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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116560537 | 11656053 | 7 | F | 20160802 | 20151023 | 20160805 | EXP | US-ACTELION PHARMACEUTICALS US, INC.-A-US2015-113731 | ACTELION | 51.00 | YR | A | F | Y | 0.00000 | 20160805 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116560537 | 11656053 | 1 | PS | VENTAVIS | ILOPROST | 1 | Respiratory (inhalation) | 2.5 MCG, 6-9X DAILY | Y | MA00ZHE/MA025AV | 21779 | 2.5 | UG | INHALATION VAPOUR, SOLUTION | |||||
| 116560537 | 11656053 | 2 | SS | VENTAVIS | ILOPROST | 1 | Respiratory (inhalation) | 2.5 MCG, 4 X/DAILY | Y | MA025AV, MA02A59 | 21779 | 2.5 | UG | INHALATION VAPOUR, SOLUTION | |||||
| 116560537 | 11656053 | 3 | SS | VENTAVIS | ILOPROST | 1 | Respiratory (inhalation) | 5 MCG, 6-9X DAILY | Y | MA025AV | 21779 | 5 | UG | INHALATION VAPOUR, SOLUTION | |||||
| 116560537 | 11656053 | 4 | SS | VENTAVIS | ILOPROST | 1 | Respiratory (inhalation) | 2.5 MCG, 6X DAILY | Y | MA02A59 | 21779 | 2.5 | UG | INHALATION VAPOUR, SOLUTION | |||||
| 116560537 | 11656053 | 5 | C | ADCIRCA | TADALAFIL | 1 | U | 0 | |||||||||||
| 116560537 | 11656053 | 6 | C | LETAIRIS | AMBRISENTAN | 1 | U | 0 | |||||||||||
| 116560537 | 11656053 | 7 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 116560537 | 11656053 | 8 | C | DILTIAZEM. | DILTIAZEM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116560537 | 11656053 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116560537 | 11656053 | LT |
| 116560537 | 11656053 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116560537 | 11656053 | Chest pain | |
| 116560537 | 11656053 | Condition aggravated | |
| 116560537 | 11656053 | Dizziness | |
| 116560537 | 11656053 | Drug administration error | |
| 116560537 | 11656053 | Dyspnoea | |
| 116560537 | 11656053 | Dyspnoea exertional | |
| 116560537 | 11656053 | Flushing | |
| 116560537 | 11656053 | Headache | |
| 116560537 | 11656053 | Malaise | |
| 116560537 | 11656053 | Oxygen saturation decreased | |
| 116560537 | 11656053 | Pulmonary arterial hypertension | |
| 116560537 | 11656053 | Pulmonary hypertension | |
| 116560537 | 11656053 | Pulmonary pain | |
| 116560537 | 11656053 | Vomiting | |
| 116560537 | 11656053 | 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 |
|---|---|---|---|---|---|---|
| 116560537 | 11656053 | 1 | 20140807 | 0 |