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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125538301 | 12553830 | 1 | I | 20160606 | 20160701 | 20160713 | 20160713 | EXP | BX20161085 | FR-VALIDUS PHARMACEUTICALS LLC-FR-2016VAL002264 | VALIDUS | 73.00 | YR | F | Y | 0.00000 | 20160713 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125538301 | 12553830 | 1 | PS | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 20 MG, DAILY | Y | 16273 | 20 | MG | TABLET | ||||||
| 125538301 | 12553830 | 2 | SS | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | Oral | 60 MG, DAILY | Y | 0 | 60 | MG | |||||||
| 125538301 | 12553830 | 3 | SS | COZAAR | LOSARTAN POTASSIUM | 1 | 50 MG, TWICE A DAY | Y | 0 | 50 | MG | ||||||||
| 125538301 | 12553830 | 4 | SS | ALDACTONE | SPIRONOLACTONE | 1 | Oral | 25 MG, DAILY | Y | 0 | 25 | MG | COATED TABLET | ||||||
| 125538301 | 12553830 | 5 | SS | TEMESTA /00273201/ | LORAZEPAM | 1 | Oral | 1 MG, UNK | Y | 0 | 1 | MG | |||||||
| 125538301 | 12553830 | 6 | SS | TEMESTA /00273201/ | LORAZEPAM | 1 | Oral | UNK | Y | 0 | |||||||||
| 125538301 | 12553830 | 7 | C | ZOPICLONE | ZOPICLONE | 1 | UNK | U | 0 | ||||||||||
| 125538301 | 12553830 | 8 | C | TAHOR | ATORVASTATIN CALCIUM | 1 | UNK | U | 0 | ||||||||||
| 125538301 | 12553830 | 9 | C | SOTALEX | SOTALOL | 1 | UNK | U | 0 | ||||||||||
| 125538301 | 12553830 | 10 | C | DIFFU K | POTASSIUM CHLORIDE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125538301 | 12553830 | 1 | Product used for unknown indication |
| 125538301 | 12553830 | 2 | Product used for unknown indication |
| 125538301 | 12553830 | 3 | Product used for unknown indication |
| 125538301 | 12553830 | 4 | Product used for unknown indication |
| 125538301 | 12553830 | 5 | Product used for unknown indication |
| 125538301 | 12553830 | 7 | Product used for unknown indication |
| 125538301 | 12553830 | 8 | Product used for unknown indication |
| 125538301 | 12553830 | 9 | Product used for unknown indication |
| 125538301 | 12553830 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125538301 | 12553830 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125538301 | 12553830 | Hyponatraemia | |
| 125538301 | 12553830 | Status epilepticus |
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 |
|---|---|---|---|---|---|---|
| 125538301 | 12553830 | 1 | 20160607 | 0 | ||
| 125538301 | 12553830 | 2 | 20160607 | 0 | ||
| 125538301 | 12553830 | 3 | 20160607 | 0 | ||
| 125538301 | 12553830 | 4 | 20160607 | 0 | ||
| 125538301 | 12553830 | 5 | 20160607 | 0 |