Trial · NCT00529763
Dasatinib in Imatinib Resistant/Intolerant Chinese CML (Chronic and Advanced Phase) Subjects
NCT00529763, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2011-04-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dasatinib in Imatinib Resistant/Intolerant Chinese CML (Chronic and Advanced Phase) Subjects. Trials, record NCT00529763. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00529763
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib in Imatinib Resistant/Intolerant Chinese CML (Chronic and Advanced Phase) Subjects
- NCT number
- NCT00529763
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 121 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Leukemia
- Interventions
- Dasatinib
- First posted
- 2007-09-14
- Last updated
- 2023-05-08
- Results first posted
- 2011-04-05
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Major Cytogenetic Response (MCyR) | From first dose up to approximately 12 months of follow up after dasatinib treatment (data cut-off date: 18-Jun-2010) | Major Cytogenetic Response (MCyR) is defined as Complete Cytogenetic Response (CCyR) or Partial Cytogenetic Response (PCyR). CCyR: 0% Ph-chromosome-positive cells in metaphase in bone marrow \[BM\] PCyR: 1-35% Ph-chromosome-positive cells in metaphase in \[BM\]. |
| Primary | Percentage of Participants With Complete, Major, and Overall Hematologic Response (CHR, MaHR, & OHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Blast Phase CML/Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) | From first dose up to approximately 12 months of follow up after dasatinib treatment (data cut-off date: 18-Jun-2010) | Major hematologic response: (MaHR) = complete hematologic response (CHR) + no evidence of leukemia (NEL). CHR=white blood cells (WBC) ≤upper limit of normal (ULN); absolute neutrophil count (ANC) ≥1,000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes, \<20% basophils \& \<5% myelocytes+metamyelocytes in peripheral blood (PB); BM blasts ≤5%; no extra-medullary involvement/hepatomegaly/splenomegaly. NEL=CHR except platelets ≥20,000/mm3 \& \<100,000/mm3; ANC \>500/mm3 \& \<1,000/mm3. Overall hematologic response (OHR)=CHR+NEL+ return to chronic phase (RTC=\<15% blasts in BM and PB; \<30% blasts+promyelocytes in BM \& PB; \<20% basophils in PB; no extra-medullar disease other than spleen \& liver) |
| Secondary | Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Complete Hematologic Response (CHR) | From first dose up to approximately 12 months of follow up after dasatinib treatment (data cut-off date: 18-Jun-2010) | Complete Hematologic Response (CHR) is obtained when all the following criteria are met: WBC ≤ institutional ULN; platelets ≤ 450,000/mm3; ≤20% basophils in peripheral blood; no blasts or promyelocytes in PB cells; \< 5% myelocytes plus metamyelocytes in PB cells; no extra-medullary involvement including no hepatomegaly or splenomegaly. |
| Secondary | Time to Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants | From first dose up to the day criteria were first met for CCyR or PCyR, whichever occurred first. (Up to approximately 12 months of follow up after dasatinib treatment [data cut-off date: 18-Jun-2010]) | Time to MCyR is defined as the time from the first dosing date until day criteria were first met for CCyR or PCyR, whichever occurred first. Major Cytogenetic Response (MCyR) is defined as Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in BM) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in BM). |
| Secondary | Duration of Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants | From first dose until the date of progression or death. (Up to approximately 12 months of follow up after dasatinib treatment [data cut-off date: 18-Jun-2010]) | The duration of time from when the first day all criteria are met for CCyR or PCyR until the date of progression or death. Participants who neither progress nor die will be censored on the date of their last cytogenetic assessment. The duration of MCyR will be estimated via the Kaplan-Meier product-limit method. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in BM) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in BM). |
| Secondary | Progression-free Survival Among CP CML Participants | From first dosing date until the time progressive disease (PD) is first documented. (Up to approximately 12 months of follow up after dasatinib treatment [data cut-off date: 18-Jun-2010]) | Progression-free survival is defined as the time from first dosing date until the time progressive disease (PD) is first documented. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who do not progress nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last. PFS will be analyzed via the Kaplan-Meier product-limit method. Participants were considered as having PD if they: achieved a hematologic response but subsequently no longer meet the criteria consistently on all assessment over a consecutive 2-week period after starting maximum dose; had no decrease from their baseline percent blasts in PB or BM on all assessments over a 4-week period, or had an increase by at least 50% in PB blast count (absolute) over a 2-week period after starting their maximum (individually-tolerated) dose. |
| Secondary | Time to Complete and Major Hematologic Response (CHR and MaHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Participants (Ph+ ALL) | From first dose of Dasatinib until the first day CHR criteria are met (for all confirmed responses). (Up to approximately 12 months of follow up after dasatinib treatment [data cut-off date: 18-Jun-2010]) | The time from first dose of Dasatinib until the first day CHR or MaHR criteria are met (for all confirmed responses). Time to CHR is computed only for participants whose best response is CHR. Major HR (MaHR) includes CHR or no evidence of leukemia (NEL). Major hematologic response: (MaHR) = complete hematologic response (CHR) + no evidence of leukemia (NEL). CHR=white blood cells (WBC) ≤upper limit of normal (ULN); absolute neutrophil count (ANC) ≥1,000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes, \<20% basophils \& \<5% myelocytes+metamyelocytes in peripheral blood (PB); BM blasts ≤5%; no extra-medullary involvement/hepatomegaly/splenomegaly. NEL=CHR except platelets ≥20,000/mm3 \& \<100,000/mm3; ANC \>500/mm3 \& \<1,000/mm3. |
| Secondary | Duration of CHR Among AD CML and Ph+ ALL Participants | From first dose until the date of disease progression (PD) or death. (Up to approximately 12 months of follow up after dasatinib treatment [data cut-off date: 18-Jun-2010]) | Time from the first day all criteria are met for CHR until the date treatment is discontinued due to progressive disease (PD) or death. Participants who neither progress nor die will be censored on the date of their last assessment. CHR=white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥1,000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes, \<20% basophils and \<5% myelocytes+metamyelocytes in peripheral blood (PB); BM blasts ≤5%; no extra-medullary involvement/hepatomegaly/splenomegaly. PD = Hematologic response achieved but subsequently no longer meet the criteria consistently on all assessment over a 2-week period;, and no decrease from their baseline percent blasts in PB or BM on all assessments over a 4-week period or have an increase by at least 50% in PB blast count (absolute) over a 2-week period. |
| Secondary | Duration of MaHR Among AD CML and Ph+ ALL Participants | From first dose until the date of disease progression (PD) or death. (Up to approximately 12 months of follow up after dasatinib treatment [data cut-off date: 18-Jun-2010]) | Time from the first day all criteria are met for CHR or NEL or MaHR until the date of progression or death. Participants who neither progress nor die will be censored on the date of their last assessment. MAHR = CHR or no evidence of leukemia (NEL). CHR=white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥1,000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes, \<20% basophils and \<5% myelocytes+metamyelocytes in peripheral blood (PB); BM blasts ≤5%; no extra-medullary involvement/hepatomegaly/splenomegaly. NEL=CHR except platelets ≥20,000/mm3 and \<100,000/mm3; ANC \>500/mm3 and \<1,000/mm3. Progressive disease (PD) = Hematologic response achieved but subsequently no longer meet the criteria consistently on all assessment over a 2-week period;, and no decrease from their baseline percent blasts in PB or BM on all assessments over a 4-week period or have an increase by at least 50% in PB blast count (absolute) over a 2-week period. |
| Secondary | Progression-free Survival Among AD CML and Ph+ ALL Participants | From first dose until the time progressive disease (PD) is first documented. (Up to approximately 12 months of follow up after dasatinib treatment [data cut-off date: 18-Jun-2010]) | Progression-free survival is defined as the time from first dosing date until the time progressive disease (PD) is first documented. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who do not progress nor die will be censored on the date of their last hematologic or cytogenetic assessment whichever comes last. PFS will be analyzed via the Kaplan-Meier product-limit method. Progressive disease (PD) = Hematologic response achieved but subsequently no longer meet the criteria consistently on all assessment over a 2-week period;, and no decrease from their baseline percent blasts in PB or BM on all assessments over a 4-week period or have an increase by at least 50% in PB blast count (absolute) over a 2-week period. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Major Cytogenetic Response (MCyR) | From first dose up to approximately 12 months of follow up after dasatinib treatment (data cut-off date: 18-Jun-2010) | All treated participants with Chronic Phase Chronic Myeloid Leukemia (CP - CML). Data pre-specified to be collected in the Chronic Phase (CP) CML arm only. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Complete, Major, and Overall Hematologic Response (CHR, MaHR, & OHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Blast Phase CML/Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) | From first dose up to approximately 12 months of follow up after dasatinib treatment (data cut-off date: 18-Jun-2010) | All treated participants with Advanced Disease Chronic Myeloid Leukemia (CML). Data pre-specified to be collected in the Advanced Disease CML - AP and Blast Phase/PH+ ALL arms only. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Complete Hematologic Response (CHR) | From first dose up to approximately 12 months of follow up after dasatinib treatment (data cut-off date: 18-Jun-2010) | All treated participants with Chronic Phase Chronic Myeloid Leukemia (CP - CML). Data pre-specified to be collected in the Chronic Phase (CP) CML arm only. | Percentage of participants | NUMBER |
| SECONDARY | Time to Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants | From first dose up to the day criteria were first met for CCyR or PCyR, whichever occurred first. (Up to approximately 12 months of follow up after dasatinib treatment [data cut-off date: 18-Jun-2010]) | All treated participants with Chronic Phase Chronic Myeloid Leukemia (CP - CML) with MCyR. Data pre-specified to be collected in the Chronic Phase (CP) CML arm only. | Weeks | MEDIAN |
| SECONDARY | Duration of Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants | From first dose until the date of progression or death. (Up to approximately 12 months of follow up after dasatinib treatment [data cut-off date: 18-Jun-2010]) | All treated participants with Chronic Phase Chronic Myeloid Leukemia (CP - CML) with MCyR. Data pre-specified to be collected in the Chronic Phase (CP) CML arm only. | Months | NUMBER |
| SECONDARY | Progression-free Survival Among CP CML Participants | From first dosing date until the time progressive disease (PD) is first documented. (Up to approximately 12 months of follow up after dasatinib treatment [data cut-off date: 18-Jun-2010]) | All treated participants with Chronic Phase Chronic Myeloid Leukemia (CP - CML). Data pre-specified to be collected in the Chronic Phase (CP) CML arm only. | Months | NUMBER |
| SECONDARY | Time to Complete and Major Hematologic Response (CHR and MaHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Participants (Ph+ ALL) | From first dose of Dasatinib until the first day CHR criteria are met (for all confirmed responses). (Up to approximately 12 months of follow up after dasatinib treatment [data cut-off date: 18-Jun-2010]) | All treated participants with Advanced Disease Chronic Myeloid Leukemia (CML) with CHR or MaHR. Data pre-specified to be collected in the Advanced Disease CML - AP and Blast Phase/PH+ ALL arms only. | Weeks | MEDIAN |
| SECONDARY | Duration of CHR Among AD CML and Ph+ ALL Participants | From first dose until the date of disease progression (PD) or death. (Up to approximately 12 months of follow up after dasatinib treatment [data cut-off date: 18-Jun-2010]) | All treated participants with Advanced Disease Chronic Myeloid Leukemia (CML) with CHR. Data pre-specified to be collected in the Advanced Disease CML - AP and Blast Phase/PH+ ALL arms only. | Months | NUMBER |
| SECONDARY | Duration of MaHR Among AD CML and Ph+ ALL Participants | From first dose until the date of disease progression (PD) or death. (Up to approximately 12 months of follow up after dasatinib treatment [data cut-off date: 18-Jun-2010]) | All treated participants with Advanced Disease Chronic Myeloid Leukemia (CML) with CHR or NEL or MiHR. Data pre-specified to be collected in the Advanced Disease CML - AP and Blast Phase/PH+ ALL arms only. | Months | NUMBER |
| SECONDARY | Progression-free Survival Among AD CML and Ph+ ALL Participants | From first dose until the time progressive disease (PD) is first documented. (Up to approximately 12 months of follow up after dasatinib treatment [data cut-off date: 18-Jun-2010]) | All treated participants with Advanced Disease Chronic Myeloid Leukemia (CML). Data pre-specified to be collected in the Advanced Disease CML - AP and Blast Phase/PH+ ALL arms only. | Months | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group141
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Major Cytogenetic Response (MCyR) | Chronic Phase (CP) CML | 50.8 | 95% Confidence Interval 37.5 to 64.1 | Percentage of participants | |
Percentage of Participants With Complete, Major, and Overall Hematologic Response (CHR, MaHR, & OHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Blast Phase CML/Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) | Advanced Disease CML - Accelerated Phase (AP) | CHR | 52.0 | 95% Confidence Interval 31.3 to 72.2 | Percentage of participants |
Percentage of Participants With Complete, Major, and Overall Hematologic Response (CHR, MaHR, & OHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Blast Phase CML/Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) | Advanced Disease CML - Blast Phase/PH+ ALL | CHR | 16.2 | 95% Confidence Interval 6.2 to 32.0 | Percentage of participants |
Percentage of Participants With Complete, Major, and Overall Hematologic Response (CHR, MaHR, & OHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Blast Phase CML/Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) | Advanced Disease CML - Accelerated Phase (AP) | MaHR | 84.0 | 95% Confidence Interval 63.9 to 95.5 | Percentage of participants |
Percentage of Participants With Complete, Major, and Overall Hematologic Response (CHR, MaHR, & OHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Blast Phase CML/Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) | Advanced Disease CML - Blast Phase/PH+ ALL | MaHR | 29.7 | 95% Confidence Interval 15.9 to 47.0 | Percentage of participants |
Percentage of Participants With Complete, Major, and Overall Hematologic Response (CHR, MaHR, & OHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Blast Phase CML/Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) | Advanced Disease CML - Accelerated Phase (AP) | OHR | 92.0 | 95% Confidence Interval 74.0 to 99.0 | Percentage of participants |
Percentage of Participants With Complete, Major, and Overall Hematologic Response (CHR, MaHR, & OHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Blast Phase CML/Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) | Advanced Disease CML - Blast Phase/PH+ ALL | OHR | 35.1 | 95% Confidence Interval 20.2 to 52.5 | Percentage of participants |
| Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Complete Hematologic Response (CHR) | Chronic Phase (CP) CML | 91.5 | 95% Confidence Interval 81.3 to 97.2 | Percentage of participants | |
| Time to Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants | Chronic Phase (CP) CML | 12.1 | Full Range 4.3 to 48.0 | Weeks | |
| Duration of Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants | Chronic Phase (CP) CML | NA | 95% Confidence Interval NA to NA | Months |
1 to 10 of 141Source ClinicalTrials.gov
See all 141 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Advanced Disease CML - Accelerated Phase (AP) | 25 | |
| Overall Study | STARTED | Advanced Disease CML - Blast Phase/PH+ ALL | 37 | |
| Overall Study | STARTED | Chronic Phase (CP) CML | 59 | |
| Overall Study | COMPLETED | Advanced Disease CML - Accelerated Phase (AP) | 4 | |
| Overall Study | COMPLETED | Advanced Disease CML - Blast Phase/PH+ ALL | 0 | |
| Overall Study | COMPLETED | Chronic Phase (CP) CML | 27 | |
| Overall Study | NOT COMPLETED | Advanced Disease CML - Accelerated Phase (AP) | 21 | |
| Overall Study | NOT COMPLETED | Advanced Disease CML - Blast Phase/PH+ ALL | 37 | |
| Overall Study | NOT COMPLETED | Chronic Phase (CP) CML | 32 |
Source ClinicalTrials.gov
Adverse events312
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Advanced Disease CML - Accelerated Phase (AP) | 3 | 25 | |
| other | Anaemia | Blood and lymphatic system disorders | Advanced Disease CML - Blast Phase/PH+ ALL | 3 | 37 | |
| other | Anaemia | Blood and lymphatic system disorders | Chronic Phase (CP) CML | 10 | 59 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Advanced Disease CML - Accelerated Phase (AP) | 1 | 25 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Advanced Disease CML - Blast Phase/PH+ ALL | 2 | 37 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Chronic Phase (CP) CML | 0 | 59 | |
| other | Leukopenia | Blood and lymphatic system disorders | Advanced Disease CML - Accelerated Phase (AP) | 4 | 25 | |
| other | Leukopenia | Blood and lymphatic system disorders | Advanced Disease CML - Blast Phase/PH+ ALL | 1 | 37 | |
| other | Leukopenia | Blood and lymphatic system disorders | Chronic Phase (CP) CML | 1 | 59 | |
| other | Neutropenia | Blood and lymphatic system disorders | Advanced Disease CML - Accelerated Phase (AP) | 7 | 25 |
1 to 10 of 312Source ClinicalTrials.gov
See all 312 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Advanced Disease CML - Accelerated Phase (AP) | 5 | 25 |
| Total, all-cause mortality | Advanced Disease CML - Blast Phase/PH+ ALL | 16 | 37 |
| Total, all-cause mortality | Chronic Phase (CP) CML | 5 | 59 |
| Total, other adverse events | Advanced Disease CML - Accelerated Phase (AP) | 24 | 25 |
| Total, other adverse events | Advanced Disease CML - Blast Phase/PH+ ALL | 30 | 37 |
| Total, other adverse events | Chronic Phase (CP) CML | 50 | 59 |
| Total, serious adverse events | Advanced Disease CML - Accelerated Phase (AP) | 13 | 25 |
| Total, serious adverse events | Advanced Disease CML - Blast Phase/PH+ ALL | 24 | 37 |
| Total, serious adverse events | Chronic Phase (CP) CML | 18 | 59 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT00529763/results?page=2