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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126157881 | 12615788 | 1 | I | 20160719 | 20160721 | 20160802 | 20160802 | EXP | PHHO2016US010642 | SANDOZ | 95.66 | YR | M | Y | 76.20000 | KG | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126157881 | 12615788 | 1 | PS | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 4 DF, BID | 18569 | 4 | DF | BID | |||||||
| 126157881 | 12615788 | 2 | SS | BLINDED NO TREATMENT RECEIVED | INVESTIGATIONAL PRODUCT | 1 | Intravenous (not otherwise specified) | CODE NOT BROKEN | 0 | INJECTION | |||||||||
| 126157881 | 12615788 | 3 | SS | BLINDED PLACEBO | INVESTIGATIONAL PRODUCT | 1 | Intravenous (not otherwise specified) | CODE NOT BROKEN | 0 | INJECTION | |||||||||
| 126157881 | 12615788 | 4 | SS | BLINDED RLX030 | SERELAXIN | 1 | Intravenous (not otherwise specified) | CODE NOT BROKEN | 0 | INJECTION | |||||||||
| 126157881 | 12615788 | 5 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 81 MG, QD | 0 | 81 | MG | TABLET | QD | ||||||
| 126157881 | 12615788 | 6 | C | DOCUSATE SODIUM. | DOCUSATE SODIUM | 1 | Oral | 100 MG, BID (AS NEEDED) | 9000 | MG | 0 | 100 | MG | CAPSULE | BID | ||||
| 126157881 | 12615788 | 7 | C | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | Oral | 20 MG, (EVERY MORNING) | 0 | 20 | MG | ||||||||
| 126157881 | 12615788 | 8 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Oral | 10 MG,(EVERY MORNING) | 0 | 10 | MG | ||||||||
| 126157881 | 12615788 | 9 | C | METOPROLOL TARTRATE. | METOPROLOL TARTRATE | 1 | Oral | 37.5 MG, BID | 3375 | MG | 0 | 37.5 | MG | BID | |||||
| 126157881 | 12615788 | 10 | C | METOPROLOL TARTRATE. | METOPROLOL TARTRATE | 1 | 3375 | MG | 0 | ||||||||||
| 126157881 | 12615788 | 11 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 10 MG (NIGHT) | 0 | 10 | MG | ||||||||
| 126157881 | 12615788 | 12 | C | TAMSULOSIN | TAMSULOSIN | 1 | Oral | 0.4 MG, QD | 18 | MG | 0 | .4 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126157881 | 12615788 | 1 | Cardiac failure congestive |
| 126157881 | 12615788 | 2 | Cardiac failure acute |
| 126157881 | 12615788 | 3 | Cardiac failure acute |
| 126157881 | 12615788 | 4 | Cardiac failure acute |
| 126157881 | 12615788 | 5 | Prophylaxis |
| 126157881 | 12615788 | 6 | Constipation prophylaxis |
| 126157881 | 12615788 | 7 | Gastrooesophageal reflux disease |
| 126157881 | 12615788 | 8 | Adrenal insufficiency |
| 126157881 | 12615788 | 9 | Hypertension |
| 126157881 | 12615788 | 10 | Atrial fibrillation |
| 126157881 | 12615788 | 11 | Hyperlipidaemia |
| 126157881 | 12615788 | 12 | Benign prostatic hyperplasia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126157881 | 12615788 | HO |
| 126157881 | 12615788 | OT |
| 126157881 | 12615788 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126157881 | 12615788 | Cardiac failure | |
| 126157881 | 12615788 | Pleural effusion | |
| 126157881 | 12615788 | Renal impairment |
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 |
|---|---|---|---|---|---|---|
| 126157881 | 12615788 | 1 | 20160612 | 20160719 | 0 | |
| 126157881 | 12615788 | 2 | 20160707 | 20160709 | 0 | |
| 126157881 | 12615788 | 3 | 20160707 | 20160709 | 0 | |
| 126157881 | 12615788 | 4 | 20160707 | 20160709 | 0 | |
| 126157881 | 12615788 | 5 | 2013 | 20160719 | 0 | |
| 126157881 | 12615788 | 6 | 20160605 | 20160719 | 0 | |
| 126157881 | 12615788 | 7 | 1991 | 20160719 | 0 | |
| 126157881 | 12615788 | 8 | 20160605 | 20160719 | 0 | |
| 126157881 | 12615788 | 9 | 20160605 | 20160719 | 0 | |
| 126157881 | 12615788 | 11 | 2001 | 20160719 | 0 | |
| 126157881 | 12615788 | 12 | 20160605 | 20160719 | 0 |