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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123830764 | 12383076 | 4 | F | 20160419 | 20160621 | 20160518 | 20160705 | EXP | US-ACTELION-A-US2016-135544 | ACTELION | 25.00 | YR | A | F | Y | 0.00000 | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123830764 | 12383076 | 1 | PS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 8 NG/KG, PER MIN | Y | MM083M0101 | 22260 | INJECTION | /min | ||||||
| 123830764 | 12383076 | 2 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | 10 MG, QD | U | U | 0 | 10 | MG | QD | |||||
| 123830764 | 12383076 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | U | U | 0 | |||||||||
| 123830764 | 12383076 | 4 | C | REVATIO | SILDENAFIL CITRATE | 1 | 40 MG, TID | U | 0 | 40 | MG | TID | |||||||
| 123830764 | 12383076 | 5 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123830764 | 12383076 | 1 | Pulmonary arterial hypertension |
| 123830764 | 12383076 | 2 | Product used for unknown indication |
| 123830764 | 12383076 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123830764 | 12383076 | HO |
| 123830764 | 12383076 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123830764 | 12383076 | Device deployment issue | |
| 123830764 | 12383076 | Drug administration error | |
| 123830764 | 12383076 | Hypotension | |
| 123830764 | 12383076 | Presyncope |
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 |
|---|---|---|---|---|---|---|
| 123830764 | 12383076 | 1 | 20160330 | 201604 | 0 | |
| 123830764 | 12383076 | 2 | 20090415 | 0 |