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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125308285 | 12530828 | 5 | F | 201605 | 20160816 | 20160706 | 20160823 | EXP | US-UNITED THERAPEUTICS-UNT-2016-008634 | UNITED THERAPEUTICS | 59.87 | YR | F | Y | 69.84000 | KG | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125308285 | 12530828 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.375 MG, TID | Y | 2100476 | 203496 | .375 | MG | TABLET | TID | ||||
| 125308285 | 12530828 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | Y | 2100676 | 203496 | TABLET | |||||||
| 125308285 | 12530828 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.75 MG, TID | Y | 2100476 | 203496 | .75 | MG | TABLET | TID | ||||
| 125308285 | 12530828 | 4 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.5 MG, TID | Y | 2100476 | 203496 | .5 | MG | TABLET | TID | ||||
| 125308285 | 12530828 | 5 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | 10 MG, QD | 1503901A | 0 | 10 | MG | TABLET | QD | |||||
| 125308285 | 12530828 | 6 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | UNK | 1504768A | 0 | TABLET | ||||||||
| 125308285 | 12530828 | 7 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | UNK | 1509427A | 0 | TABLET | ||||||||
| 125308285 | 12530828 | 8 | SS | LETAIRIS | AMBRISENTAN | 1 | UNK | 1509507A | 0 | TABLET | |||||||||
| 125308285 | 12530828 | 9 | C | ADCIRCA | TADALAFIL | 1 | 0 | ||||||||||||
| 125308285 | 12530828 | 10 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | 0 | ||||||||||||
| 125308285 | 12530828 | 11 | C | TYLENOL | ACETAMINOPHEN | 1 | 0 | ||||||||||||
| 125308285 | 12530828 | 12 | C | REVATIO | SILDENAFIL CITRATE | 1 | 0 | ||||||||||||
| 125308285 | 12530828 | 13 | C | UPTRAVI | SELEXIPAG | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125308285 | 12530828 | 1 | Pulmonary arterial hypertension |
| 125308285 | 12530828 | 5 | Pulmonary arterial hypertension |
| 125308285 | 12530828 | 9 | Product used for unknown indication |
| 125308285 | 12530828 | 10 | Product used for unknown indication |
| 125308285 | 12530828 | 11 | Product used for unknown indication |
| 125308285 | 12530828 | 12 | Product used for unknown indication |
| 125308285 | 12530828 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125308285 | 12530828 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125308285 | 12530828 | Headache | |
| 125308285 | 12530828 | Migraine | |
| 125308285 | 12530828 | Nausea | |
| 125308285 | 12530828 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 125308285 | 12530828 | 1 | 20160513 | 20160705 | 0 | |
| 125308285 | 12530828 | 5 | 20121026 | 0 |