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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126048082 | 12604808 | 2 | F | 20160707 | 20160729 | 20160728 | 20160810 | PER | US-ACTELION-A-US2016-139531 | ACTELION | 82.00 | YR | E | F | Y | 0.00000 | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126048082 | 12604808 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP023P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 126048082 | 12604808 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | 21290 | 62.5 | MG | TABLET | BID | ||||||
| 126048082 | 12604808 | 3 | C | DIGOXIN. | DIGOXIN | 1 | 125 MG, QOD | U | 0 | 125 | MG | ||||||||
| 126048082 | 12604808 | 4 | C | ALBUTEROL. | ALBUTEROL | 1 | 2.5 MG, TID PRN | U | 0 | 2.5 | MG | TID | |||||||
| 126048082 | 12604808 | 5 | C | ALBUTEROL. | ALBUTEROL | 1 | U | 0 | |||||||||||
| 126048082 | 12604808 | 6 | C | DILTIAZEM. | DILTIAZEM | 1 | 180 MG, Q8HRS | U | 0 | 180 | MG | ||||||||
| 126048082 | 12604808 | 7 | C | APIXABAN | APIXABAN | 1 | 2.5 MG, BID | U | 0 | 2.5 | MG | BID | |||||||
| 126048082 | 12604808 | 8 | C | SILDENAFIL. | SILDENAFIL | 1 | 80 MG, TID | U | 0 | 80 | MG | TID | |||||||
| 126048082 | 12604808 | 9 | C | FAMOTIDINE. | FAMOTIDINE | 1 | 40 MG, QD | U | 0 | 40 | MG | QD | |||||||
| 126048082 | 12604808 | 10 | C | POTASSIUM CHLORIDE. | POTASSIUM CHLORIDE | 1 | 10 MEQ, BID | U | 0 | 10 | MEQ | BID | |||||||
| 126048082 | 12604808 | 11 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Intravenous (not otherwise specified) | 40 MG, BID | U | 0 | 40 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126048082 | 12604808 | 1 | Pulmonary hypertension |
| 126048082 | 12604808 | 4 | Pulmonary congestion |
| 126048082 | 12604808 | 5 | Dyspnoea |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126048082 | 12604808 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126048082 | 12604808 | Acute respiratory failure | |
| 126048082 | 12604808 | Alanine aminotransferase increased | |
| 126048082 | 12604808 | Aspartate aminotransferase increased | |
| 126048082 | 12604808 | Blood alkaline phosphatase increased | |
| 126048082 | 12604808 | Blood bilirubin increased | |
| 126048082 | 12604808 | Cardiac failure acute | |
| 126048082 | 12604808 | Dyspnoea | |
| 126048082 | 12604808 | Liver function test increased | |
| 126048082 | 12604808 | Oedema | |
| 126048082 | 12604808 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 126048082 | 12604808 | 1 | 201502 | 0 | ||
| 126048082 | 12604808 | 2 | 201501 | 201502 | 0 |