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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125700201 | 12570020 | 1 | I | 20160710 | 20160704 | 20160719 | 20160719 | EXP | US-UNITED THERAPEUTICS-UNT-2016-010832 | UNITED THERAPEUTICS | 50.47 | YR | F | Y | 48.53000 | KG | 20160719 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125700201 | 12570020 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.09 ?G/KG, CONTINUING | U | U | 2100909 | 21272 | .09 | UG/KG | INJECTION | ||||
| 125700201 | 12570020 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | UNK | U | U | 929005 | 21272 | INJECTION | |||||||
| 125700201 | 12570020 | 3 | C | TRACLEER | BOSENTAN | 1 | 0 | ||||||||||||
| 125700201 | 12570020 | 4 | C | COUMADIN | WARFARIN SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125700201 | 12570020 | 1 | Pulmonary arterial hypertension |
| 125700201 | 12570020 | 3 | Product used for unknown indication |
| 125700201 | 12570020 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125700201 | 12570020 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125700201 | 12570020 | Device related infection | |
| 125700201 | 12570020 | Injection site haemorrhage | |
| 125700201 | 12570020 | Injection site laceration | |
| 125700201 | 12570020 | Injection site pruritus |
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 |
|---|---|---|---|---|---|---|
| 125700201 | 12570020 | 1 | 20141021 | 0 |