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Trial · NCT03324880

Outcomes29

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Subscale Score at Week 26Baseline, Week 26ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 26Baseline, Week 26ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Physical Component Summary (PCS) Derived From 36-Item Short Form Health Survey Version 2 (SF-36v2) Scores at Week 26Baseline, Week 26ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Impact Subscale Score at Week 26Baseline, Week 26ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Individual Hypoparathyroidism Symptom Diary (HypoPT-SD) Impact Items Score at Week 26Baseline, Week 26ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Item Anxiety (Item 8) Score at Week 26Baseline, Week 26ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Item Sadness or Depression (Item 9) Score at Week 26Baseline, Week 26ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Individual Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Item Scores at Week 26Baseline, Week 26ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.score on a scaleLEAST_SQUARES_MEAN
SECONDARYNumber of Participants With Response at Week 26 [Early Termination (ET)]Baseline up to Week 26ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange From Baseline in the Most Bothersome Symptom Score at Week 26Baseline, Week 26ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Perceived Cognitive Impairments (PCI) Score at Week 26Baseline, Week 26ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Impact on Quality of Life (QoL) Score at Week 26Baseline, Week 26ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Individual Domains of 36-Item Short Form Health Survey Version 2 (SF-36v2) at Week 26Baseline, Week 26
ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available analysis for specified categories.
score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Mental Component Summary (MCS) Score of 36-Item Short Form Health Survey Version 2 (SF-36v2) at Week 26Baseline, Week 26ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Work Productivity and Activity Impairment Questionnaire: Hypoparathyroidism (WPAI: Hypoparathyroidism) Score at Week 26Baseline, Week 26
ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses. Number analyzed is the number of participants with data available for analysis for specified categories.
score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Scores of Patient's Assessment of Overall Health Status Using Patient Global Impression of Severity (PGI-S) at Week 26Baseline, Week 26ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Scores of Patient's Assessment of Overall Health Status Using Patient Global Impression of Change (PGI-C) at Week 26Baseline, Week 26ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.score on a scaleMEAN
SECONDARYChange From Baseline in In-Clinic Neurocognitive Assessment Scores at Week 24Baseline, Week 24
ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses. Number analyzed is the number of participants with data available for analysis for specified categories.
score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in At-Home Neurocognitive Assessment Scores at Week 26Baseline, Week 26
ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses. Number analyzed is the number of participants with data available for analysis for specified categories.
score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in 24-hour Urine Calcium Excretion at Week 26Baseline, Week 26ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.millimoles per day (mmol/day)LEAST_SQUARES_MEAN

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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