Trial · NCT01030718
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation | baseline; every 4 weeks (if on study < 6 months, including CA180-031(NCT00337454); every 12 weeks (if on study >=6 months and <=2 years); every 24 weeks (if on study >2 years); at discontinuation | All treated participants. Number of deaths represents all reported deaths, including after the study end. For AEs leading to discontinuation: 4 in CML-CP=1 insufficient effect (IE) +3 AEs in Participant Flow (PF); 7 in CML-AP/BP= 1 death + 5 AEs + 1 IE in PF; 4 in Ph+ALL=3 IE + 1AE in PF. | participants | NUMBER |
| SECONDARY | Participants With Chronic Phase CML (CML-CP): Percentage of Participants With Cytogenetic Response | At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454) | Treated CML-CP participants | Percentage of Participants | NUMBER |
| SECONDARY | Participants With CML-Accelerated or Blast Phase (AP/BP): Percentage of Participants With Cytogenetic Response | At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter | Treated CML-AP/BP participants | Percentage of Participants | NUMBER |
| SECONDARY | Participants With Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL): Percentage of Participants With Cytogenetic Response | At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter | Treated Ph+ ALL participants | Percentage of Participants | NUMBER |
| SECONDARY | Participants With CML-CP: Time to Complete Cytogenetic Response (CCyR) | At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454), | Participants achieving CCyR | Days | MEDIAN |
| SECONDARY | Participants With CML-AP/BP and Ph+ ALL: Time to Complete Cytogenetic Response (CCyR) | At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter | Participants achieving CCyR | Days | MEDIAN |
| SECONDARY | Participants With CML-CP: Duration of Complete Cytogenetic Response (CCyR) | At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454) | Participants achieving CCyR. Median duration of CCyR was not yet reached in the CML-CP group. | Days | MEDIAN |
| SECONDARY | Participants With CML-AP/BP and Ph+ALL: Duration of Complete Cytogenetic Response (CCyR) | At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter | Participants achieving CCyR. Median duration of CCyR was not yet reached in the CML-AP/BP group. | Days | MEDIAN |
| SECONDARY | Participants With CML-CP: Time to Major Cytogenetic Response (MCyR) | At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454) | Time to MCyR was computed only for participants whose best response was CCyR or PCyR. | Days | MEDIAN |
| SECONDARY | Participants With CML-AP/BP and Ph+ALL: Time to Major Cytogenetic Response (MCyR) | At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter | Time to MCyR was computed only for participants whose best response was CCyR or PCyR. | Days | MEDIAN |
| SECONDARY | Participants With CML-CP: Duration of Major Cytogenetic Response (MCyR) | At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454) | Duration of MCyR was computed for subjects whose best response was either CCyR or PCyR. Median duration of MCyR was not yet reached in the CML-CP arm. | Days | MEDIAN |
| SECONDARY | Participants With CML-AP/BP and Ph+ ALL: Duration of Major Cytogenetic Response (MCyR) | At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter | Duration of MCyR was computed for subjects whose best response was either CCyR or PCyR. Median duration of MCyR was not yet reached in the CML-AP/BP arm. | Days | MEDIAN |
| SECONDARY | Participants With CML-CP: Percentage of Participants With Complete Hematologic Response (CHR) | baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454), every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation | Treated CML-CP participants | Percentage of Participants | NUMBER |
| SECONDARY | Participants With CML-AP/BP: Percentage of Participants With Hematologic Response | baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation | Treated CML-AP/BP participants | Percentage of Participants | NUMBER |
| SECONDARY | Participants With Ph+ ALL: Percentage of Participants With Hematologic Response | baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation | Treated Ph+ ALL participants | Percentage of Participants | NUMBER |
| SECONDARY | Time to Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL | baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation | Participants achieving CHR | Days | MEDIAN |
| SECONDARY | Duration of Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL | baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation | Participants achieving CHR. Duration of CHR in the CML AP/BP arm has not yet been reached. | Days | MEDIAN |
| SECONDARY | Time to Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL | baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation | Participants achieving MaHR | Days | MEDIAN |
| SECONDARY | Duration of Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL | baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation | Duration of MaHR was computed only for advanced diseases subjects whose best response is a MaHR and was measured from the first day MaHR criteria are met, provided they were confirmed 28 days later until the date of PD or death. Median Duration of MaHR was not yet reached in the CML-AP/BP arm. | Days | MEDIAN |
| SECONDARY | Time to Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL | baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation | OHR was computed only for subjects whose best response is CHR or MaHR or Minor HR (MiHR). | Days | MEDIAN |
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
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