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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1024743513 | 10247435 | 13 | F | 20140604 | 20150818 | 20140619 | 20160630 | EXP | US-ACTELION-A-US2014-100049 | ACTELION | 59.00 | YR | A | M | Y | 87.98000 | KG | 20160630 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1024743513 | 10247435 | 1 | PS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 114 NG/KG, PER MIN | MM032M0101,MM040M0101,MM048M0101 | 22260 | INJECTION | /min | |||||||
| 1024743513 | 10247435 | 2 | SS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 115 NG/KG, PER MIN | 6621540201, MM066M0101 | 22260 | INJECTION | /min | |||||||
| 1024743513 | 10247435 | 3 | SS | TRACLEER | BOSENTAN | 1 | Oral | U | 21290 | TABLET | |||||||||
| 1024743513 | 10247435 | 4 | SS | REVATIO | SILDENAFIL CITRATE | 1 | Oral | 20 MG, TID | 0 | 20 | MG | TID | |||||||
| 1024743513 | 10247435 | 5 | C | LETAIRIS | AMBRISENTAN | 1 | UNK | U | 0 | ||||||||||
| 1024743513 | 10247435 | 6 | C | ADCIRCA | TADALAFIL | 1 | U | 0 | |||||||||||
| 1024743513 | 10247435 | 7 | C | ASPIRIN. | ASPIRIN | 1 | U | 0 | |||||||||||
| 1024743513 | 10247435 | 8 | C | COUMADIN | WARFARIN SODIUM | 1 | 7.5 MG, 6 DAYS/WK | U | 0 | 7.5 | MG | ||||||||
| 1024743513 | 10247435 | 9 | C | COUMADIN | WARFARIN SODIUM | 1 | 10 MG, 1 DAY/WK | U | 0 | 10 | MG | ||||||||
| 1024743513 | 10247435 | 10 | C | CHLORHEXIDINE | CHLORHEXIDINE | 1 | U | 0 | |||||||||||
| 1024743513 | 10247435 | 11 | C | IODINE. | IODINE | 1 | U | 0 | |||||||||||
| 1024743513 | 10247435 | 12 | C | OXYGEN. | OXYGEN | 1 | U | 0 | |||||||||||
| 1024743513 | 10247435 | 13 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | UNK | U | 0 | ||||||||||
| 1024743513 | 10247435 | 14 | C | IRON | IRON | 1 | UNK | U | 0 | ||||||||||
| 1024743513 | 10247435 | 15 | C | MULTIVITAMIN | VITAMINS | 1 | UNK | U | 0 | ||||||||||
| 1024743513 | 10247435 | 16 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1024743513 | 10247435 | 1 | Pulmonary arterial hypertension |
| 1024743513 | 10247435 | 3 | Pulmonary arterial hypertension |
| 1024743513 | 10247435 | 4 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1024743513 | 10247435 | HO |
| 1024743513 | 10247435 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1024743513 | 10247435 | Anticoagulation drug level increased | |
| 1024743513 | 10247435 | Arthralgia | |
| 1024743513 | 10247435 | Catheter placement | |
| 1024743513 | 10247435 | Catheter site discharge | |
| 1024743513 | 10247435 | Catheter site erythema | |
| 1024743513 | 10247435 | Catheter site infection | |
| 1024743513 | 10247435 | Central venous catheterisation | |
| 1024743513 | 10247435 | Decreased appetite | |
| 1024743513 | 10247435 | Device alarm issue | |
| 1024743513 | 10247435 | Device occlusion | |
| 1024743513 | 10247435 | Device related thrombosis | |
| 1024743513 | 10247435 | Dyspnoea | |
| 1024743513 | 10247435 | Haemorrhage | |
| 1024743513 | 10247435 | Hip fracture | |
| 1024743513 | 10247435 | Malaise | |
| 1024743513 | 10247435 | Skin irritation | |
| 1024743513 | 10247435 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 1024743513 | 10247435 | 1 | 20100127 | 0 | ||
| 1024743513 | 10247435 | 4 | 201001 | 0 | ||
| 1024743513 | 10247435 | 5 | 201101 | 0 | ||
| 1024743513 | 10247435 | 8 | 2015 | 0 | ||
| 1024743513 | 10247435 | 13 | 201101 | 0 | ||
| 1024743513 | 10247435 | 14 | 201101 | 0 | ||
| 1024743513 | 10247435 | 15 | 201001 | 0 |