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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125917551 | 12591755 | 1 | I | 201601 | 20160123 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2016-001189 | UNITED THERAPEUTICS | 3.47 | YR | F | Y | 13.20000 | KG | 20160726 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125917551 | 12591755 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Intravenous (not otherwise specified) | 0.06 ?G/KG, CONTINUING | 2100498 | 21272 | .06 | UG/KG | INJECTION | ||||||
| 125917551 | 12591755 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | UNK | 21272 | INJECTION | ||||||||||
| 125917551 | 12591755 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 0.014 ?G/KG, CONTINUING | U | U | T241 | 0 | .014 | UG/KG | INFUSION | |||||
| 125917551 | 12591755 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 0.038 ?G/KG, CONTINUING | U | U | V049 | 0 | .038 | UG/KG | INFUSION | |||||
| 125917551 | 12591755 | 5 | C | TRACLEER | BOSENTAN | 1 | U | U | 0 | ||||||||||
| 125917551 | 12591755 | 6 | C | SILDENAFIL. | SILDENAFIL | 1 | Oral | 10 MG, Q8H | U | U | 0 | 10 | MG | TID | |||||
| 125917551 | 12591755 | 7 | C | BOSENTAN. | BOSENTAN | 1 | Oral | 31.2 MG, Q12H | U | U | 0 | 31.2 | MG | BID | |||||
| 125917551 | 12591755 | 8 | C | ASA | ASPIRIN | 1 | Oral | 81 MG, QD | U | U | 0 | 81 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125917551 | 12591755 | 1 | Pulmonary arterial hypertension |
| 125917551 | 12591755 | 3 | Pulmonary arterial hypertension |
| 125917551 | 12591755 | 5 | Product used for unknown indication |
| 125917551 | 12591755 | 6 | Product used for unknown indication |
| 125917551 | 12591755 | 7 | Product used for unknown indication |
| 125917551 | 12591755 | 8 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125917551 | 12591755 | Drug effect delayed | |
| 125917551 | 12591755 | Flushing | |
| 125917551 | 12591755 | Oxygen saturation decreased |
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 |
|---|---|---|---|---|---|---|
| 125917551 | 12591755 | 1 | 20160123 | 0 | ||
| 125917551 | 12591755 | 3 | 20151123 | 0 |