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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125950621 | 12595062 | 1 | I | 201601 | 20160106 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2016-000282 | UNITED THERAPEUTICS | 49.31 | YR | M | Y | 122.45000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125950621 | 12595062 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.25 MG, Q8H | U | U | 2100397 | 203496 | .25 | MG | TABLET | TID | |||
| 125950621 | 12595062 | 2 | SS | TYVASO | TREPROSTINIL | 1 | 18-54 MICROGRAMS, QID | 2100699 | 0 | INHALATION GAS | QID | ||||||||
| 125950621 | 12595062 | 3 | SS | TYVASO | TREPROSTINIL | 1 | UNK | 2100716 | 0 | INHALATION GAS | |||||||||
| 125950621 | 12595062 | 4 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | 10 MG, QD | 1500226A | 0 | 10 | MG | TABLET | QD | |||||
| 125950621 | 12595062 | 5 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | UNK | 1500225A | 0 | TABLET | ||||||||
| 125950621 | 12595062 | 6 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125950621 | 12595062 | 1 | Pulmonary hypertension |
| 125950621 | 12595062 | 2 | Pulmonary hypertension |
| 125950621 | 12595062 | 4 | Product used for unknown indication |
| 125950621 | 12595062 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125950621 | 12595062 | Abdominal pain upper | |
| 125950621 | 12595062 | Depressed mood | |
| 125950621 | 12595062 | Device issue | |
| 125950621 | 12595062 | Diarrhoea | |
| 125950621 | 12595062 | Dyspnoea | |
| 125950621 | 12595062 | Fatigue | |
| 125950621 | 12595062 | Headache | |
| 125950621 | 12595062 | Hypersomnia | |
| 125950621 | 12595062 | Incorrect dose administered | |
| 125950621 | 12595062 | Malaise | |
| 125950621 | 12595062 | Palpitations | |
| 125950621 | 12595062 | Parosmia | |
| 125950621 | 12595062 | Therapy cessation |
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 |
|---|---|---|---|---|---|---|
| 125950621 | 12595062 | 1 | 20160108 | 0 | ||
| 125950621 | 12595062 | 2 | 20140429 | 0 | ||
| 125950621 | 12595062 | 4 | 20111201 | 0 |