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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114008095 | 11400809 | 5 | F | 20160722 | 20150820 | 20160804 | PER | US-ACTELION PHARMACEUTICALS US, INC.-A-NJ2015-122394 | ACTELION | 28.00 | YR | A | F | Y | 0.00000 | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114008095 | 11400809 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | UM013A0501,UM014A0101,UM016A0201 | 204410 | 10 | MG | TABLET | QD | |||||
| 114008095 | 11400809 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous (not otherwise specified) | U | U | 0 | |||||||||
| 114008095 | 11400809 | 3 | C | ADCIRCA | TADALAFIL | 1 | U | 0 | |||||||||||
| 114008095 | 11400809 | 4 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 114008095 | 11400809 | 5 | C | TREPROSTINIL DIOLAMIN | TREPROSTINIL DIOLAMINE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114008095 | 11400809 | 1 | Pulmonary hypertension |
| 114008095 | 11400809 | 2 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114008095 | 11400809 | Abdominal pain upper | |
| 114008095 | 11400809 | Catheter site infection | |
| 114008095 | 11400809 | Catheter site pain | |
| 114008095 | 11400809 | Cellulitis | |
| 114008095 | 11400809 | Headache | |
| 114008095 | 11400809 | Pain | |
| 114008095 | 11400809 | Pruritus | |
| 114008095 | 11400809 | Rash papular | |
| 114008095 | 11400809 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 114008095 | 11400809 | 1 | 20150601 | 0 |