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Trial · NCT02258542

Outcomes42

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI PatientsWeek 56Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.10^9 cells/LMEAN
PRIMARYChange From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)Week 108
Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.
10^9 cells/LMEAN
PRIMARYChange From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI PatientsWeek 56Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.10^9 cells/LMEAN
PRIMARYChange From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)Week 108
Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.
10^9 cells/LMEAN
PRIMARYChange From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI PatientsWeek 56Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.10^9 cells/LMEAN
PRIMARYChange From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)Week 108
Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.
10^9 cells/LMEAN
PRIMARYChange From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI PatientsWeek 56Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.10^9 cells/LMEAN
PRIMARYChange From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)Week 108
Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.
10^9 cells/LMEAN
PRIMARYChange From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI PatientsWeek 56Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.10^9 cells/LMEAN
PRIMARYChange From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)Week 108
Full analysis set, adolescents only(studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.
10^9 cells/LMEAN
PRIMARYChange From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI PatientsWeek 56Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.ukat/LMEAN
PRIMARYChange From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)Week 108
Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.
ukat/LMEAN
PRIMARYChange From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI PatientsWeek 56Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.ukat/LMEAN
PRIMARYChange From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)Week 108
Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.
ukat/LMEAN
PRIMARYChange From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI PatientsWeek 56Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.umol/LMEAN
PRIMARYChange From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)Week 108
Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.
umol/LMEAN
SECONDARYNumber of Overall Patients With Asthma Exacerbations During Study PeriodFrom week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose)
Full analysis set, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count \>=300/uL or \<300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA)From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose)
Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count \>=300/uL or \<300/uL; separated by predecessor treatment groups.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange From Baseline in Pre-bronchodilator FEV1 (L)Week 56
Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count\>=300/uL, and \<300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups.
LMEAN
SECONDARYChange From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)Week 108
Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count \>=300/uL or \<300/uL; separated by predecessor treatment groups.
LMEAN

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.

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