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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125952301 | 12595230 | 1 | I | 201601 | 20160116 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2016-000793 | UNITED THERAPEUTICS | 69.13 | YR | F | Y | 108.39000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125952301 | 12595230 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 2.5 MG, BID, WITH FOOD | N | 2100679 | 203496 | 2.5 | MG | TABLET | BID | ||||
| 125952301 | 12595230 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 2.5 MG, QD | N | 2100679 | 203496 | 2.5 | MG | TABLET | QD | ||||
| 125952301 | 12595230 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 2.5 MG, Q12H WITH FOOD | N | 2100679 | 203496 | 2.5 | MG | TABLET | BID | ||||
| 125952301 | 12595230 | 4 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | 10 MG, QD | 1500225A | 0 | 10 | MG | TABLET | QD | |||||
| 125952301 | 12595230 | 5 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | UNK | 1500227A | 0 | TABLET | ||||||||
| 125952301 | 12595230 | 6 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | UNK | 1504767A | 0 | TABLET | ||||||||
| 125952301 | 12595230 | 7 | C | ADEMPAS | RIOCIGUAT | 1 | Unknown | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125952301 | 12595230 | 1 | Pulmonary arterial hypertension |
| 125952301 | 12595230 | 4 | Product used for unknown indication |
| 125952301 | 12595230 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125952301 | 12595230 | Arthralgia | |
| 125952301 | 12595230 | Dizziness | |
| 125952301 | 12595230 | Headache | |
| 125952301 | 12595230 | Oedema peripheral | |
| 125952301 | 12595230 | Off label use | |
| 125952301 | 12595230 | Pain | |
| 125952301 | 12595230 | Pain in extremity | |
| 125952301 | 12595230 | Product use issue | |
| 125952301 | 12595230 | Rheumatoid arthritis |
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 |
|---|---|---|---|---|---|---|
| 125952301 | 12595230 | 1 | 20150831 | 0 | ||
| 125952301 | 12595230 | 2 | 20160211 | 0 | ||
| 125952301 | 12595230 | 4 | 20130314 | 0 |