Trial · NCT03605212
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetic (PK) Parameter: Apparent Clearance (CL/F) | 7 days | Apparent clearance of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) |
| Primary | PK Parameter: Apparent Volume of Distribution (Vd/F) | 7 days | Apparent volume of distribution of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) |
| Primary | PK Parameter: Absorption Rate Constant (Ka) | 7 days | Absorption rate constant of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) |
| Primary | PK Parameter: Area Under Curve (AUC) | 7 days | AUC of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) |
| Primary | PK Parameter: Maximum Plasma Concentration (Cmax) | 7 days | Maximum plasma concentration of febuxostat from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) |
| Primary | PK Parameter: Tmax | 7 days | Time to Cmax from Visit 2 (Day 2) to Evaluation Visit (Visit 8, Day 8) |
| Secondary | Pharmacodynamic (PD) Parameter: Area Under the Curve of Serum Uric Acid (sUA) | 8 days | Area under the curve of sUA from baseline (Visit 1, Day 1) to the Evaluation Visit (Visit 8, Day 8) (AUC sUA 1-8) |
| Secondary | Assessment of Laboratory Tumor Lysis Syndrome (LTLS) | 7 days | Assessment of LTLS at Visit 1 (Day 1) and from Start of Chemotherapy (Visit 3, Day 3) to the Evaluation Visit (Visit 8, Day 8). LTLS is diagnosed if levels of 2 or more values of uric acid, potassium, phosphate or calcium are more than or less than normal at presentation or if they change by at least 25% from baseline. |
| Secondary | Assessment of Clinical Tumor Lysis Syndrome (CTLS) | 7 days | Assessment of CTLS at Visit 1 (Day 1) and from Start of Chemotherapy (Visit 3, Day 3) to the Evaluation Visit (Visit 8, Day 8). CTLS is present when LTLS is accompanied by at least one of the following significant clinical complications: increased creatinine level ≥ 1.5 upper limit of normal, cardiac arrhythmia/sudden death or seizure. |
| Secondary | Assessment of Treatment Emergent Signs and Symptoms (TESS) | Estimated maximum time frame: 27 days | Assessment of incidence, severity (through Mild/Moderate/Severe scale), seriousness and treatment-causality of TESS from Screening Visit to End of Study Visit. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. An adverse event was considered as TESS if it occured for the first time or if it worsened in terms of seriousness or severity after first study drug intake. |
| Secondary | Assessment of Participants Affected by Treatment Emergent Signs and Symptoms (TESS) | Estimated maximum time frame: 27 days | Number of participants affected by TESS from Screening Visit to End of Study Visit. |
| Secondary | Performance Status (PS) Evaluation | Estimated maximum time frame: 27 days | Quality of life was to be assessed by PS evaluation from Screening Visit to End of Study Visit. The Karnofsky Performance Status (KPS) scale was to be used for patients aged 16 years and older; the Lansky Play Performance Status (LPS) scale was to be used for patients aged less than 16 years. Both scales range from scores of 0 to 100 points at intervals of 10 where 0 points represent the worst outcome (KPS: 0 = death; LPS: 0 = unresponsive) and 100 points the best (KPS: 100 = normal, no complaints, no evidence of disease; LPS: 100 = fully active). |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT03605212/registered