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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121283795 | 12128379 | 5 | F | 20160209 | 20160811 | 20160229 | 20160818 | EXP | US-ACTELION-A-NJ2016-132172 | ACTELION | 80.00 | YR | E | F | Y | 0.00000 | 20160818 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121283795 | 12128379 | 1 | PS | VENTAVIS | ILOPROST | 1 | Respiratory (inhalation) | 5 MCG, 6X DAILY | MA0299X,MA02BP4 | 21779 | 5 | UG | INHALATION VAPOUR, SOLUTION | ||||||
| 121283795 | 12128379 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | 0 | 125 | MG | BID | |||||||
| 121283795 | 12128379 | 3 | SS | DIGOXIN. | DIGOXIN | 1 | Unknown | UNK | Y | U | 0 | ||||||||
| 121283795 | 12128379 | 4 | C | SILDENAFIL. | SILDENAFIL | 1 | UNK | U | 0 | ||||||||||
| 121283795 | 12128379 | 5 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 121283795 | 12128379 | 6 | C | MIDODRINE | MIDODRINE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121283795 | 12128379 | 1 | Pulmonary arterial hypertension |
| 121283795 | 12128379 | 2 | Pulmonary arterial hypertension |
| 121283795 | 12128379 | 3 | Product used for unknown indication |
| 121283795 | 12128379 | 4 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121283795 | 12128379 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121283795 | 12128379 | Atrial fibrillation | |
| 121283795 | 12128379 | Bradycardia | |
| 121283795 | 12128379 | Heart rate decreased | |
| 121283795 | 12128379 | Heart rate increased | |
| 121283795 | 12128379 | Hypotension | |
| 121283795 | 12128379 | Palpitations |
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 |
|---|---|---|---|---|---|---|
| 121283795 | 12128379 | 1 | 20060912 | 0 |