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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 87577284 | 8757728 | 4 | F | 20160624 | 20120828 | 20160706 | EXP | US-ACTELION-A-NJ2012-70421 | ACTELION | 75.00 | YR | E | F | Y | 0.00000 | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 87577284 | 8757728 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | IP016P0101, OP021P0101;OP023P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 87577284 | 8757728 | 2 | SS | RIOCIGUAT | RIOCIGUAT | 1 | Unknown | UNK MG, UNK | U | 0 | |||||||||
| 87577284 | 8757728 | 3 | SS | RIOCIGUAT | RIOCIGUAT | 1 | 0.5 MG, TID | U | 0 | .5 | MG | TID | |||||||
| 87577284 | 8757728 | 4 | C | ADCIRCA | TADALAFIL | 1 | 0 | ||||||||||||
| 87577284 | 8757728 | 5 | C | COUMADIN | WARFARIN SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 87577284 | 8757728 | 1 | Pulmonary arterial hypertension |
| 87577284 | 8757728 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 87577284 | 8757728 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 87577284 | 8757728 | International normalised ratio increased | |
| 87577284 | 8757728 | Oedema peripheral | |
| 87577284 | 8757728 | Oropharyngeal pain | |
| 87577284 | 8757728 | Pulmonary thrombosis | |
| 87577284 | 8757728 | Swelling |
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 |
|---|---|---|---|---|---|---|
| 87577284 | 8757728 | 1 | 20110322 | 0 |