Trial · NCT03604198
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Long-term safety of relacorilant | 36 months | Number of patients with treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 or higher |
| Other | Number of patients with one or more hematology laboratory abnormality by severity grade | Up to Month 99 | The hematology laboratory abnormalities to be assessed are hemoglobin decreased, hemoglobin increased, platelet count decreased, white blood cell count decreased, leukocytosis, eosinophilia, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased. The laboratory abnormalities will be reported by worst grade of mild, moderate, severe, or life-threatening, using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, version 4 or higher) criteria. |
| Other | Number of patients with one or more clinical chemistry laboratory abnormality by severity grade | Up to Month 99 | The clinical chemistry laboratory abnormalities to be assessed are hypoalbuminemia, alkaline phosphatase increased, alanine aminotransferase increased, aspartate aminotransferase increased, hypocalcemia, hypercalcemia, creatine increased, hypoglycemia, hyperglycemia, blood lactate dehydrogenase increased, hypomagnesemia, hypermagnesemia, hypokalemia, hyperkalemia, hyponatremia, hypernatremia, creatine phosphokinase increased, blood bilirubin increased, and hyperuricemia. The laboratory abnormalities will be reported by worst grade of mild, moderate, severe, or life-threatening, using the CTCAE, version 4 or higher criteria. |
| Other | Change from Baseline in oral body temperature | Baseline and up to Month 99 | |
| Other | Change from Baseline in respiratory rate | Baseline and up to Month 99 | |
| Other | Change from Baseline in blood pressure | Baseline and up to Month 99 | Systolic and diastolic blood pressure will be assessed. |
| Other | Change from Baseline in heart rate | Baseline and up to Month 99 | |
| Other | Change from Baseline in electrocardiogram (ECG) parameters | Baseline and Month 3 | 12-lead ECGs will be performed in duplicate and will be evaluated by a central reviewer. The parameters to be assessed are PR interval, QRS interval, QT interval, RR interval, QTcF interval, and QTcB interval. |
| Other | Change from Baseline in ECG ventricular rate | Baseline and Month 3 | 12-lead ECGs will be performed in duplicate and will be evaluated by a central reviewer. |
| Other | Change from Baseline in the longest vertical diameter of pituitary tumors as determined with magnetic resonance imaging (MRI) | Baseline and up to Month 72 | Pituitary MRI imaging will be used to assess changes in tumor size during dosing. A computed tomography (CT) scan can be used in patients for whom MRI is contraindicated. |
| Other | Change from baseline in the volume of pituitary tumors as determined with MRI | Baseline and up to Month 72 | Pituitary MRI imaging will be used to assess changes in tumor size during dosing. A CT scan can be used in patients for whom MRI is contraindicated. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03604198/registered