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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126153791 | 12615379 | 1 | I | 20160302 | 20160727 | 20160802 | 20160802 | EXP | JP-OTSUKA-2016_018384 | OTSUKA | 80.93 | YR | M | Y | 69.00000 | KG | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126153791 | 12615379 | 1 | PS | Tolvaptan | TOLVAPTAN | 1 | Oral | 3.75 MG, QD IN THE MORNING | 29.7140007 | MG | Y | 22275 | 3.75 | MG | TABLET | QD | |||
| 126153791 | 12615379 | 2 | SS | Tolvaptan | TOLVAPTAN | 1 | Oral | 7.5MG, QD IN THE MORNING | 29.7140007 | MG | Y | 22275 | 7.5 | MG | TABLET | QD | |||
| 126153791 | 12615379 | 3 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 20 MG, DAILY DOSE | Y | 0 | 20 | MG | TABLET | ||||||
| 126153791 | 12615379 | 4 | SS | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 50 MG, DAILY DOSE | Y | 0 | 50 | MG | TABLET | ||||||
| 126153791 | 12615379 | 5 | SS | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 25 MG, DAILY DOSE | Y | 0 | 25 | MG | TABLET | ||||||
| 126153791 | 12615379 | 6 | SS | FURUSEMIDE | FUROSEMIDE | 1 | Intravenous (not otherwise specified) | 20 MG, DAILY DOSE | Y | 0 | 20 | MG | INJECTION | ||||||
| 126153791 | 12615379 | 7 | C | KENKETU Albumin 25% I.V. BENESIS | 2 | Intravenous (not otherwise specified) | 100 ML, DAILY DOSE | 0 | 100 | ML | INJECTION | ||||||||
| 126153791 | 12615379 | 8 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | 15 MG, DAILY DOSE | 0 | 15 | MG | ORODISPERSIBLE TABLET | |||||||
| 126153791 | 12615379 | 9 | C | URSODEOXYCHOLIC ACID | URSODIOL | 1 | Oral | 600 MG, DAILY DOSE | 0 | 600 | MG | TABLET | |||||||
| 126153791 | 12615379 | 10 | C | LIVACT | AMINO ACIDS | 1 | Oral | 12.45 MG, DAILY DOSE | 0 | 12.45 | MG | GRANULES | |||||||
| 126153791 | 12615379 | 11 | C | SUREPOST | REPAGLINIDE | 1 | Oral | 0.25 MG, DAILY DOSE | 0 | .5 | MG | TABLET | |||||||
| 126153791 | 12615379 | 12 | C | SUREPOST | REPAGLINIDE | 1 | Oral | 0.25 MG, DAILY DOSE | 0 | .25 | MG | TABLET | |||||||
| 126153791 | 12615379 | 13 | C | SENNOSIDE A+B CALCIUM | SENNOSIDES A AND B | 1 | Oral | 24 MG, PRN | 0 | 24 | MG | TABLET | |||||||
| 126153791 | 12615379 | 14 | C | CALONAL | ACETAMINOPHEN | 1 | Oral | 1 G, PRN | 0 | 1 | G | GRANULES | |||||||
| 126153791 | 12615379 | 15 | C | CALONAL | ACETAMINOPHEN | 1 | 0 | GRANULES | |||||||||||
| 126153791 | 12615379 | 16 | C | OTSUKA NORMAL SALINE | 2 | Intravenous (not otherwise specified) | 500 ML, DAILY DOSE | 0 | 500 | ML | INJECTION | ||||||||
| 126153791 | 12615379 | 17 | C | OTSUKA NORMAL SALINE | 2 | Intravenous (not otherwise specified) | 100 ML, DAILY DOSE | 0 | 100 | ML | INJECTION | ||||||||
| 126153791 | 12615379 | 18 | C | OTSUKA NORMAL SALINE | 2 | Intravenous (not otherwise specified) | 100 ML, DAILY DOSE | 0 | 100 | ML | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126153791 | 12615379 | 1 | Fluid retention |
| 126153791 | 12615379 | 3 | Fluid retention |
| 126153791 | 12615379 | 4 | Fluid retention |
| 126153791 | 12615379 | 6 | Fluid retention |
| 126153791 | 12615379 | 7 | Fluid replacement |
| 126153791 | 12615379 | 8 | Product used for unknown indication |
| 126153791 | 12615379 | 9 | Product used for unknown indication |
| 126153791 | 12615379 | 10 | Product used for unknown indication |
| 126153791 | 12615379 | 11 | Product used for unknown indication |
| 126153791 | 12615379 | 13 | Product used for unknown indication |
| 126153791 | 12615379 | 14 | Pyrexia |
| 126153791 | 12615379 | 15 | Pain |
| 126153791 | 12615379 | 16 | Fluid replacement |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126153791 | 12615379 | LT |
| 126153791 | 12615379 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126153791 | 12615379 | Alanine aminotransferase increased | |
| 126153791 | 12615379 | Aspartate aminotransferase increased | |
| 126153791 | 12615379 | Dehydration | |
| 126153791 | 12615379 | Hepatic encephalopathy | |
| 126153791 | 12615379 | Hepatic failure | |
| 126153791 | 12615379 | Thirst |
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 |
|---|---|---|---|---|---|---|
| 126153791 | 12615379 | 1 | 20160301 | 20160314 | 0 | |
| 126153791 | 12615379 | 2 | 20160315 | 20160508 | 0 | |
| 126153791 | 12615379 | 3 | 20160508 | 0 | ||
| 126153791 | 12615379 | 4 | 20160318 | 0 | ||
| 126153791 | 12615379 | 5 | 20160319 | 20160508 | 0 | |
| 126153791 | 12615379 | 6 | 20160504 | 20160508 | 0 | |
| 126153791 | 12615379 | 7 | 20160506 | 20160506 | 0 | |
| 126153791 | 12615379 | 11 | 20160317 | 0 | ||
| 126153791 | 12615379 | 12 | 20160318 | 20160504 | 0 | |
| 126153791 | 12615379 | 16 | 20160308 | 20160309 | 0 | |
| 126153791 | 12615379 | 17 | 20160311 | 20160311 | 0 | |
| 126153791 | 12615379 | 18 | 20160314 | 20160314 | 0 |