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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123551373 | 12355137 | 3 | F | 20160215 | 20160901 | 20160511 | 20160906 | EXP | JP-OTSUKA-2016_010230AA | OTSUKA | 88.31 | YR | M | Y | 66.40000 | KG | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123551373 | 12355137 | 1 | PS | Tolvaptan | TOLVAPTAN | 1 | Oral | 3.75 MG, QD, IN THE MORNING | 38 | MG | 22275 | 3.75 | MG | TABLET | QD | ||||
| 123551373 | 12355137 | 2 | SS | Tolvaptan | TOLVAPTAN | 1 | Oral | 7.5 MG, QD, IN THE MORNING | 38 | MG | 22275 | 7.5 | MG | TABLET | QD | ||||
| 123551373 | 12355137 | 3 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 20 MG, QD | 0 | 20 | MG | TABLET | QD | ||||||
| 123551373 | 12355137 | 4 | C | ISOLEUCINE W/LEUCINE/VALINE | ISOLEUCINELEUCINEVALINE | 1 | Oral | 12.45 G, QD | 0 | 12.45 | G | GRANULES | QD | ||||||
| 123551373 | 12355137 | 5 | C | Takecab | VONOPRAZAN FUMURATE | 1 | Oral | 20 MG, QD | 0 | 20 | MG | FILM-COATED TABLET | QD | ||||||
| 123551373 | 12355137 | 6 | C | ARGAMATE | CALCIUM POLYSTYRENE SULFONATE | 1 | Oral | 75 G, QD | 0 | 75 | G | GEL | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123551373 | 12355137 | 1 | Fluid retention |
| 123551373 | 12355137 | 3 | Fluid retention |
| 123551373 | 12355137 | 4 | Product used for unknown indication |
| 123551373 | 12355137 | 5 | Product used for unknown indication |
| 123551373 | 12355137 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123551373 | 12355137 | OT |
| 123551373 | 12355137 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123551373 | 12355137 | Blood creatinine increased | |
| 123551373 | 12355137 | Blood urea increased | |
| 123551373 | 12355137 | Depressed level of consciousness | |
| 123551373 | 12355137 | Disseminated intravascular coagulation | |
| 123551373 | 12355137 | Hepatocellular carcinoma | |
| 123551373 | 12355137 | Malaise | |
| 123551373 | 12355137 | Platelet count decreased | |
| 123551373 | 12355137 | Renal failure | |
| 123551373 | 12355137 | Urine output decreased | |
| 123551373 | 12355137 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 123551373 | 12355137 | 1 | 20160210 | 20160211 | 0 | |
| 123551373 | 12355137 | 2 | 20160212 | 20160302 | 0 | |
| 123551373 | 12355137 | 3 | 20160215 | 0 | ||
| 123551373 | 12355137 | 4 | 20160302 | 0 | ||
| 123551373 | 12355137 | 5 | 20160302 | 0 | ||
| 123551373 | 12355137 | 6 | 20160302 | 0 |