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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125022092 | 12502209 | 2 | F | 20160616 | 20160628 | 20160627 | 20160706 | EXP | PHHO2016SK008941 | SANDOZ | 92.65 | YR | F | Y | 58.00000 | KG | 20160706 | MD | SK | SK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125022092 | 12502209 | 1 | PS | RAMIPRIL. | RAMIPRIL | 1 | Oral | 2.5 MG, UNK | 77514 | 2.5 | MG | ||||||||
| 125022092 | 12502209 | 2 | SS | BLINDED NO TREATMENT RECEIVED | INVESTIGATIONAL PRODUCT | 1 | Intravenous (not otherwise specified) | CODE NOT BROKEN | 0 | ||||||||||
| 125022092 | 12502209 | 3 | SS | BLINDED PLACEBO | INVESTIGATIONAL PRODUCT | 1 | Intravenous (not otherwise specified) | CODE NOT BROKEN | 0 | ||||||||||
| 125022092 | 12502209 | 4 | SS | BLINDED RLX030 | SERELAXIN | 1 | Intravenous (not otherwise specified) | CODE NOT BROKEN | 0 | ||||||||||
| 125022092 | 12502209 | 5 | SS | BLINDED NO TREATMENT RECEIVED | INVESTIGATIONAL PRODUCT | 1 | Intravenous (not otherwise specified) | CODE NOT BROKEN | 0 | ||||||||||
| 125022092 | 12502209 | 6 | SS | BLINDED PLACEBO | INVESTIGATIONAL PRODUCT | 1 | Intravenous (not otherwise specified) | CODE NOT BROKEN | 0 | ||||||||||
| 125022092 | 12502209 | 7 | SS | BLINDED RLX030 | SERELAXIN | 1 | Intravenous (not otherwise specified) | CODE NOT BROKEN | 0 | ||||||||||
| 125022092 | 12502209 | 8 | SS | AMLODIPIN | AMLODIPINE BESYLATE | 1 | Oral | 5 MG, UNK | 0 | 5 | MG | ||||||||
| 125022092 | 12502209 | 9 | C | VEROSPIRON | SPIRONOLACTONE | 1 | Oral | 25 MG, UNK | 0 | 25 | MG | ||||||||
| 125022092 | 12502209 | 10 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 25 MG, UNK | 0 | 25 | MG | ||||||||
| 125022092 | 12502209 | 11 | C | BISOPROLOL | BISOPROLOL | 1 | Oral | 25 MG, UNK | 0 | 25 | MG | ||||||||
| 125022092 | 12502209 | 12 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 20 MG, UNK | 0 | 20 | MG | ||||||||
| 125022092 | 12502209 | 13 | C | CONCOR | BISOPROLOL FUMARATE | 1 | Unknown | 2.5 MG, UNK | 0 | 2.5 | MG | ||||||||
| 125022092 | 12502209 | 14 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 40 MG, UNK | 0 | 40 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125022092 | 12502209 | 1 | Cardiac failure |
| 125022092 | 12502209 | 2 | Cardiac failure acute |
| 125022092 | 12502209 | 3 | Cardiac failure acute |
| 125022092 | 12502209 | 4 | Cardiac failure acute |
| 125022092 | 12502209 | 8 | Hypertension |
| 125022092 | 12502209 | 9 | Cardiac failure |
| 125022092 | 12502209 | 10 | Cardiac failure |
| 125022092 | 12502209 | 11 | Cardiac failure |
| 125022092 | 12502209 | 12 | Prophylaxis |
| 125022092 | 12502209 | 13 | Cardiac failure |
| 125022092 | 12502209 | 14 | Cardiac failure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125022092 | 12502209 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125022092 | 12502209 | Circulatory collapse | |
| 125022092 | 12502209 | Dehydration | |
| 125022092 | 12502209 | 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 |
|---|---|---|---|---|---|---|
| 125022092 | 12502209 | 1 | 20160607 | 20160616 | 0 | |
| 125022092 | 12502209 | 2 | 20160608 | 20160608 | 0 | |
| 125022092 | 12502209 | 3 | 20160608 | 20160608 | 0 | |
| 125022092 | 12502209 | 4 | 20160608 | 20160608 | 0 | |
| 125022092 | 12502209 | 5 | 20160610 | 20160610 | 0 | |
| 125022092 | 12502209 | 6 | 20160610 | 20160610 | 0 | |
| 125022092 | 12502209 | 7 | 20160610 | 20160610 | 0 | |
| 125022092 | 12502209 | 8 | 20160616 | 0 | ||
| 125022092 | 12502209 | 9 | 20160607 | 0 | ||
| 125022092 | 12502209 | 10 | 20160609 | 0 | ||
| 125022092 | 12502209 | 11 | 20160609 | 0 | ||
| 125022092 | 12502209 | 13 | 20160609 | 0 | ||
| 125022092 | 12502209 | 14 | 20160609 | 0 |