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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125609631 | 12560963 | 1 | I | 20160711 | 0 | 20160714 | 20160714 | DIR | 66.00 | YR | M | N | 0.00000 | 20160713 | Y | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125609631 | 12560963 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | D | D | OP023P0101 | 20201231 | 0 | 125 | MG | BID | ||||
| 125609631 | 12560963 | 3 | C | ALBUTEROL. | ALBUTEROL | 1 | 0 | ||||||||||||
| 125609631 | 12560963 | 5 | C | MORPHINE | MORPHINE | 1 | 0 | ||||||||||||
| 125609631 | 12560963 | 7 | C | LORAZEPAM. | LORAZEPAM | 1 | 0 | ||||||||||||
| 125609631 | 12560963 | 9 | C | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 0 | ||||||||||||
| 125609631 | 12560963 | 11 | C | ENOXAPARIN | ENOXAPARIN | 1 | 0 | ||||||||||||
| 125609631 | 12560963 | 13 | C | FUROSEMIDE. | FUROSEMIDE | 1 | 0 | ||||||||||||
| 125609631 | 12560963 | 15 | C | KCL | POTASSIUM CHLORIDE | 1 | 0 | ||||||||||||
| 125609631 | 12560963 | 17 | C | TRAMADOL. | TRAMADOL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125609631 | 12560963 | 1 | Connective tissue disorder |
| 125609631 | 12560963 | 1 | Cor pulmonale chronic |
| 125609631 | 12560963 | 1 | Heart disease congenital |
| 125609631 | 12560963 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125609631 | 12560963 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125609631 | 12560963 | Abdominal distension | |
| 125609631 | 12560963 | Lethargy | |
| 125609631 | 12560963 | Oedema peripheral | |
| 125609631 | 12560963 | Respiratory distress | |
| 125609631 | 12560963 | Rhonchi | |
| 125609631 | 12560963 | Sepsis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 125609631 | 12560963 | HP |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125609631 | 12560963 | 1 | 201411 | 201506 | 0 |