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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125951011 | 12595101 | 1 | I | 201512 | 20151229 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2015-016600 | UNITED THERAPEUTICS | 12.36 | YR | F | Y | 30.20000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125951011 | 12595101 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 1 MG, BID | Y | 2100369 | 203496 | 1 | MG | TABLET | BID | ||||
| 125951011 | 12595101 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 3 MG, Q12H | Y | 2100369 | 203496 | 3 | MG | TABLET | BID | ||||
| 125951011 | 12595101 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 3 MG, BID | Y | 2100369 | 203496 | 3 | MG | TABLET | BID | ||||
| 125951011 | 12595101 | 4 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.25 MG, BID | Y | 203496 | .25 | MG | TABLET | BID | |||||
| 125951011 | 12595101 | 5 | SS | TYVASO | TREPROSTINIL | 1 | 60 ?G, QID | 2100699 | 0 | 60 | UG | INHALATION GAS | QID | ||||||
| 125951011 | 12595101 | 6 | SS | TYVASO | TREPROSTINIL | 1 | UNK | 2100705 | 0 | INHALATION GAS | |||||||||
| 125951011 | 12595101 | 7 | SS | TYVASO | TREPROSTINIL | 1 | UNK | 2100747 | 0 | INHALATION GAS | |||||||||
| 125951011 | 12595101 | 8 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | 10 MG, QD | U | U | SBFW | 0 | 10 | MG | TABLET | QD | |||
| 125951011 | 12595101 | 9 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | UNK | U | U | SBFT | 0 | TABLET | ||||||
| 125951011 | 12595101 | 10 | SS | REVATIO | SILDENAFIL CITRATE | 1 | Unknown | 20 MG, TID | 0 | 20 | MG | TID | |||||||
| 125951011 | 12595101 | 11 | C | DIGOXIN. | DIGOXIN | 1 | U | 0 | |||||||||||
| 125951011 | 12595101 | 12 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | 2 MG, BID | U | 0 | 2 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125951011 | 12595101 | 1 | Pulmonary arterial hypertension |
| 125951011 | 12595101 | 2 | Pulmonary arterial hypertension |
| 125951011 | 12595101 | 5 | Pulmonary arterial hypertension |
| 125951011 | 12595101 | 8 | Pulmonary arterial hypertension |
| 125951011 | 12595101 | 10 | Pulmonary arterial hypertension |
| 125951011 | 12595101 | 11 | Product used for unknown indication |
| 125951011 | 12595101 | 12 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125951011 | 12595101 | Abdominal discomfort | |
| 125951011 | 12595101 | Decreased appetite | |
| 125951011 | 12595101 | Depression | |
| 125951011 | 12595101 | Dyspepsia | |
| 125951011 | 12595101 | Dyspnoea | |
| 125951011 | 12595101 | Nausea | |
| 125951011 | 12595101 | Oedema | |
| 125951011 | 12595101 | Phobia | |
| 125951011 | 12595101 | Product use issue | |
| 125951011 | 12595101 | Skin irritation | |
| 125951011 | 12595101 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125951011 | 12595101 | 1 | 20151112 | 20160208 | 0 | |
| 125951011 | 12595101 | 4 | 20151117 | 20160214 | 0 | |
| 125951011 | 12595101 | 5 | 20110617 | 0 | ||
| 125951011 | 12595101 | 8 | 20100226 | 0 |