Trial · NCT05073458
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Attaining a Durable Hemoglobin Response | up to Week 24 | Safety Analysis Set: all randomized participants who received at least 1 dose of study drug. Treatment groups were determined according to the actual treatment the participant received on Day 1 regardless of assigned study treatment. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a ≥3-point Increase From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 24 | Baseline; Week 24 | Safety Analysis Set. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a 50 Meter Increase From Baseline to Week 24 in a 6-minute Walk Test (6MWT) | Baseline; Week 24 | Safety Analysis Set. Only participants with available data were analyzed, | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit | Baseline; Day 1; Weeks 8, 12, 16, 20, 24, 28, 32, 40, 48, 56, and every 16 weeks post-Week 56 | Safety Analysis Set. Only participants with available data were analyzed. | scores on a scale | MEAN |
| SECONDARY | Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit | Baseline; Day 1; Weeks 8, 12, 16, 20, 24, 28, 32, 40, 48, 56, and every 16 weeks post-Week 56 | Safety Analysis Set. Only participants with available data were analyzed, | percentage change | MEAN |
| SECONDARY | Change From Baseline in Hemoglobin at Each Post-Baseline Visit | Baseline; Day 1; Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and every 8 weeks post-Week 56 | Safety Analysis Set. Only participants with available data were analyzed. | grams per liter | MEAN |
| SECONDARY | Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit | Baseline; Day 1; Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and every 8 weeks post-Week 56 | Safety Analysis Set. Only participants with available data were analyzed. | percentage change | MEAN |
| SECONDARY | Percentage of Participants Who Received Transfusions From Week 6 to Week 24 and From Week 24 to Week 48 | Week 6 to Week 24; Week 24 to Week 48 | Safety Analysis Set. Only participants with available data were analyzed. The number of participants analyzed at Weeks 6 to 24 reflects the number of participants who received study drug for at least 43 days. The number of participants analyzed at Weeks 24 to 48 reflects the number of participants who received study drug during the open-label period. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Daily Corticosteroid Dose at Week 24 | Baseline; Week 24 | Safety Analysis Set. Only participants with available data were analyzed. | milligrams | MEAN |
| SECONDARY | Percentage Change From Baseline in Daily Corticosteroid Dose at Week 24 | Baseline; Week 24 | Safety Analysis Set. Only participants with available data were analyzed. | percentage change | MEAN |
| SECONDARY | Percentage of Participants Who Required Rescue Therapy at Any Visit From Week 6 Through Week 24, and From Week 24 to Week 48 | Week 6 to Week 24; Week 24 to Week 48 | Safety Analysis Set. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to 446 days | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any ≥Grade 3 TEAE | up to 446 days | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
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.
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GET https://conductscience.org/api/trials/v1/NCT05073458/outcomes