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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125954011 | 12595401 | 1 | I | 201604 | 20160402 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2016-005543 | UNITED THERAPEUTICS | 13.31 | YR | M | Y | 43.54000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125954011 | 12595401 | 1 | PS | TYVASO | TREPROSTINIL | 1 | 18-54 MICROGRAMS, QID | Y | 2100598 | 22387 | INHALATION GAS | QID | |||||||
| 125954011 | 12595401 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 2 MG, Q12H | Y | 2100477 | 0 | 2 | MG | TABLET | BID | ||||
| 125954011 | 12595401 | 3 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | 10 MG, QD | 1500227A | 0 | 10 | MG | QD | ||||||
| 125954011 | 12595401 | 4 | C | ADCIRCA | TADALAFIL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125954011 | 12595401 | 1 | Pulmonary hypertension |
| 125954011 | 12595401 | 2 | Pulmonary hypertension |
| 125954011 | 12595401 | 3 | Product used for unknown indication |
| 125954011 | 12595401 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125954011 | 12595401 | Chest pain | |
| 125954011 | 12595401 | Cough | |
| 125954011 | 12595401 | Throat irritation |
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 |
|---|---|---|---|---|---|---|
| 125954011 | 12595401 | 1 | 20160329 | 0 | ||
| 125954011 | 12595401 | 2 | 20141104 | 0 | ||
| 125954011 | 12595401 | 3 | 20131007 | 0 |