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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125909231 | 12590923 | 1 | I | 201604 | 20160413 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2016-006165 | UNITED THERAPEUTICS | 73.74 | YR | F | Y | 83.45000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125909231 | 12590923 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | TOTAL 0.75 MG DAILY | 2100476 | 203496 | TABLET | ||||||||
| 125909231 | 12590923 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | UNK | 2100477 | 203496 | TABLET | |||||||||
| 125909231 | 12590923 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | UNK | 2100679 | 203496 | TABLET | |||||||||
| 125909231 | 12590923 | 4 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 6 MG, TID | 2100679 | 203496 | 6 | MG | TABLET | TID | |||||
| 125909231 | 12590923 | 5 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 8 MG, TID | 2100476 | 203496 | 8 | MG | TABLET | TID | |||||
| 125909231 | 12590923 | 6 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.03463 ?G/KG, CONTINUING | U | U | 2100701 | 0 | .034 | UG/KG | INJECTION | ||||
| 125909231 | 12590923 | 7 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.007 ?G/KG, CONTINUING | U | U | 2100701 | 0 | .007 | UG/KG | INJECTION | ||||
| 125909231 | 12590923 | 8 | C | ADCIRCA | TADALAFIL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125909231 | 12590923 | 1 | Pulmonary arterial hypertension |
| 125909231 | 12590923 | 6 | Pulmonary arterial hypertension |
| 125909231 | 12590923 | 8 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125909231 | 12590923 | Dizziness | |
| 125909231 | 12590923 | Headache | |
| 125909231 | 12590923 | Hypotension | |
| 125909231 | 12590923 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 125909231 | 12590923 | 1 | 20160321 | 0 | ||
| 125909231 | 12590923 | 5 | 20160321 | 0 | ||
| 125909231 | 12590923 | 6 | 20140513 | 20160418 | 0 |