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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114138877 | 11413887 | 7 | F | 20160831 | 20150824 | 20160906 | EXP | US-ACTELION-A-US2015-122723 | ACTELION | 78.00 | YR | E | F | Y | 0.00000 | 20160907 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114138877 | 11413887 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | UM014A0101,UM016A0201, UM019A0101 | 204410 | 10 | MG | TABLET | QD | |||||
| 114138877 | 11413887 | 2 | SS | VENTAVIS | ILOPROST | 1 | Respiratory (inhalation) | 5 MCG, 6-9 X/DAY | Y | MA025AV,MA026TA,MA0299Z,MA0299Z | 21779 | 5 | UG | INHALATION VAPOUR, SOLUTION | |||||
| 114138877 | 11413887 | 3 | C | ADCIRCA | TADALAFIL | 1 | U | 0 | |||||||||||
| 114138877 | 11413887 | 4 | C | OXYGEN. | OXYGEN | 1 | 6 L/MIN, UNK | U | 0 | ||||||||||
| 114138877 | 11413887 | 5 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114138877 | 11413887 | 1 | Pulmonary arterial hypertension |
| 114138877 | 11413887 | 2 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114138877 | 11413887 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114138877 | 11413887 | Cough | |
| 114138877 | 11413887 | Dyspnoea | |
| 114138877 | 11413887 | Hot flush | |
| 114138877 | 11413887 | Malaise | |
| 114138877 | 11413887 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 114138877 | 11413887 | 1 | 20150130 | 0 | ||
| 114138877 | 11413887 | 2 | 20150817 | 201605 | 0 |