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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125064762 | 12506476 | 2 | F | 20160520 | 20160630 | 20160628 | 20160712 | EXP | US-ACTELION-A-US2015-127207 | ACTELION | 88.00 | YR | E | F | Y | 0.00000 | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125064762 | 12506476 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | IP056P010L;IP023P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 125064762 | 12506476 | 2 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | Oral | 20 MG, UNK | U | 0 | 20 | MG | QD | ||||||
| 125064762 | 12506476 | 3 | C | THEOPHYLLINE | THEOPHYLLINE ANHYDROUS | 1 | Oral | 200 MG, Q12HRS | U | 0 | 200 | MG | BID | ||||||
| 125064762 | 12506476 | 4 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, QAM | U | 0 | 20 | MG | QD | ||||||
| 125064762 | 12506476 | 5 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 160 MCG/4.5 MCG, 2 INHALATIONS | U | 0 | 160 | UG | BID | ||||||
| 125064762 | 12506476 | 6 | C | LASIX | FUROSEMIDE | 1 | Oral | 20 MG, UNK | U | 0 | 20 | MG | QD | ||||||
| 125064762 | 12506476 | 7 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 0.175 MG, UNK | U | 0 | .175 | MG | QD | ||||||
| 125064762 | 12506476 | 8 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 1000 MG, UNK | U | 0 | 1000 | MG | QD | ||||||
| 125064762 | 12506476 | 9 | C | COUMADIN | WARFARIN SODIUM | 1 | Oral | 6 MG, UNK | U | 0 | 6 | MG | QD | ||||||
| 125064762 | 12506476 | 10 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | U | 0 | |||||||||||
| 125064762 | 12506476 | 11 | C | CARDIZEM | DILTIAZEM HYDROCHLORIDE | 1 | 30 MG, TID | U | 0 | 30 | MG | TID | |||||||
| 125064762 | 12506476 | 12 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | 18 MCG, UNK | U | 0 | 18 | UG | ||||||||
| 125064762 | 12506476 | 13 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | 5000 IU, QD | U | 0 | 5000 | IU | QD | |||||||
| 125064762 | 12506476 | 14 | C | FOLIC ACID. | FOLIC ACID | 1 | 0.4 MG, BID | U | 0 | .4 | MG | BID | |||||||
| 125064762 | 12506476 | 15 | C | RECLAST | ZOLEDRONIC ACID | 1 | 5 MG/100 ML SOLUTION FOR INJECTION YEARLY | U | 0 | 5 | MG | ||||||||
| 125064762 | 12506476 | 16 | C | CALCIUM | CALCIUM | 1 | Oral | 600 UNK, TID | U | 0 | TID | ||||||||
| 125064762 | 12506476 | 17 | C | HYDRODIURIL | HYDROCHLOROTHIAZIDE | 1 | U | 0 | |||||||||||
| 125064762 | 12506476 | 18 | C | DIOVAN | VALSARTAN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125064762 | 12506476 | 1 | Pulmonary arterial hypertension |
| 125064762 | 12506476 | 8 | Essential hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125064762 | 12506476 | DS |
| 125064762 | 12506476 | HO |
| 125064762 | 12506476 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125064762 | 12506476 | Asthma | |
| 125064762 | 12506476 | Cardiac failure congestive | |
| 125064762 | 12506476 | Dyspnoea | |
| 125064762 | 12506476 | Fatigue | |
| 125064762 | 12506476 | Malaise | |
| 125064762 | 12506476 | Pulmonary arterial hypertension | |
| 125064762 | 12506476 | Valvuloplasty cardiac |
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 |
|---|---|---|---|---|---|---|
| 125064762 | 12506476 | 1 | 20100727 | 0 |