151109 | 11515110 | 9 | F | 20150826 | 20160901 | 20150916 | 20160909 | EXP | JP-GILEAD-2015-0170898 | GILEAD | 67.00 | YR | E | F | Y | 156.00000 | KG | 20160909 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115151109 | 11515110 | 1 | PS | SOVALDI | SOFOSBUVIR | 1 | Oral | 400 MG, QD | 6000 | MG | 204671 | 400 | MG | TABLET | QD | ||||
| 115151109 | 11515110 | 2 | SS | REBETOL | RIBAVIRIN | 1 | Oral | 200 MG AM, 400 MG PM | 0 | CAPSULE | BID | ||||||||
| 115151109 | 11515110 | 3 | SS | HALFDIGOXIN | DIGOXIN | 1 | Oral | 0.125 MG, QD | 46 | MG | 0 | .125 | MG | TABLET | QD | ||||
| 115151109 | 11515110 | 4 | C | DIART | AZOSEMIDE | 1 | Oral | 45 MG, QD | 3825 | MG | 0 | 45 | MG | TABLET | QD | ||||
| 115151109 | 11515110 | 5 | C | MUCOSAL /00082801/ | 2 | Oral | 45 MG, QD | 4590 | MG | 0 | 15 | MG | TABLET | TID | |||||
| 115151109 | 11515110 | 6 | C | URSO | URSODIOL | 1 | Oral | 600 MG, QD | 0 | 200 | MG | TABLET | TID | ||||||
| 115151109 | 11515110 | 7 | C | MAINTATE | BISOPROLOL FUMARATE | 1 | Oral | 1.250 MG, QD | 0 | .625 | MG | TABLET | BID | ||||||
| 115151109 | 11515110 | 8 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | 20 MG, QD | 3660 | MG | 0 | 20 | MG | CAPSULE | QD | ||||
| 115151109 | 11515110 | 9 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Oral | 10 MG, QD | 970 | MG | 0 | 10 | MG | TABLET | QD | ||||
| 115151109 | 11515110 | 10 | C | WARFARIN /00014802/ | WARFARIN | 1 | Oral | 2 MG, QD | 0 | 2 | MG | TABLET | QD | ||||||
| 115151109 | 11515110 | 11 | C | AMBROXOL | AMBROXOL | 1 | Unknown | 45 MG, QD | 0 | 45 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115151109 | 11515110 | 1 | Hepatic cirrhosis |
| 115151109 | 11515110 | 2 | Hepatic cirrhosis |
| 115151109 | 11515110 | 3 | Atrial fibrillation |
| 115151109 | 11515110 | 4 | Right ventricular failure |
| 115151109 | 11515110 | 5 | Asthma |
| 115151109 | 11515110 | 6 | Hepatitis C |
| 115151109 | 11515110 | 7 | Atrial fibrillation |
| 115151109 | 11515110 | 8 | Gastrooesophageal reflux disease |
| 115151109 | 11515110 | 9 | Asthma |
| 115151109 | 11515110 | 10 | Atrial fibrillation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115151109 | 11515110 | DE |
| 115151109 | 11515110 | OT |
| 115151109 | 11515110 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115151109 | 11515110 | Arthralgia | |
| 115151109 | 11515110 | Diarrhoea | |
| 115151109 | 11515110 | Hyperbilirubinaemia | |
| 115151109 | 11515110 | Hypokalaemia | |
| 115151109 | 11515110 | Inflammation | |
| 115151109 | 11515110 | Malaise | |
| 115151109 | 11515110 | Meniscus injury | |
| 115151109 | 11515110 | Pyrexia | |
| 115151109 | 11515110 | Torsade de pointes | |
| 115151109 | 11515110 | Urinary tract infection | |
| 115151109 | 11515110 | Ventricular fibrillation |
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 |
|---|---|---|---|---|---|---|
| 115151109 | 11515110 | 1 | 20150818 | 20150902 | 0 | |
| 115151109 | 11515110 | 2 | 20150818 | 20150902 | 0 | |
| 115151109 | 11515110 | 3 | 20140728 | 20150902 | 0 | |
| 115151109 | 11515110 | 4 | 20150609 | 20150902 | 0 | |
| 115151109 | 11515110 | 5 | 20150523 | 20150902 | 0 | |
| 115151109 | 11515110 | 6 | 2009 | 20150902 | 0 | |
| 115151109 | 11515110 | 7 | 2009 | 20150902 | 0 | |
| 115151109 | 11515110 | 8 | 20150303 | 20150902 | 0 | |
| 115151109 | 11515110 | 9 | 20150528 | 20150902 | 0 | |
| 115151109 | 11515110 | 10 | 2009 | 20150902 | 0 | |
| 115151109 | 11515110 | 11 | 20150902 | 0 |