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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124694412 | 12469441 | 2 | F | 20160706 | 20160615 | 20160708 | EXP | US-ACTELION-A-NJ2016-137368 | ACTELION | 28.00 | YR | A | F | Y | 0.00000 | 20160708 | MD | IN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124694412 | 12469441 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, QD | U | U | 21290 | 125 | MG | TABLET | QD | ||||
| 124694412 | 12469441 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | U | U | 21290 | 62.5 | MG | TABLET | BID | ||||
| 124694412 | 12469441 | 3 | SS | TREPROSTINIL | TREPROSTINIL | 1 | Oral | 5 MG, BID | U | U | 0 | 5 | MG | BID | |||||
| 124694412 | 12469441 | 4 | SS | TREPROSTINIL | TREPROSTINIL | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124694412 | 12469441 | 5 | SS | CAVERTA | SILDENAFIL CITRATE | 1 | Unknown | 25 MG, BID | Y | U | 0 | 25 | MG | BID | |||||
| 124694412 | 12469441 | 6 | SS | LASILACTONE | FUROSEMIDESPIRONOLACTONE | 1 | Unknown | 50 MG, QD | Y | U | 0 | 50 | MG | QD | |||||
| 124694412 | 12469441 | 7 | SS | LASILACTONE | FUROSEMIDESPIRONOLACTONE | 1 | Unknown | 50 MG, QD | Y | U | 0 | 40 | MG | QD | |||||
| 124694412 | 12469441 | 8 | C | ACITROM | ACENOCOUMAROL | 1 | 1 MG, QD | U | U | 0 | 1 | MG | QD | ||||||
| 124694412 | 12469441 | 9 | C | SILDENAFIL. | SILDENAFIL | 1 | 25 MG | U | 0 | 25 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124694412 | 12469441 | 1 | Pulmonary arterial hypertension |
| 124694412 | 12469441 | 3 | Product used for unknown indication |
| 124694412 | 12469441 | 5 | Pulmonary arterial hypertension |
| 124694412 | 12469441 | 6 | Polyuria |
| 124694412 | 12469441 | 7 | Polyuria |
| 124694412 | 12469441 | 9 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124694412 | 12469441 | LT |
| 124694412 | 12469441 | OT |
| 124694412 | 12469441 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124694412 | 12469441 | Aspartate aminotransferase increased | |
| 124694412 | 12469441 | Back pain | |
| 124694412 | 12469441 | Chest pain | |
| 124694412 | 12469441 | Headache | |
| 124694412 | 12469441 | Hypoglycaemia | |
| 124694412 | 12469441 | Hypotension | |
| 124694412 | 12469441 | Syncope | |
| 124694412 | 12469441 | Unresponsive to stimuli | |
| 124694412 | 12469441 | Ventricular tachycardia |
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 |
|---|---|---|---|---|---|---|
| 124694412 | 12469441 | 1 | 20140825 | 20160404 | 0 | |
| 124694412 | 12469441 | 2 | 20160404 | 20160404 | 0 | |
| 124694412 | 12469441 | 3 | 20121121 | 0 | ||
| 124694412 | 12469441 | 4 | 20101126 | 0 | ||
| 124694412 | 12469441 | 5 | 20160403 | 20160404 | 0 | |
| 124694412 | 12469441 | 6 | 20160403 | 20160404 | 0 | |
| 124694412 | 12469441 | 7 | 20160403 | 20160404 | 0 | |
| 124694412 | 12469441 | 8 | 20140825 | 0 |