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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118405317 | 11840531 | 7 | F | 20151118 | 20160902 | 20151216 | 20160907 | EXP | JP-009507513-1512JPN007212 | MERCK | 65.00 | YR | M | Y | 90.40000 | KG | 20160907 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118405317 | 11840531 | 1 | PS | REBETOL | RIBAVIRIN | 1 | Oral | TOTAL DAILY DOSE: 800 MG | 11200 | MG | Y | 20903 | 800 | MG | CAPSULE | QD | |||
| 118405317 | 11840531 | 2 | SS | SOVALDI | SOFOSBUVIR | 1 | Oral | TOTAL DAILY DOSE: 400 MG | 5600 | MG | Y | 0 | 400 | MG | QD | ||||
| 118405317 | 11840531 | 3 | C | AMIODARONE HYDROCHLORIDE. | AMIODARONE HYDROCHLORIDE | 1 | Oral | 100 MG, QD, FORMULATION: POR | U | 0 | 100 | MG | POWDER FOR ORAL SOLUTION | QD | |||||
| 118405317 | 11840531 | 4 | C | AMIODARONE HYDROCHLORIDE. | AMIODARONE HYDROCHLORIDE | 1 | U | 0 | POWDER FOR ORAL SOLUTION | ||||||||||
| 118405317 | 11840531 | 5 | C | AMIODARONE HYDROCHLORIDE. | AMIODARONE HYDROCHLORIDE | 1 | U | 0 | POWDER FOR ORAL SOLUTION | ||||||||||
| 118405317 | 11840531 | 6 | C | BIOFERMIN (Bacillus subtilis (+) Lactobacillus acidophilus (+) Strepto | BACILLUS SUBTILISLACTOBACILLUS ACIDOPHILUSSTREPTOCOCCUS FAECAIS | 1 | Oral | 0.33 G, QD (FORMULATION: POR) | U | 0 | POWDER FOR ORAL SOLUTION | QD | |||||||
| 118405317 | 11840531 | 7 | C | DEPAS | ETIZOLAM | 1 | Oral | 0.67 G, QD FORMULATION: POR | U | 0 | POWDER FOR ORAL SOLUTION | QD | |||||||
| 118405317 | 11840531 | 8 | C | TERNELIN | TIZANIDINE | 1 | Oral | 1 G, QD, FORMULATION: POR | U | 0 | 1 | G | POWDER FOR ORAL SOLUTION | QD | |||||
| 118405317 | 11840531 | 9 | C | GOREI-SAN | HERBALS | 1 | Oral | 2.5 MG TID | U | 0 | 2.5 | MG | POWDER FOR ORAL SOLUTION | TID | |||||
| 118405317 | 11840531 | 10 | C | URSO | URSODIOL | 1 | Oral | 300 MG, QD, FORMULATION: POR | U | 0 | 300 | MG | POWDER FOR ORAL SOLUTION | QD | |||||
| 118405317 | 11840531 | 11 | C | LUPRAC | TORSEMIDE | 1 | Oral | 2 G, QD, FORMULATION: POR | U | 0 | 2 | G | POWDER FOR ORAL SOLUTION | QD | |||||
| 118405317 | 11840531 | 12 | C | ALDACTONE A | SPIRONOLACTONE | 1 | Oral | 25 MG, QD, FORMULATION: POR | U | 0 | 25 | MG | POWDER FOR ORAL SOLUTION | QD | |||||
| 118405317 | 11840531 | 13 | C | ARTIST | CARVEDILOL | 1 | 10 MG, QD, FORMULATION: POR | U | 0 | 10 | MG | POWDER FOR ORAL SOLUTION | QD | ||||||
| 118405317 | 11840531 | 14 | C | BLOPRESS | CANDESARTAN CILEXETIL | 1 | Oral | 8 MG, QD, FORMULATION: POR | U | 0 | 8 | MG | POWDER FOR ORAL SOLUTION | QD | |||||
| 118405317 | 11840531 | 15 | C | LOCHOL (fluvastatin sodium) | FLUVASTATIN SODIUM | 1 | Oral | 30 MG, QD, FORMULATION: POR | U | 0 | 30 | MG | POWDER FOR ORAL SOLUTION | QD | |||||
| 118405317 | 11840531 | 16 | C | WARFARIN | WARFARIN | 1 | Oral | 3 MG, QD | U | 0 | 3 | MG | POWDER FOR ORAL SOLUTION | QD | |||||
| 118405317 | 11840531 | 17 | C | ANCARON | AMIODARONE HYDROCHLORIDE | 1 | Oral | 1 DF, QD | U | 0 | 1 | DF | TABLET | QD | |||||
| 118405317 | 11840531 | 18 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | 20 MG, QD, FORMULATION: POR | U | 0 | 20 | MG | POWDER FOR ORAL SOLUTION | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118405317 | 11840531 | 1 | Chronic hepatitis C |
| 118405317 | 11840531 | 2 | Chronic hepatitis C |
| 118405317 | 11840531 | 3 | Atrial fibrillation |
| 118405317 | 11840531 | 4 | Cardiac failure |
| 118405317 | 11840531 | 5 | Ventricular tachycardia |
| 118405317 | 11840531 | 10 | Hepatitis C |
| 118405317 | 11840531 | 11 | Cardiac failure |
| 118405317 | 11840531 | 12 | Cardiac failure |
| 118405317 | 11840531 | 13 | Cardiac failure |
| 118405317 | 11840531 | 14 | Cardiac failure |
| 118405317 | 11840531 | 15 | Cardiac failure |
| 118405317 | 11840531 | 16 | Atrial fibrillation |
| 118405317 | 11840531 | 18 | Gastrooesophageal reflux disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118405317 | 11840531 | HO |
| 118405317 | 11840531 | LT |
| 118405317 | 11840531 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118405317 | 11840531 | Atrial fibrillation | |
| 118405317 | 11840531 | Syncope | |
| 118405317 | 11840531 | 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 |
|---|---|---|---|---|---|---|
| 118405317 | 11840531 | 1 | 20151105 | 20151118 | 0 | |
| 118405317 | 11840531 | 2 | 20151105 | 20151118 | 0 | |
| 118405317 | 11840531 | 3 | 20110126 | 0 | ||
| 118405317 | 11840531 | 10 | 20150422 | 0 |