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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125996461 | 12599646 | 1 | I | 20160519 | 20160520 | 20160727 | 20160727 | EXP | PHHO2016GB007511 | SANDOZ | 82.80 | YR | M | Y | 78.00000 | KG | 20160727 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125996461 | 12599646 | 1 | SS | BLINDED NO TREATMENT RECEIVED | INVESTIGATIONAL PRODUCT | 1 | Intravenous (not otherwise specified) | CODE NOT BROKEN | 0 | INJECTION | |||||||||
| 125996461 | 12599646 | 2 | SS | BLINDED PLACEBO | INVESTIGATIONAL PRODUCT | 1 | Intravenous (not otherwise specified) | CODE NOT BROKEN | 0 | INJECTION | |||||||||
| 125996461 | 12599646 | 3 | SS | BLINDED RLX030 | SERELAXIN | 1 | Intravenous (not otherwise specified) | CODE NOT BROKEN | 0 | INJECTION | |||||||||
| 125996461 | 12599646 | 4 | PS | FUROSEMIDE. | FUROSEMIDE | 1 | Intravenous (not otherwise specified) | 40 MG, BID | 80 | MG | 18569 | 40 | MG | BID | |||||
| 125996461 | 12599646 | 5 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Unknown | 240 MG, OVER 24 HRS | 80 | MG | 18569 | 240 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125996461 | 12599646 | 1 | Cardiac failure acute |
| 125996461 | 12599646 | 2 | Cardiac failure acute |
| 125996461 | 12599646 | 3 | Cardiac failure acute |
| 125996461 | 12599646 | 4 | Diuretic therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125996461 | 12599646 | OT |
| 125996461 | 12599646 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125996461 | 12599646 | Acute kidney injury | |
| 125996461 | 12599646 | Cardiac failure |
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 |
|---|---|---|---|---|---|---|
| 125996461 | 12599646 | 1 | 20160516 | 20160518 | 0 | |
| 125996461 | 12599646 | 2 | 20160516 | 20160518 | 0 | |
| 125996461 | 12599646 | 3 | 20160516 | 20160518 | 0 | |
| 125996461 | 12599646 | 4 | 20160516 | 20160516 | 0 | |
| 125996461 | 12599646 | 5 | 20160523 | 20160525 | 0 |