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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118593774 | 11859377 | 4 | F | 20151118 | 20160901 | 20151221 | 20160908 | EXP | JP-GILEAD-2015-0187876 | GILEAD | 65.00 | YR | E | M | Y | 90.40000 | KG | 20160908 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118593774 | 11859377 | 1 | PS | SOVALDI | SOFOSBUVIR | 1 | Oral | 400 MG, UNK | Y | 204671 | 400 | MG | TABLET | ||||||
| 118593774 | 11859377 | 2 | SS | REBETOL | RIBAVIRIN | 1 | Oral | 800 MG, UNK | Y | 0 | 800 | MG | CAPSULE | ||||||
| 118593774 | 11859377 | 3 | SS | ANCARON | AMIODARONE HYDROCHLORIDE | 1 | Oral | 100 MG, UNK | 0 | 100 | MG | TABLET | |||||||
| 118593774 | 11859377 | 4 | C | LUPRAC | TORSEMIDE | 1 | Oral | 2 MG, UNK | 0 | 2 | MG | TABLET | QD | ||||||
| 118593774 | 11859377 | 5 | C | ALDACTONE | SPIRONOLACTONE | 1 | Oral | 25 MG, UNK | 0 | 25 | MG | TABLET | |||||||
| 118593774 | 11859377 | 6 | C | ALDACTONE | SPIRONOLACTONE | 1 | Oral | 12.5 MG, UNK | 0 | 12.5 | MG | TABLET | |||||||
| 118593774 | 11859377 | 7 | C | ARTIST | CARVEDILOL | 1 | Oral | 10 MG, UNK | 0 | 10 | MG | TABLET | QD | ||||||
| 118593774 | 11859377 | 8 | C | ARTIST | CARVEDILOL | 1 | Oral | 12.5 MG, UNK | 0 | 12.5 | MG | TABLET | QD | ||||||
| 118593774 | 11859377 | 9 | C | BLOPRESS | CANDESARTAN CILEXETIL | 1 | Oral | 8 MG, UNK | 0 | 8 | MG | TABLET | QD | ||||||
| 118593774 | 11859377 | 10 | C | LOCHOL /00638501/ | FLUVASTATIN SODIUM | 1 | Oral | 30 MG, UNK | 0 | 30 | MG | TABLET | QD | ||||||
| 118593774 | 11859377 | 11 | C | WARFARIN | WARFARIN | 1 | Oral | 3 MG, UNK | 0 | 3 | MG | TABLET | |||||||
| 118593774 | 11859377 | 12 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | 20 MG, UNK | 0 | 20 | MG | CAPSULE | |||||||
| 118593774 | 11859377 | 13 | C | URSO | URSODIOL | 1 | Unknown | 300 MG, UNK | 0 | 300 | MG | TABLET | |||||||
| 118593774 | 11859377 | 14 | C | GOREISAN /08015901/ | 2 | Unknown | 2.5 G, TID | 0 | 2.5 | G | TID | ||||||||
| 118593774 | 11859377 | 15 | C | BIOFERMIN /01617201/ | BACILLUS SUBTILISLACTOBACILLUS ACIDOPHILUSSTREPTOCOCCUS FAECAIS | 1 | Unknown | 0.66 G, QD | 0 | .66 | G | QD | |||||||
| 118593774 | 11859377 | 16 | C | DEPAS | ETIZOLAM | 1 | Unknown | 0.67 MG, QD | 0 | .67 | MG | GRANULES | QD | ||||||
| 118593774 | 11859377 | 17 | C | TERNELIN | TIZANIDINE | 1 | Oral | 200 MG, QD | 0 | 200 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118593774 | 11859377 | 1 | Chronic hepatitis C |
| 118593774 | 11859377 | 2 | Chronic hepatitis C |
| 118593774 | 11859377 | 3 | Atrial fibrillation |
| 118593774 | 11859377 | 4 | Cardiac failure |
| 118593774 | 11859377 | 5 | Cardiac failure |
| 118593774 | 11859377 | 7 | Cardiac failure |
| 118593774 | 11859377 | 9 | Cardiac failure |
| 118593774 | 11859377 | 10 | Cardiac failure |
| 118593774 | 11859377 | 11 | Atrial fibrillation |
| 118593774 | 11859377 | 12 | Gastrooesophageal reflux disease |
| 118593774 | 11859377 | 13 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118593774 | 11859377 | HO |
| 118593774 | 11859377 | OT |
| 118593774 | 11859377 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118593774 | 11859377 | Atrial fibrillation | |
| 118593774 | 11859377 | Syncope | |
| 118593774 | 11859377 | Ventricular tachycardia |
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 |
|---|---|---|---|---|---|---|
| 118593774 | 11859377 | 1 | 20151104 | 20151118 | 0 | |
| 118593774 | 11859377 | 2 | 20151104 | 20151118 | 0 | |
| 118593774 | 11859377 | 3 | 20110126 | 0 | ||
| 118593774 | 11859377 | 5 | 201511 | 0 | ||
| 118593774 | 11859377 | 6 | 201511 | 0 | ||
| 118593774 | 11859377 | 7 | 20151119 | 0 | ||
| 118593774 | 11859377 | 8 | 20151120 | 0 | ||
| 118593774 | 11859377 | 12 | 20120826 | 0 | ||
| 118593774 | 11859377 | 13 | 20150422 | 0 |