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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124763662 | 12476366 | 2 | F | 20160602 | 20160624 | 20160617 | 20160706 | EXP | US-ACTELION-A-US2015-129129 | ACTELION | 55.00 | YR | A | M | Y | 0.00000 | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124763662 | 12476366 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | N | 21290 | 125 | MG | TABLET | BID | |||||
| 124763662 | 12476366 | 2 | C | HEPARIN SODIUM PORCINE | HEPARIN SODIUM | 1 | Subcutaneous | 5000 U, Q8H | U | 0 | |||||||||
| 124763662 | 12476366 | 3 | C | NOVOLOG | INSULIN ASPART | 1 | Subcutaneous | 2-8 UNITS, TID | U | 0 | TID | ||||||||
| 124763662 | 12476366 | 4 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | 4 MG, UNK | U | 0 | 4 | MG | ||||||||
| 124763662 | 12476366 | 5 | C | BUMEX | BUMETANIDE | 1 | Oral | 1 MG, QD | U | 0 | 1 | MG | QD | ||||||
| 124763662 | 12476366 | 6 | C | LEVAQUIN | LEVOFLOXACIN | 1 | Oral | 750 MG, UNK | U | 0 | 750 | MG | QD | ||||||
| 124763662 | 12476366 | 7 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | 1 PACKET, QD/PRN | U | 0 | QD | |||||||||
| 124763662 | 12476366 | 8 | C | SENOKOT | SENNOSIDES | 1 | Oral | 8.6 MG, BID, PRN | U | 0 | 8.6 | MG | BID | ||||||
| 124763662 | 12476366 | 9 | C | PERI-COLACE | CASANTHRANOLDOCUSATE SODIUM | 1 | Oral | 50 MG, QD, PRN | U | 0 | 50 | MG | QD | ||||||
| 124763662 | 12476366 | 10 | C | VANCOMYCIN | VANCOMYCIN | 1 | Intravenous (not otherwise specified) | 1.75 G, Q12HRS | U | 0 | 1.75 | G | BID | ||||||
| 124763662 | 12476366 | 11 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 650 MG, UNK | U | 0 | 650 | MG | |||||||
| 124763662 | 12476366 | 12 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 10 MG, UNK | U | 0 | 10 | MG | QD | ||||||
| 124763662 | 12476366 | 13 | C | COMBIVENT RESPIMAT | ALBUTEROL SULFATEIPRATROPIUM BROMIDE | 1 | Respiratory (inhalation) | 20-100 MCG/2PUFFS, QID | U | 0 | QID | ||||||||
| 124763662 | 12476366 | 14 | C | LANOXIN | DIGOXIN | 1 | Oral | 0.125 MG, UNK | U | 0 | .125 | MG | QD | ||||||
| 124763662 | 12476366 | 15 | C | REVATIO | SILDENAFIL CITRATE | 1 | Oral | 20 MG, UNK | U | 0 | 20 | MG | QD | ||||||
| 124763662 | 12476366 | 16 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | Oral | 20 MG, UNK | U | 0 | 20 | MG | QD | ||||||
| 124763662 | 12476366 | 17 | C | ZOCOR | SIMVASTATIN | 1 | Oral | 40 MG, UNK | U | 0 | 40 | MG | QD | ||||||
| 124763662 | 12476366 | 18 | C | PROVENTIL | ALBUTEROL | 1 | Respiratory (inhalation) | 2.5 MG/3ML, QID, PRN | U | 0 | 2.5 | MG | QID | ||||||
| 124763662 | 12476366 | 19 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | Respiratory (inhalation) | 2 SPRAYS, Q2H, PRN | U | 0 | |||||||||
| 124763662 | 12476366 | 20 | C | XANAX | ALPRAZOLAM | 1 | Oral | .25 MG, PRN | U | 0 | |||||||||
| 124763662 | 12476366 | 21 | C | OXYGEN. | OXYGEN | 1 | 5 L/MIN AT REST/10 L/MIN WITH ACTIVITY CONTINUES | U | 0 | ||||||||||
| 124763662 | 12476366 | 22 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | 2000 U, QD | U | 0 | QD | ||||||||
| 124763662 | 12476366 | 23 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 81 MG, UNK | U | 0 | 81 | MG | QD | ||||||
| 124763662 | 12476366 | 24 | C | LASIX | FUROSEMIDE | 1 | U | 0 | |||||||||||
| 124763662 | 12476366 | 25 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 124763662 | 12476366 | 26 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124763662 | 12476366 | 1 | Pulmonary arterial hypertension |
| 124763662 | 12476366 | 26 | Essential hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124763662 | 12476366 | HO |
| 124763662 | 12476366 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124763662 | 12476366 | Concomitant disease aggravated | |
| 124763662 | 12476366 | Condition aggravated | |
| 124763662 | 12476366 | Death | |
| 124763662 | 12476366 | Disease progression | |
| 124763662 | 12476366 | Hypercapnia | |
| 124763662 | 12476366 | Pneumonia | |
| 124763662 | 12476366 | Pulmonary fibrosis | |
| 124763662 | 12476366 | Respiratory failure | |
| 124763662 | 12476366 | Sarcoidosis |
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 |
|---|---|---|---|---|---|---|
| 124763662 | 12476366 | 1 | 20140304 | 0 |