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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118469252 | 11846925 | 2 | F | 20151109 | 20160203 | 20151217 | 20160210 | EXP | US-UNITED THERAPEUTICS-UNT-2015-014346 | UNITED THERAPEUTICS | 0.00 | A | F | Y | 0.00000 | 20160210 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118469252 | 11846925 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.625 MG, BID | 203496 | .625 | MG | TABLET | BID | ||||||
| 118469252 | 11846925 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.875 MG, TID | 203496 | .875 | MG | TABLET | TID | ||||||
| 118469252 | 11846925 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 1 MG, TID | 203496 | 1 | MG | TABLET | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118469252 | 11846925 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118469252 | 11846925 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118469252 | 11846925 | Dizziness | |
| 118469252 | 11846925 | Fall | |
| 118469252 | 11846925 | Headache | |
| 118469252 | 11846925 | Pain in extremity |
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 |
|---|---|---|---|---|---|---|
| 118469252 | 11846925 | 1 | 20150921 | 0 | ||
| 118469252 | 11846925 | 3 | 20151014 | 0 |