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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124357713 | 12435771 | 3 | F | 201605 | 20160713 | 20160603 | 20160714 | PER | US-ACTELION-A-US2016-136760 | ACTELION | 72.00 | YR | E | F | Y | 0.00000 | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124357713 | 12435771 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, UNK | UM016A0201 | 204410 | 10 | MG | TABLET | ||||||
| 124357713 | 12435771 | 2 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | U | U | 0 | |||||||||
| 124357713 | 12435771 | 3 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124357713 | 12435771 | 1 | Pulmonary arterial hypertension |
| 124357713 | 12435771 | 2 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124357713 | 12435771 | Bronchitis | |
| 124357713 | 12435771 | Dyspnoea | |
| 124357713 | 12435771 | Fatigue | |
| 124357713 | 12435771 | Heart rate irregular | |
| 124357713 | 12435771 | Neck pain | |
| 124357713 | 12435771 | Respiratory tract inflammation | |
| 124357713 | 12435771 | Therapy non-responder | |
| 124357713 | 12435771 | Urinary retention | |
| 124357713 | 12435771 | Urinary tract disorder | |
| 124357713 | 12435771 | Waist circumference increased | |
| 124357713 | 12435771 | 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 |
|---|---|---|---|---|---|---|
| 124357713 | 12435771 | 1 | 20160513 | 0 |