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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116527996 | 11652799 | 6 | F | 20150613 | 20160801 | 20151022 | 20160812 | EXP | US-ACTELION-A-NJ2015-114677 | ACTELION | 87.00 | YR | E | F | Y | 0.00000 | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116527996 | 11652799 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | EP105P0101,IP060P0101,OP019P0101 | 21290 | 62.5 | MG | TABLET | BID | |||||
| 116527996 | 11652799 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP021P0101;IP053P0101, IP055P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 116527996 | 11652799 | 3 | C | RIOCIGUAT | RIOCIGUAT | 1 | 2.5 MG, TID | Y | U | 0 | 2.5 | MG | TID | ||||||
| 116527996 | 11652799 | 4 | C | TYVASO | TREPROSTINIL | 1 | UNK | Y | U | 0 | |||||||||
| 116527996 | 11652799 | 5 | C | COUMADIN | WARFARIN SODIUM | 1 | 7.5 MG, UNK | U | 0 | 7.5 | MG | QD | |||||||
| 116527996 | 11652799 | 6 | C | ASPIRIN. | ASPIRIN | 1 | U | 0 | |||||||||||
| 116527996 | 11652799 | 7 | C | DUONEB | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | UNK, Q6HRS | U | 0 | QID | |||||||||
| 116527996 | 11652799 | 8 | C | PROAIR HFA | ALBUTEROL SULFATE | 1 | UNK | U | 0 | ||||||||||
| 116527996 | 11652799 | 9 | C | BROVANA | ARFORMOTEROL TARTRATE | 1 | UNK UNK, BID | U | 0 | BID | |||||||||
| 116527996 | 11652799 | 10 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 1000 U, UNK | U | 0 | QD | |||||||||
| 116527996 | 11652799 | 11 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | 60 MG, QD | U | 0 | 60 | MG | QD | |||||||
| 116527996 | 11652799 | 12 | C | ALLEGRA | FEXOFENADINE HYDROCHLORIDE | 1 | 180 MG, UNK | U | 0 | 180 | MG | QD | |||||||
| 116527996 | 11652799 | 13 | C | LASIX | FUROSEMIDE | 1 | 40 MG, UNK | U | 0 | 40 | MG | QD | |||||||
| 116527996 | 11652799 | 14 | C | INSULIN | INSULIN NOS | 1 | 65 U, QAM | U | 0 | QD | |||||||||
| 116527996 | 11652799 | 15 | C | INSULIN | INSULIN NOS | 1 | 35 U, QPM | U | 0 | QD | |||||||||
| 116527996 | 11652799 | 16 | C | METOPROLOL. | METOPROLOL | 1 | 50 MG, BID | U | 0 | 50 | MG | BID | |||||||
| 116527996 | 11652799 | 17 | C | METOPROLOL. | METOPROLOL | 1 | 100 MG, QPM | U | 0 | 100 | MG | QD | |||||||
| 116527996 | 11652799 | 18 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | 10 MG, UNK | U | 0 | 10 | MG | QD | |||||||
| 116527996 | 11652799 | 19 | C | FLONASE | FLUTICASONE PROPIONATE | 1 | UNK | U | 0 | ||||||||||
| 116527996 | 11652799 | 20 | C | KCL | POTASSIUM CHLORIDE | 1 | 20 MEQ, UNK | U | 0 | 20 | MEQ | QD | |||||||
| 116527996 | 11652799 | 21 | C | VITAMINS | VITAMINS | 1 | UNK | U | 0 | ||||||||||
| 116527996 | 11652799 | 22 | C | OCUVITE | VITAMINS | 1 | UNK | U | 0 | ||||||||||
| 116527996 | 11652799 | 23 | C | XANAX | ALPRAZOLAM | 1 | 0.25 MG, BID | U | 0 | .25 | MG | BID | |||||||
| 116527996 | 11652799 | 24 | C | PULMICORT TURBUHALER | BUDESONIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116527996 | 11652799 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116527996 | 11652799 | LT |
| 116527996 | 11652799 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116527996 | 11652799 | Abdominal pain | |
| 116527996 | 11652799 | Atrial fibrillation | |
| 116527996 | 11652799 | Atrial flutter | |
| 116527996 | 11652799 | Cardiac failure congestive | |
| 116527996 | 11652799 | Diarrhoea | |
| 116527996 | 11652799 | Dysentery | |
| 116527996 | 11652799 | Dyspnoea | |
| 116527996 | 11652799 | Dyspnoea exertional | |
| 116527996 | 11652799 | Fall | |
| 116527996 | 11652799 | Fatigue | |
| 116527996 | 11652799 | Gastrointestinal haemorrhage | |
| 116527996 | 11652799 | Haemoptysis | |
| 116527996 | 11652799 | Hyperglycaemia | |
| 116527996 | 11652799 | Musculoskeletal chest pain | |
| 116527996 | 11652799 | Oedema peripheral | |
| 116527996 | 11652799 | Oxygen saturation decreased | |
| 116527996 | 11652799 | Pneumonia | |
| 116527996 | 11652799 | Pulmonary hypertension | |
| 116527996 | 11652799 | Pulmonary oedema | |
| 116527996 | 11652799 | Respiratory failure | |
| 116527996 | 11652799 | Vomiting | |
| 116527996 | 11652799 | White blood cell count 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 |
|---|---|---|---|---|---|---|
| 116527996 | 11652799 | 1 | 201106 | 0 | ||
| 116527996 | 11652799 | 2 | 201107 | 0 | ||
| 116527996 | 11652799 | 4 | 2015 | 0 |