Trial · NCT01421069
Outcomes80
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 80
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Malignancy: All Periods of Parent and Extension Study | First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study) | Analysis population included all participants who were enrolled in the parent and extension study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Events: All Periods of Parent and Extension Study | First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study) | Analysis population included all participants who were enrolled in the parent and extension study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Infections: All Periods of Parent and Extension Study | First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study) | Analysis population included all participants who were enrolled in the parent and extension study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Medically Important Infections: All Periods of Parent and Extension Study | First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study) | Analysis population included all participants who were enrolled in the parent and extension study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Infections: All Periods of Parent and Extension Study | First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study) | Analysis population included all participants who were enrolled in the parent and extension study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Infections and Injection Site Reactions: All Periods of Extension Study | Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months) | Analysis population included all participants who were enrolled in the extension study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Infections: Extension Study: Withdrawal Period | Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months) | Withdrawal analysis set (WAS) included those participants who entered the withdrawal period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Withdrawn Due to Adverse Events: All Periods of Parent and Extension Study | First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study) | Analysis population included all participants who were enrolled in the parent and extension study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Withdrawn Due to Adverse Events: Extension Study: Withdrawal Period | Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months) | WAS included those participants who entered the withdrawal period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities Based on National Cancer Institute Criteria Version 4.03: All Periods of Extension Study | Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months) | Analysis population included all participants who were enrolled in the extension study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline of Parent Study in Z-Score at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Active Treatment Period | Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study | FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points. | z-score | MEAN |
| SECONDARY | Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Withdrawal Period | Baseline of the extension study; Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 withdrawal period of extension study | WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points. | z-score | MEAN |
| SECONDARY | Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Re-treatment Period | Baseline of the extension study; Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 re-treatment period of extension study | Re-treatment analysis set (RTAS) included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points. | z-score | MEAN |
| SECONDARY | Change From Baseline (of Parent Study) in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Active Treatment Period | Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study | FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Withdrawal Period | Baseline of the extension study; Month 12, 24, 36, 48, 60, 72, 84 and 96 withdrawal period of extension study | WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Re-treatment Period | Baseline of the extension study; Month 12, 24, 36, 48, 60, 72, 84 and 96 re-treatment period of extension study | RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points. | Units on a scale | MEAN |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 of Extension Study: Active Treatment Period | Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study | FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period | Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study | WAS included participants who entered the withdrawal period. Here, number analyzed signifies participants evaluable at specified time points. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period: | Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study | RTAS included those participants who entered the re-treatment period. Here, number analyzed signifies participants evaluable at specified time points. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period | Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study | FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, number analyzed signifies participants evaluable at specified time points. | Percentage of participants | NUMBER |
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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