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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121268484 | 12126848 | 4 | F | 20160902 | 20160902 | 20160229 | 20160914 | EXP | US-ACTELION-A-NJ2015-125568 | ACTELION | 57.00 | YR | A | M | Y | 0.00000 | 20160914 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121268484 | 12126848 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, UNK | IP056P0101, OP019P0101, OP021P0101 | 21290 | 125 | MG | TABLET | ||||||
| 121268484 | 12126848 | 2 | SS | TREPROSTINIL DIOLAMIN | TREPROSTINIL DIOLAMINE | 1 | Unknown | 2.75 MG, UNK | 0 | 2.75 | MG | TID | |||||||
| 121268484 | 12126848 | 3 | C | ADCIRCA | TADALAFIL | 1 | U | 0 | |||||||||||
| 121268484 | 12126848 | 4 | C | RIOCIGUAT | RIOCIGUAT | 1 | U | 0 | |||||||||||
| 121268484 | 12126848 | 5 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 121268484 | 12126848 | 6 | C | FLOLAN | EPOPROSTENOL SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121268484 | 12126848 | 1 | Pulmonary arterial hypertension |
| 121268484 | 12126848 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121268484 | 12126848 | HO |
| 121268484 | 12126848 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121268484 | 12126848 | Bradycardia | |
| 121268484 | 12126848 | Cardiac failure | |
| 121268484 | 12126848 | Death | |
| 121268484 | 12126848 | Disease progression | |
| 121268484 | 12126848 | Heart rate increased | |
| 121268484 | 12126848 | Insomnia |
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 |
|---|---|---|---|---|---|---|
| 121268484 | 12126848 | 1 | 20091112 | 20160902 | 0 |