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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124091982 | 12409198 | 2 | F | 20160517 | 20160712 | 20160526 | 20160721 | PER | US-ACTELION-A-NJ2016-136747 | ACTELION | 54.00 | YR | A | F | Y | 0.00000 | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124091982 | 12409198 | 1 | PS | VENTAVIS | ILOPROST | 1 | Respiratory (inhalation) | 5 MCG, 6-9 X DAILY | MA02B5I;MA02DL0 | 21779 | 5 | UG | INHALATION VAPOUR, SOLUTION | ||||||
| 124091982 | 12409198 | 2 | SS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | UM016A0201;UM019A0101 | 204410 | 10 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124091982 | 12409198 | 1 | Pulmonary arterial hypertension |
| 124091982 | 12409198 | 2 | Pulmonary arterial hypertension |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124091982 | 12409198 | Device malfunction | |
| 124091982 | 12409198 | Dyspnoea |
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 |
|---|---|---|---|---|---|---|
| 124091982 | 12409198 | 1 | 20160412 | 0 | ||
| 124091982 | 12409198 | 2 | 20160322 | 0 |