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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125944651 | 12594465 | 1 | I | 201511 | 20151127 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2015-015159 | UNITED THERAPEUTICS | 73.19 | YR | F | Y | 66.67000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125944651 | 12594465 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 1.75 MG, BID | U | U | 2100398 | 203496 | 1.75 | MG | TABLET | BID | |||
| 125944651 | 12594465 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | UNK | U | U | 2100397 | 203496 | TABLET | |||||||
| 125944651 | 12594465 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 2.5 MG, Q12H | U | U | 203496 | 2.5 | MG | TABLET | BID | ||||
| 125944651 | 12594465 | 4 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 2.75 MG, BID | U | U | 2100397 | 203496 | 2.75 | MG | TABLET | BID | |||
| 125944651 | 12594465 | 5 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | U | U | 2100398 | 203496 | TABLET | ||||||
| 125944651 | 12594465 | 6 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | U | U | 2100399 | 203496 | TABLET | ||||||
| 125944651 | 12594465 | 7 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 4 MG, BID | U | U | 2100397 | 203496 | 4 | MG | TABLET | BID | |||
| 125944651 | 12594465 | 8 | SS | ORENITRAM | TREPROSTINIL | 1 | UNK | U | U | 2100679 | 203496 | TABLET | |||||||
| 125944651 | 12594465 | 9 | SS | SEROQUEL | QUETIAPINE FUMARATE | 1 | Unknown | U | U | 0 | |||||||||
| 125944651 | 12594465 | 10 | SS | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Unknown | U | U | 0 | |||||||||
| 125944651 | 12594465 | 11 | C | OPSUMIT | MACITENTAN | 1 | 0 | ||||||||||||
| 125944651 | 12594465 | 12 | C | LETAIRIS | AMBRISENTAN | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125944651 | 12594465 | 1 | Pulmonary arterial hypertension |
| 125944651 | 12594465 | 9 | Abnormal behaviour |
| 125944651 | 12594465 | 10 | Abnormal behaviour |
| 125944651 | 12594465 | 11 | Product used for unknown indication |
| 125944651 | 12594465 | 12 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125944651 | 12594465 | Condition aggravated | |
| 125944651 | 12594465 | Insomnia | |
| 125944651 | 12594465 | Oxygen saturation decreased |
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 |
|---|---|---|---|---|---|---|
| 125944651 | 12594465 | 1 | 20150824 | 0 | ||
| 125944651 | 12594465 | 4 | 20150824 | 0 |