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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107338504 | 10733850 | 4 | F | 20141104 | 20160322 | 20150123 | 20160331 | EXP | US-ACTELION-A-US2015-111407 | ACTELION | 81.00 | YR | E | F | Y | 0.00000 | 20160331 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107338504 | 10733850 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | 82250 | MG | 21290 | 125 | MG | TABLET | BID | ||||
| 107338504 | 10733850 | 2 | SS | CADUET | AMLODIPINE BESYLATEATORVASTATIN CALCIUM | 1 | Unknown | U | 0 | ||||||||||
| 107338504 | 10733850 | 3 | SS | REVATIO | SILDENAFIL CITRATE | 1 | Oral | 20 MG, TID | U | 0 | 20 | MG | TID | ||||||
| 107338504 | 10733850 | 4 | C | COUMADIN | WARFARIN SODIUM | 1 | 2 MG, UNK | U | 0 | 2 | MG | ||||||||
| 107338504 | 10733850 | 5 | C | COUMADIN | WARFARIN SODIUM | 1 | 3 MG, UNK | U | 0 | 3 | MG | ||||||||
| 107338504 | 10733850 | 6 | C | ASPIRIN. | ASPIRIN | 1 | 81 MG, QD | U | 0 | 81 | MG | QD | |||||||
| 107338504 | 10733850 | 7 | C | LASIX | FUROSEMIDE | 1 | 20 MG, QOD (M,W.F) | U | 0 | 20 | MG | QOD | |||||||
| 107338504 | 10733850 | 8 | C | DIGOXIN. | DIGOXIN | 1 | 0.125 MG, BID | U | 0 | .125 | MG | BID | |||||||
| 107338504 | 10733850 | 9 | C | METOPROLOL. | METOPROLOL | 1 | 12.5 MG, UNK | U | 0 | 12.5 | MG | ||||||||
| 107338504 | 10733850 | 10 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | 25 MG, UNK | U | 0 | 25 | MG | QD | |||||||
| 107338504 | 10733850 | 11 | C | POTASSIUM | POTASSIUM | 1 | 8 MEQ, QD | U | 0 | 8 | MEQ | QD | |||||||
| 107338504 | 10733850 | 12 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 107338504 | 10733850 | 13 | C | VITAMIN C | ASCORBIC ACID | 1 | U | 0 | |||||||||||
| 107338504 | 10733850 | 14 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 107338504 | 10733850 | 15 | C | FISH OIL | FISH OIL | 1 | U | 0 | |||||||||||
| 107338504 | 10733850 | 16 | C | COQ10 | UBIDECARENONE | 1 | U | 0 | |||||||||||
| 107338504 | 10733850 | 17 | C | SLOW MAG | MAGNESIUM CHLORIDE | 1 | 64 MG, QD | U | 0 | 64 | MG | QD | |||||||
| 107338504 | 10733850 | 18 | C | O2 | 2 | 3 L, CONTINOUSLY | U | 0 | 3 | L | |||||||||
| 107338504 | 10733850 | 19 | C | HYDROCODONE | HYDROCODONE | 1 | UNK, PRN | U | 0 | ||||||||||
| 107338504 | 10733850 | 20 | C | MULTIVITAMIN | VITAMINS | 1 | U | 0 | |||||||||||
| 107338504 | 10733850 | 21 | C | XARELTO | RIVAROXABAN | 1 | 20 MG, UNK | U | 0 | 20 | MG | ||||||||
| 107338504 | 10733850 | 22 | C | LETAIRIS | AMBRISENTAN | 1 | 5 MG, QD | U | 0 | 5 | MG | QD | |||||||
| 107338504 | 10733850 | 23 | C | AZELASTINE | AZELASTINE | 1 | Respiratory (inhalation) | 205.5 UNK, UNK | U | 0 | 205.5 | UG | |||||||
| 107338504 | 10733850 | 24 | C | CARVEDILOL. | CARVEDILOL | 1 | 3.125 MG, BID | U | 0 | 3.125 | MG | BID | |||||||
| 107338504 | 10733850 | 25 | C | FLUTICASONE | FLUTICASONEFLUTICASONE PROPIONATE | 1 | 50 MCG, PRN | U | 0 | 50 | UG | ||||||||
| 107338504 | 10733850 | 26 | C | KLOR-CON | POTASSIUM CHLORIDE | 1 | 8 MEQ, QD | U | 0 | 8 | MEQ | QD | |||||||
| 107338504 | 10733850 | 27 | C | FUROSEMIDE. | FUROSEMIDE | 1 | 40 MG, QD | U | 0 | 40 | MG | QD | |||||||
| 107338504 | 10733850 | 28 | C | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | 10 MG-325 MG, BID | U | 0 | BID | |||||||||
| 107338504 | 10733850 | 29 | C | WARFARIN | WARFARIN | 1 | 2-3 MG, UNK | U | 0 | 2 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 107338504 | 10733850 | 1 | Pulmonary arterial hypertension |
| 107338504 | 10733850 | 2 | Product used for unknown indication |
| 107338504 | 10733850 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 107338504 | 10733850 | HO |
| 107338504 | 10733850 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 107338504 | 10733850 | Aspartate aminotransferase increased | |
| 107338504 | 10733850 | Cardiac disorder | |
| 107338504 | 10733850 | Catheterisation cardiac | |
| 107338504 | 10733850 | Drug ineffective | |
| 107338504 | 10733850 | Skin discolouration | |
| 107338504 | 10733850 | Vascular stent restenosis |
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 |
|---|---|---|---|---|---|---|
| 107338504 | 10733850 | 1 | 20131210 | 20160208 | 0 | |
| 107338504 | 10733850 | 22 | 20160222 | 0 |