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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125921141 | 12592114 | 1 | I | 201601 | 20160112 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2016-003462 | UNITED THERAPEUTICS | 69.44 | YR | F | Y | 117.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125921141 | 12592114 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.008 ?G/KG/MIN | 21272 | .008 | UG/KG | INJECTION | |||||||
| 125921141 | 12592114 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.006 ?G/KG, UNK | 21272 | .006 | UG/KG | INJECTION | |||||||
| 125921141 | 12592114 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.004 ?G/KG, UNK | 21272 | .004 | UG/KG | INJECTION | |||||||
| 125921141 | 12592114 | 4 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Unknown | 10 MG, QD | SBFT | 0 | 10 | MG | TABLET | QD | |||||
| 125921141 | 12592114 | 5 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Unknown | UNK | 1500225A | 0 | TABLET | ||||||||
| 125921141 | 12592114 | 6 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Unknown | 75 MG, BID | 0 | 75 | MG | BID | |||||||
| 125921141 | 12592114 | 7 | SS | REVATIO | SILDENAFIL CITRATE | 1 | Unknown | UNK | N | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125921141 | 12592114 | 1 | Pulmonary arterial hypertension |
| 125921141 | 12592114 | 4 | Pulmonary arterial hypertension |
| 125921141 | 12592114 | 6 | Product used for unknown indication |
| 125921141 | 12592114 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125921141 | 12592114 | Fatigue | |
| 125921141 | 12592114 | Hypotension | |
| 125921141 | 12592114 | Oedema peripheral | |
| 125921141 | 12592114 | Skin infection | |
| 125921141 | 12592114 | Skin lesion |
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 |
|---|---|---|---|---|---|---|
| 125921141 | 12592114 | 1 | 20151214 | 0 | ||
| 125921141 | 12592114 | 4 | 20140730 | 0 | ||
| 125921141 | 12592114 | 7 | 20140118 | 201408 | 0 |