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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121470499 | 12147049 | 9 | F | 201512 | 20160920 | 20160304 | 20160930 | EXP | US-ACTELION-A-NJ2016-130659 | ACTELION | 39.00 | YR | A | F | Y | 0.00000 | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121470499 | 12147049 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP019P0101,OP021P0101,IP013P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 121470499 | 12147049 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP023P0101, OP026P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 121470499 | 12147049 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | U | 0 | ||||||||||
| 121470499 | 12147049 | 4 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous (not otherwise specified) | UNK | U | 0 | |||||||||
| 121470499 | 12147049 | 5 | C | REVATIO | SILDENAFIL CITRATE | 1 | Y | U | 0 | ||||||||||
| 121470499 | 12147049 | 6 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 121470499 | 12147049 | 7 | C | ADEMPAS | RIOCIGUAT | 1 | 1.5 MG, UNK | Y | 0 | 1.5 | MG | ||||||||
| 121470499 | 12147049 | 8 | C | ADEMPAS | RIOCIGUAT | 1 | 1 MG, UNK | Y | 0 | 1 | MG | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121470499 | 12147049 | 1 | Pulmonary arterial hypertension |
| 121470499 | 12147049 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121470499 | 12147049 | HO |
| 121470499 | 12147049 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121470499 | 12147049 | Arthralgia | |
| 121470499 | 12147049 | Ascites | |
| 121470499 | 12147049 | Asthenia | |
| 121470499 | 12147049 | Bronchitis | |
| 121470499 | 12147049 | Catheter site infection | |
| 121470499 | 12147049 | Catheter site rash | |
| 121470499 | 12147049 | Chest pain | |
| 121470499 | 12147049 | Constipation | |
| 121470499 | 12147049 | Contusion | |
| 121470499 | 12147049 | Dermatitis contact | |
| 121470499 | 12147049 | Diarrhoea | |
| 121470499 | 12147049 | Dizziness | |
| 121470499 | 12147049 | Dyspnoea | |
| 121470499 | 12147049 | Fall | |
| 121470499 | 12147049 | Fatigue | |
| 121470499 | 12147049 | Feeling abnormal | |
| 121470499 | 12147049 | Feeling hot | |
| 121470499 | 12147049 | Flushing | |
| 121470499 | 12147049 | Headache | |
| 121470499 | 12147049 | Joint swelling | |
| 121470499 | 12147049 | Nausea | |
| 121470499 | 12147049 | Oedema peripheral | |
| 121470499 | 12147049 | Pain | |
| 121470499 | 12147049 | Pain in jaw | |
| 121470499 | 12147049 | Palpitations | |
| 121470499 | 12147049 | Pneumonia | |
| 121470499 | 12147049 | Seizure | |
| 121470499 | 12147049 | Suprapubic pain | |
| 121470499 | 12147049 | Syncope | |
| 121470499 | 12147049 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 121470499 | 12147049 | 1 | 20120410 | 0 | ||
| 121470499 | 12147049 | 7 | 20160725 | 0 | ||
| 121470499 | 12147049 | 8 | 20160725 | 0 |