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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1184952312 | 11849523 | 12 | F | 20160517 | 20160803 | 20151218 | 20160809 | PER | US-ACTELION-A-US2015-128842 | ACTELION | 61.00 | YR | A | F | Y | 0.00000 | 20160809 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1184952312 | 11849523 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | UM017N0401,UM016A0201,UM019A0101 | 204410 | 10 | MG | TABLET | QD | |||||
| 1184952312 | 11849523 | 2 | SS | VENTAVIS | ILOPROST | 1 | Respiratory (inhalation) | 5 MCG, 6-9 X/DAILY | MA026TA,MA029A9,MA0299X,MA02B5I | 21779 | 5 | UG | INHALATION VAPOUR, SOLUTION | ||||||
| 1184952312 | 11849523 | 3 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 1184952312 | 11849523 | 4 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 1184952312 | 11849523 | 5 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1184952312 | 11849523 | 1 | Pulmonary arterial hypertension |
| 1184952312 | 11849523 | 2 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1184952312 | 11849523 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1184952312 | 11849523 | Ascites | |
| 1184952312 | 11849523 | Cardiac failure congestive | |
| 1184952312 | 11849523 | Device failure | |
| 1184952312 | 11849523 | Drug dose omission | |
| 1184952312 | 11849523 | Dyspnoea | |
| 1184952312 | 11849523 | Fluid retention | |
| 1184952312 | 11849523 | Oedema peripheral | |
| 1184952312 | 11849523 | Right ventricular failure |
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 |
|---|---|---|---|---|---|---|
| 1184952312 | 11849523 | 1 | 20150302 | 0 | ||
| 1184952312 | 11849523 | 2 | 20150218 | 0 |