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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114812955 | 11481295 | 5 | F | 20160912 | 20150909 | 20160922 | PER | US-ACTELION PHARMACEUTICALS US, INC.-A-US2015-122588 | ACTELION | 58.00 | YR | A | F | Y | 0.00000 | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114812955 | 11481295 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | IP056P0101,OP021P0101,OP023P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 114812955 | 11481295 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Unknown | U | 0 | ||||||||||
| 114812955 | 11481295 | 3 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 | |||||||||||
| 114812955 | 11481295 | 4 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114812955 | 11481295 | 1 | Pulmonary arterial hypertension |
| 114812955 | 11481295 | 2 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114812955 | 11481295 | Device alarm issue | |
| 114812955 | 11481295 | Drug dose omission | |
| 114812955 | 11481295 | Erythema | |
| 114812955 | 11481295 | Infusion site pain | |
| 114812955 | 11481295 | Infusion site swelling | |
| 114812955 | 11481295 | Infusion site vesicles | |
| 114812955 | 11481295 | Lymphadenopathy | |
| 114812955 | 11481295 | Pain of skin | |
| 114812955 | 11481295 | Pulmonary arterial hypertension |
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 |
|---|---|---|---|---|---|---|
| 114812955 | 11481295 | 1 | 20120416 | 0 |