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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125948201 | 12594820 | 1 | I | 201603 | 20160303 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2016-003658 | UNITED THERAPEUTICS | 64.29 | YR | F | Y | 99.32000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125948201 | 12594820 | 1 | PS | TYVASO | TREPROSTINIL | 1 | 18-54 MICROGRAMS, QID | 2100747 | 22387 | INHALATION GAS | QID | ||||||||
| 125948201 | 12594820 | 2 | SS | TYVASO | TREPROSTINIL | 1 | UNK | 2100752 | 22387 | INHALATION GAS | |||||||||
| 125948201 | 12594820 | 3 | SS | TYVASO | TREPROSTINIL | 1 | 54 ?G, QID | 22387 | 54 | UG | INHALATION GAS | QID | |||||||
| 125948201 | 12594820 | 4 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | 10 MG, QD | 1500227A | 0 | 10 | MG | TABLET | QD | |||||
| 125948201 | 12594820 | 5 | C | ADCIRCA | TADALAFIL | 1 | U | U | 0 | ||||||||||
| 125948201 | 12594820 | 6 | C | COUMADIN | WARFARIN SODIUM | 1 | Unknown | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125948201 | 12594820 | 1 | Pulmonary arterial hypertension |
| 125948201 | 12594820 | 4 | Product used for unknown indication |
| 125948201 | 12594820 | 5 | Product used for unknown indication |
| 125948201 | 12594820 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125948201 | 12594820 | Dyspnoea | |
| 125948201 | 12594820 | Oropharyngeal pain | |
| 125948201 | 12594820 | Therapy cessation | |
| 125948201 | 12594820 | Throat irritation | |
| 125948201 | 12594820 | Treatment noncompliance |
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 |
|---|---|---|---|---|---|---|
| 125948201 | 12594820 | 1 | 20130401 | 0 | ||
| 125948201 | 12594820 | 3 | 20160328 | 0 | ||
| 125948201 | 12594820 | 4 | 20111214 | 0 |