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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125921221 | 12592122 | 1 | I | 201603 | 20160331 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2016-005408 | UNITED THERAPEUTICS | 51.48 | YR | F | Y | 72.56000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125921221 | 12592122 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 2.625 MG, TID | 2100476 | 203496 | 2.625 | MG | TABLET | TID | |||||
| 125921221 | 12592122 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 3.5 MG, TID | 2100679 | 203496 | 3.5 | MG | TABLET | TID | |||||
| 125921221 | 12592122 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | 2100684 | 203496 | TABLET | ||||||||
| 125921221 | 12592122 | 4 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | 2100477 | 203496 | TABLET | ||||||||
| 125921221 | 12592122 | 5 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | 2100476 | 203496 | TABLET | ||||||||
| 125921221 | 12592122 | 6 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 3.25MG,TID | 203496 | 3.25 | MG | TABLET | TID | ||||||
| 125921221 | 12592122 | 7 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 3.375MG, TID | 203496 | 3.375 | MG | TABLET | TID | ||||||
| 125921221 | 12592122 | 8 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125921221 | 12592122 | 1 | Pulmonary arterial hypertension |
| 125921221 | 12592122 | 2 | Pulmonary arterial hypertension |
| 125921221 | 12592122 | 8 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125921221 | 12592122 | Arthralgia | |
| 125921221 | 12592122 | Headache | |
| 125921221 | 12592122 | Myalgia | |
| 125921221 | 12592122 | Nasopharyngitis | |
| 125921221 | 12592122 | Pain in extremity | |
| 125921221 | 12592122 | Sinus congestion |
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 |
|---|---|---|---|---|---|---|
| 125921221 | 12592122 | 1 | 20151021 | 0 | ||
| 125921221 | 12592122 | 6 | 20160418 | 20160421 | 0 | |
| 125921221 | 12592122 | 7 | 20160422 | 0 | ||
| 125921221 | 12592122 | 8 | 201511 | 0 |