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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125658692 | 12565869 | 2 | F | 20160612 | 20160812 | 20160718 | 20160819 | EXP | PHEH2016US017109 | NOVARTIS | 76.67 | YR | M | Y | 66.20000 | KG | 20160819 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125658692 | 12565869 | 1 | PS | ENTRESTO | SACUBITRILVALSARTAN | 1 | Oral | 50 MG, BID | U | 207620 | 50 | MG | BID | ||||||
| 125658692 | 12565869 | 2 | SS | ZAROXOLYN | METOLAZONE | 1 | Oral | 2.5 MG, QW, PRN (AS NEEDED) | U | 0 | 2.5 | MG | /wk | ||||||
| 125658692 | 12565869 | 3 | SS | ZAROXOLYN | METOLAZONE | 1 | U | 0 | |||||||||||
| 125658692 | 12565869 | 4 | SS | TORSEMIDE. | TORSEMIDE | 1 | Oral | 40 MG, BID | U | 0 | 40 | MG | BID | ||||||
| 125658692 | 12565869 | 5 | C | ALDACTONE | SPIRONOLACTONE | 1 | Oral | 25 MG, QD | U | 0 | 25 | MG | QD | ||||||
| 125658692 | 12565869 | 6 | C | COREG | CARVEDILOL | 1 | Oral | 12.5 MG, BID | U | 0 | 12.5 | MG | BID | ||||||
| 125658692 | 12565869 | 7 | C | DIGOXIN. | DIGOXIN | 1 | Oral | 125 MG, QD | U | 0 | 125 | MG | QD | ||||||
| 125658692 | 12565869 | 8 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Oral | 75 MG, QD | U | 0 | 75 | MG | QD | ||||||
| 125658692 | 12565869 | 9 | C | RANEXA | RANOLAZINE | 1 | Oral | 500 MG, BID | 0 | 500 | MG | BID | |||||||
| 125658692 | 12565869 | 10 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 175 UG, QD | U | 0 | 175 | UG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125658692 | 12565869 | 1 | Left ventricular failure |
| 125658692 | 12565869 | 2 | Weight increased |
| 125658692 | 12565869 | 3 | Left ventricular failure |
| 125658692 | 12565869 | 4 | Left ventricular failure |
| 125658692 | 12565869 | 5 | Left ventricular failure |
| 125658692 | 12565869 | 6 | Left ventricular failure |
| 125658692 | 12565869 | 7 | Left ventricular failure |
| 125658692 | 12565869 | 8 | Coronary artery disease |
| 125658692 | 12565869 | 9 | Coronary artery disease |
| 125658692 | 12565869 | 10 | Hypothyroidism |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125658692 | 12565869 | OT |
| 125658692 | 12565869 | HO |
| 125658692 | 12565869 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125658692 | 12565869 | Arrhythmia | |
| 125658692 | 12565869 | Blood chloride decreased | |
| 125658692 | 12565869 | Blood sodium decreased | |
| 125658692 | 12565869 | Brain natriuretic peptide increased | |
| 125658692 | 12565869 | Cardio-respiratory distress | |
| 125658692 | 12565869 | Dehydration | |
| 125658692 | 12565869 | Device malfunction | |
| 125658692 | 12565869 | Dizziness | |
| 125658692 | 12565869 | Hypokalaemia | |
| 125658692 | 12565869 | Loss of consciousness | |
| 125658692 | 12565869 | Pleural effusion | |
| 125658692 | 12565869 | Pneumonia | |
| 125658692 | 12565869 | Urinary tract infection | |
| 125658692 | 12565869 | Ventricular tachycardia | |
| 125658692 | 12565869 | 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 |
|---|---|---|---|---|---|---|
| 125658692 | 12565869 | 1 | 201601 | 0 |