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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125903311 | 12590331 | 1 | I | 20160713 | 20160725 | 20160725 | EXP | US-ACTELION-A-US2016-139528 | ACTELION | 66.00 | YR | E | M | Y | 0.00000 | 20160726 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125903311 | 12590331 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP023P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 125903311 | 12590331 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | OP023P0101 | 21290 | 62.5 | MG | TABLET | BID | |||||
| 125903311 | 12590331 | 3 | C | ALBUTEROL. | ALBUTEROL | 1 | 2.5 MG, Q4HR, PRN | U | 0 | 2.5 | MG | ||||||||
| 125903311 | 12590331 | 4 | C | MORPHINE | MORPHINE | 1 | 5 MG, Q1HR, PRN | U | 0 | 5 | MG | ||||||||
| 125903311 | 12590331 | 5 | C | LORAZEPAM. | LORAZEPAM | 1 | 0.5 MG, Q4HR, PRN | U | 0 | .5 | MG | ||||||||
| 125903311 | 12590331 | 6 | C | LORAZEPAM. | LORAZEPAM | 1 | U | 0 | |||||||||||
| 125903311 | 12590331 | 7 | C | LORAZEPAM. | LORAZEPAM | 1 | U | 0 | |||||||||||
| 125903311 | 12590331 | 8 | C | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 10/325MG, Q4HR, PRN | U | 0 | ||||||||||
| 125903311 | 12590331 | 9 | C | ENOXAPARIN | ENOXAPARIN | 1 | 100 MG, QD | U | 0 | 100 | MG | QD | |||||||
| 125903311 | 12590331 | 10 | C | FUROSEMIDE. | FUROSEMIDE | 1 | 20 MG, QD | U | 0 | 20 | MG | QD | |||||||
| 125903311 | 12590331 | 11 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | 10 MEQ, QD | U | 0 | 10 | MEQ | QD | |||||||
| 125903311 | 12590331 | 12 | C | TRAMADOL. | TRAMADOL | 1 | 100 MG, Q6HR, PRN | U | 0 | 100 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125903311 | 12590331 | 1 | Pulmonary hypertension |
| 125903311 | 12590331 | 3 | Dyspnoea |
| 125903311 | 12590331 | 4 | Dyspnoea |
| 125903311 | 12590331 | 5 | Dyspnoea |
| 125903311 | 12590331 | 6 | Anxiety |
| 125903311 | 12590331 | 7 | Insomnia |
| 125903311 | 12590331 | 8 | Pain |
| 125903311 | 12590331 | 12 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125903311 | 12590331 | DE |
| 125903311 | 12590331 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125903311 | 12590331 | Abdominal distension | |
| 125903311 | 12590331 | Bilevel positive airway pressure | |
| 125903311 | 12590331 | Dyspnoea | |
| 125903311 | 12590331 | Lethargy | |
| 125903311 | 12590331 | Oedema peripheral | |
| 125903311 | 12590331 | Respiratory distress | |
| 125903311 | 12590331 | Rhonchi | |
| 125903311 | 12590331 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 125903311 | 12590331 | 1 | 201504 | 20160711 | 0 | |
| 125903311 | 12590331 | 2 | 201411 | 201504 | 0 |