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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124546085 | 12454608 | 5 | F | 2016 | 20160720 | 20160610 | 20160727 | EXP | US-UNITED THERAPEUTICS-UNT-2016-006858 | UNITED THERAPEUTICS | 43.59 | YR | F | Y | 65.31000 | KG | 20160727 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124546085 | 12454608 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.020 ?G/KG, CONTINUING | Y | 926618 | 21272 | .02 | UG/KG | INJECTION | |||||
| 124546085 | 12454608 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.002 ?G/KG, CONTINUING | Y | 21272 | .002 | UG/KG | INJECTION | ||||||
| 124546085 | 12454608 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.014 ?G/KG, CONTINUING | Y | 21272 | .014 | UG/KG | INJECTION | ||||||
| 124546085 | 12454608 | 4 | SS | LASIX | FUROSEMIDE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124546085 | 12454608 | 5 | SS | LASIX | FUROSEMIDE | 1 | U | U | 0 | ||||||||||
| 124546085 | 12454608 | 6 | SS | METOLAZONE. | METOLAZONE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124546085 | 12454608 | 7 | SS | METOLAZONE. | METOLAZONE | 1 | U | U | 0 | ||||||||||
| 124546085 | 12454608 | 8 | C | WARFARIN | WARFARIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124546085 | 12454608 | 1 | Pulmonary arterial hypertension |
| 124546085 | 12454608 | 4 | Oedema |
| 124546085 | 12454608 | 5 | Fluid retention |
| 124546085 | 12454608 | 6 | Oedema |
| 124546085 | 12454608 | 7 | Fluid retention |
| 124546085 | 12454608 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124546085 | 12454608 | OT |
| 124546085 | 12454608 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124546085 | 12454608 | Abdominal distension | |
| 124546085 | 12454608 | Ascites | |
| 124546085 | 12454608 | Blood potassium decreased | |
| 124546085 | 12454608 | Cardiac failure congestive | |
| 124546085 | 12454608 | Electrolyte imbalance | |
| 124546085 | 12454608 | Intestinal obstruction | |
| 124546085 | 12454608 | Localised oedema | |
| 124546085 | 12454608 | Lung disorder | |
| 124546085 | 12454608 | Oedema | |
| 124546085 | 12454608 | Pulmonary arterial hypertension |
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 |
|---|---|---|---|---|---|---|
| 124546085 | 12454608 | 1 | 20160318 | 0 |