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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123935335 | 12393533 | 5 | F | 20160407 | 20160816 | 20160523 | 20160823 | EXP | JP-OTSUKA-2016_008412 | OTSUKA | 73.85 | YR | M | Y | 0.00000 | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123935335 | 12393533 | 1 | PS | SAMSCA | TOLVAPTAN | 1 | Oral | 3.75 MG, DAILY DOSE | Y | N | 22275 | 3.75 | MG | TABLET | |||||
| 123935335 | 12393533 | 2 | SS | SAMSCA | TOLVAPTAN | 1 | Unknown | UNK | Y | N | 22275 | TABLET | |||||||
| 123935335 | 12393533 | 3 | SS | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 25 MG, DAILY DOSE | Y | 0 | 25 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123935335 | 12393533 | 1 | Ascites |
| 123935335 | 12393533 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123935335 | 12393533 | OT |
| 123935335 | 12393533 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123935335 | 12393533 | Blood pressure decreased | |
| 123935335 | 12393533 | Bradycardia | |
| 123935335 | 12393533 | Dehydration | |
| 123935335 | 12393533 | Dizziness | |
| 123935335 | 12393533 | Hyperkalaemia | |
| 123935335 | 12393533 | Ischaemic hepatitis |
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 |
|---|---|---|---|---|---|---|
| 123935335 | 12393533 | 1 | 20160326 | 20160407 | 0 | |
| 123935335 | 12393533 | 2 | 20160509 | 0 | ||
| 123935335 | 12393533 | 3 | 20160326 | 20160407 | 0 |