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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125774611 | 12577461 | 1 | I | 20160627 | 20160707 | 20160720 | 20160720 | PER | US-ACTELION-A-NJ2016-139204 | ACTELION | 58.00 | YR | A | M | Y | 0.00000 | 20160721 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125774611 | 12577461 | 1 | PS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 69 NG/KG, PER MIN | MM089M0101 | 22260 | INJECTION | /min | |||||||
| 125774611 | 12577461 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | U | U | 21290 | 125 | MG | TABLET | BID | ||||
| 125774611 | 12577461 | 3 | C | WARFARIN | WARFARIN | 1 | 10 MG, BID | U | 0 | 10 | MG | BID | |||||||
| 125774611 | 12577461 | 4 | C | METOLAZONE. | METOLAZONE | 1 | 5 MG, UNK | U | 0 | 5 | MG | ||||||||
| 125774611 | 12577461 | 5 | C | LANOXIN | DIGOXIN | 1 | 250 MCG, QD | U | 0 | 250 | UG | QD | |||||||
| 125774611 | 12577461 | 6 | C | ALBUTEROL. | ALBUTEROL | 1 | 2 PUFF, Q6HRS | U | 0 | QID | |||||||||
| 125774611 | 12577461 | 7 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | 2000 U, QD | U | 0 | QD | |||||||||
| 125774611 | 12577461 | 8 | C | OS-CAL + D | 2 | Oral | 500MG-200U, BID | U | 0 | BID | |||||||||
| 125774611 | 12577461 | 9 | C | VITAMIN D2 | ERGOCALCIFEROL | 1 | 50000 U, Q1WEEK | U | 0 | /wk | |||||||||
| 125774611 | 12577461 | 10 | C | TAPAZOLE | METHIMAZOLE | 1 | 5 MG, QD | U | 0 | 5 | MG | QD | |||||||
| 125774611 | 12577461 | 11 | C | ALDACTONE | SPIRONOLACTONE | 1 | 50 MG, BID | U | 0 | 50 | MG | BID | |||||||
| 125774611 | 12577461 | 12 | C | LASIX | FUROSEMIDE | 1 | 40 MG, UNK | U | 0 | 40 | MG | ||||||||
| 125774611 | 12577461 | 13 | C | ULTRAM | TRAMADOL HYDROCHLORIDE | 1 | 50 MG, PRN | U | 0 | 50 | MG | ||||||||
| 125774611 | 12577461 | 14 | C | K-TAB | POTASSIUM CHLORIDE | 1 | 10 MEQ, BID | U | 0 | 10 | MEQ | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125774611 | 12577461 | 1 | Pulmonary hypertension |
| 125774611 | 12577461 | 2 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125774611 | 12577461 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125774611 | 12577461 | Abdominal distension | |
| 125774611 | 12577461 | Brain natriuretic peptide increased | |
| 125774611 | 12577461 | Dyspnoea | |
| 125774611 | 12577461 | Oedema peripheral |
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 |
|---|---|---|---|---|---|---|
| 125774611 | 12577461 | 1 | 20101101 | 0 |