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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123023616 | 12302361 | 6 | F | 20160413 | 20160920 | 20160425 | 20160930 | EXP | US-ACTELION-A-NJ2016-134932 | ACTELION | 70.00 | YR | E | M | Y | 0.00000 | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123023616 | 12302361 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP019P0101,OP026P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 123023616 | 12302361 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP019P0101, OP021P0101;OP026P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 123023616 | 12302361 | 3 | C | LOVENOX | ENOXAPARIN SODIUM | 1 | U | 0 | |||||||||||
| 123023616 | 12302361 | 4 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | U | 0 | |||||||||||
| 123023616 | 12302361 | 5 | C | ASPIRIN. | ASPIRIN | 1 | U | 0 | |||||||||||
| 123023616 | 12302361 | 6 | C | ZENPEP | PANCRELIPASE AMYLASEPANCRELIPASE LIPASEPANCRELIPASE PROTEASE | 1 | U | 0 | |||||||||||
| 123023616 | 12302361 | 7 | C | LASIX | FUROSEMIDE | 1 | U | 0 | |||||||||||
| 123023616 | 12302361 | 8 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | U | 0 | |||||||||||
| 123023616 | 12302361 | 9 | C | DIGOXIN. | DIGOXIN | 1 | U | 0 | |||||||||||
| 123023616 | 12302361 | 10 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | U | 0 | |||||||||||
| 123023616 | 12302361 | 11 | C | FOLVITE | FOLIC ACID | 1 | U | 0 | |||||||||||
| 123023616 | 12302361 | 12 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123023616 | 12302361 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123023616 | 12302361 | OT |
| 123023616 | 12302361 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123023616 | 12302361 | Ascites | |
| 123023616 | 12302361 | Blood alkaline phosphatase increased | |
| 123023616 | 12302361 | Blood pressure increased | |
| 123023616 | 12302361 | Cardiac disorder | |
| 123023616 | 12302361 | Chest pain | |
| 123023616 | 12302361 | Dyspnoea | |
| 123023616 | 12302361 | Fluid retention | |
| 123023616 | 12302361 | Gastrointestinal disorder | |
| 123023616 | 12302361 | Right ventricular failure |
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 |
|---|---|---|---|---|---|---|
| 123023616 | 12302361 | 1 | 20101104 | 0 |