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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127465732 | 12746573 | 2 | F | 20160908 | 20160915 | 20160920 | EXP | US-ACTELION-A-NJ2016-136434 | ACTELION | 8.00 | MON | I | F | Y | 0.00000 | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127465732 | 12746573 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 1 MG/KG, BID | N | 21290 | 1 | MG/KG | TABLET | BID | |||||
| 127465732 | 12746573 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 10.625 MG, QD | N | 21290 | 10.625 | MG | TABLET | QD | |||||
| 127465732 | 12746573 | 3 | SS | TRACLEER | BOSENTAN | 1 | Oral | 15.625 MG, BID | N | 21290 | 15.625 | MG | TABLET | BID | |||||
| 127465732 | 12746573 | 4 | C | LASIX | FUROSEMIDE | 1 | 5 MG, Q6HRS | N | 0 | 5 | MG | QID | |||||||
| 127465732 | 12746573 | 5 | C | REGLAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | UNK | N | 0 | ||||||||||
| 127465732 | 12746573 | 6 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | 5 MG, Q6HRS | 0 | 5 | MG | QID | ||||||||
| 127465732 | 12746573 | 7 | C | DIURIL | CHLOROTHIAZIDE | 1 | 45 MG, Q6HRS | 0 | 45 | MG | QID | ||||||||
| 127465732 | 12746573 | 8 | C | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 1 | 40 MG, UNK | 0 | 40 | MG | |||||||||
| 127465732 | 12746573 | 9 | C | DIGOXIN. | DIGOXIN | 1 | 8 MG, BID | 0 | 8 | MG | BID | ||||||||
| 127465732 | 12746573 | 10 | C | LOVENOX | ENOXAPARIN SODIUM | 1 | Subcutaneous | 7 MG, Q12HRS | 0 | 7 | MG | BID | |||||||
| 127465732 | 12746573 | 11 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 20.25 MG, QD | 0 | 20.25 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127465732 | 12746573 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127465732 | 12746573 | HO |
| 127465732 | 12746573 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127465732 | 12746573 | Bradycardia | |
| 127465732 | 12746573 | Cardiac arrest | |
| 127465732 | 12746573 | Hypotension | |
| 127465732 | 12746573 | Right ventricular systolic pressure increased | |
| 127465732 | 12746573 | Therapy non-responder |
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 |
|---|---|---|---|---|---|---|
| 127465732 | 12746573 | 1 | 20160311 | 0 | ||
| 127465732 | 12746573 | 2 | 20160311 | 20160319 | 0 | |
| 127465732 | 12746573 | 3 | 20160311 | 20160511 | 0 | |
| 127465732 | 12746573 | 4 | 20160331 | 20160516 | 0 | |
| 127465732 | 12746573 | 5 | 20160331 | 20160516 | 0 | |
| 127465732 | 12746573 | 6 | 20160331 | 20160516 | 0 | |
| 127465732 | 12746573 | 7 | 20160331 | 20160516 | 0 | |
| 127465732 | 12746573 | 8 | 20160331 | 20160516 | 0 | |
| 127465732 | 12746573 | 9 | 20160331 | 20160516 | 0 | |
| 127465732 | 12746573 | 10 | 20160331 | 20160516 | 0 | |
| 127465732 | 12746573 | 11 | 20160331 | 20160516 | 0 |