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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123950613 | 12395061 | 3 | F | 20160705 | 20160810 | 20160523 | 20160819 | EXP | US-ACTELION-A-US2016-134328 | ACTELION | 7.00 | MON | I | M | Y | 0.00000 | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123950613 | 12395061 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 15.625 MG, QD | NP013P0402 | 21290 | 15.625 | MG | TABLET | QD | |||||
| 123950613 | 12395061 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 12.5 MG, QD | 21290 | 12.5 | MG | TABLET | QD | ||||||
| 123950613 | 12395061 | 3 | SS | VENTAVIS | ILOPROST | 1 | Respiratory (inhalation) | 1-2 MCG, TID | Y | MA02A59 | 21779 | INHALATION VAPOUR, SOLUTION | TID | ||||||
| 123950613 | 12395061 | 4 | C | SILDENAFIL. | SILDENAFIL | 1 | 4 MG, TID | U | 0 | 4 | MG | TID | |||||||
| 123950613 | 12395061 | 5 | C | REMODULIN | TREPROSTINIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123950613 | 12395061 | 1 | Pulmonary arterial hypertension |
| 123950613 | 12395061 | 3 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123950613 | 12395061 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123950613 | 12395061 | Atrial septal defect repair | |
| 123950613 | 12395061 | Catheter site erythema | |
| 123950613 | 12395061 | Catheter site infection | |
| 123950613 | 12395061 | Catheter site swelling | |
| 123950613 | 12395061 | Condition aggravated | |
| 123950613 | 12395061 | Device breakage | |
| 123950613 | 12395061 | Mechanical ventilation | |
| 123950613 | 12395061 | Nasopharyngitis | |
| 123950613 | 12395061 | Patent ductus arteriosus repair | |
| 123950613 | 12395061 | Pleurodesis | |
| 123950613 | 12395061 | Pneumothorax | |
| 123950613 | 12395061 | Respiratory distress | |
| 123950613 | 12395061 | Urinary tract infection | |
| 123950613 | 12395061 | Venous repair |
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 |
|---|---|---|---|---|---|---|
| 123950613 | 12395061 | 1 | 20151223 | 0 | ||
| 123950613 | 12395061 | 3 | 201603 | 0 | ||
| 123950613 | 12395061 | 4 | 201601 | 0 |