Trial · NCT04643002
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 31 of 31
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | The intensity of skeletal-related events (SRE)- related bone pain will be assessed using the skeletal-related bone pain numeric rating scale (SRE-BP-NRS) for control and experimental arms -Substudy 02 | On Day1 Cycle 1, then every 2 cycles for the first year; then every 3 cycles thereafter, at end of treatment and at first follow-up visit. The cycle is 28 days. | The SRE-BP-NRS) will be used to assess the intensity of SRE-related bone pain (on average and at its worst) for control arm only |
| Secondary | SRE Incidence for control and experimental arms- Substudy 02 | Continuous throughout study assessment (up to approximately 28 months) | SRE incidence, defined as the proportion of participants who experienced pathological fracture, radiation to bone, spinal cord compression, or surgery to bone as a first bone event. |
| Secondary | Time to First Occurrence of SRE Assessment for control and experimental arms (Substudy 02) | Continuous throughout study assessment (up to approximately 28 months) | Time to first occurrence of SRE is defined as time from the date of randomization to the occurrence of first SRE. |
| Secondary | Assessment of Health care resource utilization related with SREs for control and experimental arms -Substudy 02 | On Day1 Cycle 1, then every 2 cycles for the first year; then every 3 cycles thereafter, at End of treatment and at first follow-up visit. The cycle is 28 days. | The Health Care Resource Use-SREs questionnaire (HCRU-SREs) will be used to assess the use of health care resources associated with these events. |
| Secondary | To assess patient-reported visual functioning for experimental arm only -Substudy 03 | On Day1 Cycle 1, End of treatment and at first follow-up visit. The cycle is 28 days. | An NEI VFQ-25 will be used to assess patient-reported visual functioning. |
| Secondary | Maximum concentration observed after the first infusion (Cmax) for Belumosudil - Substudy 05 | Multiple timepoints during Cycle 1. The cycle is 28 days. | |
| Secondary | Time to reach Cmax (tmax) for Belumosudil - Substudy 05 | Multiple timepoints during Cycle 1. The cycle is 28 days. | |
| Secondary | Area under the concentration versus time curve calculated using the trapezoidal method from 0 to 8h (AUC0-8h) for Belumosudil - Substudy 05 | Multiple timepoints during Cycle 1. The cycle is 28 days. | |
| Secondary | Maximum concentration observed after the first infusion (Cmax) for Evorpacept - Substudy 06 | Multiple timepoints during Cycle 1. The cycle is 28 days. | |
| Secondary | Time to reach Cmax (tmax) for Evorpacept - Substudy 06 | Multiple timepoints during Cycle 1. The cycle is 28 days. | |
| Secondary | Area under the concentration versus time curve calculated using the trapezoidal method over the dosing interval for evorpacept (AUC0-t)- Substudy 06 | Multiple timepoints during Cycle 1. The cycle is 28 days. |
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/NCT04643002/registered?page=2