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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118596686 | 11859668 | 6 | F | 201607 | 20160727 | 20151221 | 20160810 | EXP | US-ACTELION-A-US2015-128805 | ACTELION | 39.00 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118596686 | 11859668 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | UM017N0301, UM016A0201, UM019A0101 | 204410 | 10 | MG | TABLET | QD | |||||
| 118596686 | 11859668 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | U | 0 | |||||||||
| 118596686 | 11859668 | 3 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 118596686 | 11859668 | 4 | C | RIOCIGUAT | RIOCIGUAT | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118596686 | 11859668 | 1 | Pulmonary arterial hypertension |
| 118596686 | 11859668 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118596686 | 11859668 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118596686 | 11859668 | Agitation | |
| 118596686 | 11859668 | Blood potassium decreased | |
| 118596686 | 11859668 | Cardiac failure | |
| 118596686 | 11859668 | Dizziness | |
| 118596686 | 11859668 | Fluid retention | |
| 118596686 | 11859668 | Malaise | |
| 118596686 | 11859668 | Pain | |
| 118596686 | 11859668 | Peripheral swelling | |
| 118596686 | 11859668 | Pneumonia | |
| 118596686 | 11859668 | Syncope | |
| 118596686 | 11859668 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 118596686 | 11859668 | 1 | 20140731 | 0 |