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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116819417 | 11681941 | 7 | F | 20150517 | 20160824 | 20151029 | 20160830 | EXP | PHHO2015US015131 | SANDOZ | 77.33 | YR | M | Y | 109.75000 | KG | 20160830 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116819417 | 11681941 | 1 | SS | DIOVAN | VALSARTAN | 1 | Oral | CODE NOT BROKEN | 0 | TABLET | |||||||||
| 116819417 | 11681941 | 2 | SS | BLINDED LCZ696 | SACUBITRIL | 1 | Oral | CODE NOT BROKEN | 0 | TABLET | |||||||||
| 116819417 | 11681941 | 3 | SS | BLINDED NO TREATMENT RECEIVED | INVESTIGATIONAL PRODUCT | 1 | Oral | CODE NOT BROKEN | 0 | TABLET | |||||||||
| 116819417 | 11681941 | 4 | SS | VALSARTAN / DIOVAN / VAL489 / CGP 48933 | VALSARTAN | 1 | Oral | 80 MG, BID | 1120 | MG | 0 | 80 | MG | BID | |||||
| 116819417 | 11681941 | 5 | SS | VALSARTAN / DIOVAN / VAL489 / CGP 48933 | VALSARTAN | 1 | Oral | 80 MG, BID | 1120 | MG | 0 | 80 | MG | BID | |||||
| 116819417 | 11681941 | 6 | SS | VALSARTAN / DIOVAN / VAL489 / CGP 48933 | VALSARTAN | 1 | Oral | UNK | 1120 | MG | 0 | ||||||||
| 116819417 | 11681941 | 7 | SS | METOLAZONE. | METOLAZONE | 1 | Oral | 2.5 MG, QD | 2 | MG | Y | 0 | 2.5 | MG | QD | ||||
| 116819417 | 11681941 | 8 | PS | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 120 MG, BID | Y | 18569 | 120 | MG | BID | ||||||
| 116819417 | 11681941 | 9 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 160 MG, BID | Y | 18569 | 160 | MG | BID | ||||||
| 116819417 | 11681941 | 10 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 120 MG, BID | Y | 18569 | 120 | MG | BID | ||||||
| 116819417 | 11681941 | 11 | SS | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 25 MG, QD | 4550 | MG | Y | 0 | 25 | MG | QD | ||||
| 116819417 | 11681941 | 12 | SS | ISOSORBIDE MONONITRATE. | ISOSORBIDE MONONITRATE | 1 | Unknown | Y | 0 | ||||||||||
| 116819417 | 11681941 | 13 | C | LASIX | FUROSEMIDE | 1 | Unknown | Y | 0 | ||||||||||
| 116819417 | 11681941 | 14 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | Y | 0 | ||||||||||
| 116819417 | 11681941 | 15 | C | POTASSIUM | POTASSIUM | 1 | Unknown | Y | 0 | ||||||||||
| 116819417 | 11681941 | 16 | C | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Unknown | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116819417 | 11681941 | 1 | Cardiac failure chronic |
| 116819417 | 11681941 | 2 | Cardiac failure chronic |
| 116819417 | 11681941 | 3 | Cardiac failure chronic |
| 116819417 | 11681941 | 4 | Cardiac failure chronic |
| 116819417 | 11681941 | 7 | Fluid overload |
| 116819417 | 11681941 | 8 | Fluid overload |
| 116819417 | 11681941 | 11 | Fluid overload |
| 116819417 | 11681941 | 12 | Chest pain |
| 116819417 | 11681941 | 13 | Product used for unknown indication |
| 116819417 | 11681941 | 14 | Product used for unknown indication |
| 116819417 | 11681941 | 15 | Product used for unknown indication |
| 116819417 | 11681941 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116819417 | 11681941 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116819417 | 11681941 | Acute kidney injury | |
| 116819417 | 11681941 | Angina pectoris | |
| 116819417 | 11681941 | Bradycardia | |
| 116819417 | 11681941 | Cardiac disorder | |
| 116819417 | 11681941 | Cardiac failure | |
| 116819417 | 11681941 | Chest pain | |
| 116819417 | 11681941 | Hyperglycaemia | |
| 116819417 | 11681941 | Hyperkalaemia | |
| 116819417 | 11681941 | Hypotension |
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 |
|---|---|---|---|---|---|---|
| 116819417 | 11681941 | 1 | 20150716 | 20150928 | 0 | |
| 116819417 | 11681941 | 2 | 20150716 | 20150928 | 0 | |
| 116819417 | 11681941 | 3 | 20150716 | 20150928 | 0 | |
| 116819417 | 11681941 | 4 | 20150511 | 20150517 | 0 | |
| 116819417 | 11681941 | 5 | 20150528 | 0 | ||
| 116819417 | 11681941 | 6 | 20051118 | 0 | ||
| 116819417 | 11681941 | 7 | 20150514 | 20150514 | 0 | |
| 116819417 | 11681941 | 8 | 20081231 | 0 | ||
| 116819417 | 11681941 | 10 | 20150517 | 0 | ||
| 116819417 | 11681941 | 11 | 20141117 | 20150517 | 0 |