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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125912572 | 12591257 | 2 | F | 201512 | 20151230 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2015-016182 | UNITED THERAPEUTICS | 64.02 | YR | M | Y | 108.84000 | KG | 20160726 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125912572 | 12591257 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.02 ?G/KG, CONTINUING | U | U | 926118 | 21272 | .02 | UG/KG | INJECTION | ||||
| 125912572 | 12591257 | 2 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | 5 MG,QD | NZYD | 0 | 5 | MG | TABLET | QD | |||||
| 125912572 | 12591257 | 3 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | 10 MG,QD | SBFT | 0 | 10 | MG | TABLET | QD | |||||
| 125912572 | 12591257 | 4 | SS | REVATIO | SILDENAFIL CITRATE | 1 | Unknown | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125912572 | 12591257 | 1 | Pulmonary hypertension |
| 125912572 | 12591257 | 2 | Product used for unknown indication |
| 125912572 | 12591257 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125912572 | 12591257 | Infusion site irritation | |
| 125912572 | 12591257 | Infusion site oedema | |
| 125912572 | 12591257 | Infusion site pruritus | |
| 125912572 | 12591257 | Infusion site vesicles | |
| 125912572 | 12591257 | Oedema peripheral |
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 |
|---|---|---|---|---|---|---|
| 125912572 | 12591257 | 1 | 20140311 | 0 | ||
| 125912572 | 12591257 | 2 | 20151109 | 0 | ||
| 125912572 | 12591257 | 3 | 20121116 | 0 |