Trial · NCT02435212
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Overall Compliance Using Stick Pack or Tablet Counts in Iron Chelation Therapy (ICT)-naïve Participants During the Core Phase | 24 weeks | The Full Analysis Set 1 (FAS-1) consisted of all ICT naive randomized participants during the core phase. | percentage of compliance | MEAN |
| PRIMARY | Change From Baseline in Serum Ferritin (SF) for Both Study Drug Formulations in ICT naïve Participants During the Core Phase | From Baseline to Week 25 | The Full Analysis Set 1 (FAS-1) consisted of all ICT naive randomized participants during the core phase. | μg/L | MEAN |
| SECONDARY | Percentage of Overall Compliance Using Stick Pack or Tablet Counts in ICT-naïve Participants During the Core Phase | 48 weeks | The Full Analysis Set 1 (FAS-1) consisted of all ICT naive randomized participants during the core phase. | percentage of compliance | MEAN |
| SECONDARY | Change From Baseline in Serum Ferritin (SF) for Both Study Drug Formulations in ICT naïve Participants During the Core Phase | From Baseline to 48 weeks | The Full Analysis Set 1 (FAS-1) consisted of all ICT naive randomized participants during the core phase. | μg/L | MEAN |
| SECONDARY | Change From Baseline in Serum Ferritin (SF) for Both Study Drug Formulations in Pre-treated Participants During the Core Phase | From Baseline to Week 25 and Week 48 | The Full Analysis Set 2 (FAS-2) consisted of all ICT pre-treated randomized participants during the core phase. | μg/L | MEAN |
| SECONDARY | Change Over-time in Domain Score of Modified Satisfaction With Iron Chelation Therapy (mSICT) Using Patient Reported Outcomes (PRO) Questionnaires | At Week 2, Week 3, Week 25 and Week 48 | The Full Analysis Set 3 (FAS-3) consisted of all randomized participants during the core phase. This includes only the participants aged between 10 years and less than 18 years with a valid assessment for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change Over-time in Domain Score of Modified Satisfaction With Iron Chelation Therapy (mSICT) Using Observer Reported Outcomes (ObsRO) Questionnaire (Caregiver's Perspective) | At Week 2, Week 3, Week 25 and Week 48 | The Full Analysis Set 3 (FAS-3) consisted of all randomized participants during the core phase. This includes only the participants aged between 2 years and less than 10 years with a valid assessment for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change Over-time in Domain Score of Modified Satisfaction With Iron Chelation Therapy (mSICT) Using Observer Reported Outcomes (ObsRO) Questionnaire (Child's Perspective) | At Week 2, Week 3, Week 25 and Week 48 | The Full Analysis Set 3 (FAS-3) consisted of all randomized participants during the core phase. This includes only the participants aged between 2 years and less than 10 years with a valid assessment for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change Over-time in Domain Score of Palatability Using Patient Reported Outcomes (PRO) Questionnaires | At Week 2, Week 3, Week 25 and Week 48 | The Full Analysis Set 3 (FAS-3) consisted of all randomized participants during the core phase. This includes only the participants aged between 10 years and less than 18 years with a valid assessment for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change Over-time in Domain Score of Palatability Using Observer Reported Outcomes (ObsRO) Questionnaire | At Week 2, Week 3, Week 25 and Week 48 | The Full Analysis Set 3 (FAS-3) consisted of all randomized participants during the core phase. This includes only the participants aged between 2 years and less than 10 years with a valid assessment for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change Over Time in Weekly Dose Violation Rate Using Compliance Patient Reported Outcomes (PRO) Questionnaire | At Week 1, Week 13, Week 25, Week 37 and Week 48 | The Full Analysis Set 3 (FAS-3) consisted of all randomized participants during the core phase. This includes only the participants aged between 10 years and less than 18 years with a valid assessment for this outcome measure. | percentage of days with dose violations | MEAN |
| SECONDARY | Change Over Time in Weekly Dose Violation Rate Using Compliance Observer Reported Outcomes (ObsRO) Questionnaire | At Week 1, Week 13, Week 25, Week 37 and Week 48 | The Full Analysis Set 3 (FAS-3) consisted of all randomized participants during the core phase. This includes only the participants aged between 2 years and less than 10 years with a valid assessment for this outcome measure. | percentage of days with dose violations | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Core Phase | From Baseline to 48 weeks | The Safety Set consisted of all participants who received at least 1 dose of study drug during the core phase. Three participants did not receive the study drug and hence were excluded from the safety set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pre-dose Concentrations of Deferasirox to Support the Assessment of Compliance | At Weeks 1, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, and 45 | Pharmacokinetic Analysis Set 1 (PAS-1) consisted of all participants who had at least one evaluable pre- or 3 hours post-dose PK concentration of deferasirox. The analysis included participants only with evaluable values. | μmol/L | GEOMETRIC_MEAN |
| SECONDARY | Concentrations of Deferasirox Between 2 and 4 Hours Post-dose at Weeks 5 and 9 | At Week 5 and Week 9 | Pharmacokinetic Analysis Set 1 (PAS-1) consisted of all participants who had at least one evaluable pre- or 3 hours post-dose PK concentration of deferasirox. The analysis included participants only with evaluable values. | μmol/L | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Entire Granule Period | From Baseline to 305 weeks | The Safety Set consisted of all participants who received at least 1 dose of granule formulation during the core or extension phase. The participants in the extension phase received granules regardless of which arm they were initially randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events of Special Interest (AESI) During the Entire Granule Period | From Baseline to 305 weeks | The Safety Set consisted of all participants who received at least 1 dose of granule formulation during the core or extension phase. The participants in the extension phase received granules regardless of which arm they were initially randomized. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Exposure-Response Relationship in Relation to Pre- and Post-Dose Deferasirox Concentrations (PK/PD Relationship) | From Baseline to 48 weeks |
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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