Trial Outcomes & Findings for An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment (NCT NCT00980018)
NCT ID: NCT00980018
Last Updated: 2021-07-01
Results Overview
A patient was considered improved if 50% or more of the chronic imatinib-related chronic low grade nonhematologic AEs showed improvement (a decrease in CTCAE \[Common Terminology Criteria for Adverse Events\] grade or complete resolution).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
52 participants
Primary outcome timeframe
End of Cycles 1, 2, and 3
Results posted on
2021-07-01
Participant Flow
The study was conducted at 15 centers in US and 4 centers in Canada from 10-December-2009 (first patient first visit) to 27-December-2012 (last patient last visit).
A total of 68 patients were screened out of which 52 enrolled and 40 completed the full duration of treatment.
Participant milestones
| Measure |
Nilotinib
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
|
|---|---|
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Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Nilotinib
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
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|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Patient withdrew consent
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment
Baseline characteristics by cohort
| Measure |
Nilotinib
n=52 Participants
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
|
|---|---|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 10.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of Cycles 1, 2, and 3Population: Full Analysis Set (FAS): All participants who received at least one dose of study drug.
A patient was considered improved if 50% or more of the chronic imatinib-related chronic low grade nonhematologic AEs showed improvement (a decrease in CTCAE \[Common Terminology Criteria for Adverse Events\] grade or complete resolution).
Outcome measures
| Measure |
Nilotinib
n=52 Participants
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
|
|---|---|
|
Percentage of Participants With Improvement in Imatinib Related Chronic Low Grade Non Hematologic Adverse Event (AE) After Switch to Treatment With Nilotinib at End of Cycle 3
End of Cycle 1
|
37 Participants
|
|
Percentage of Participants With Improvement in Imatinib Related Chronic Low Grade Non Hematologic Adverse Event (AE) After Switch to Treatment With Nilotinib at End of Cycle 3
End of Cycle 2
|
43 Participants
|
|
Percentage of Participants With Improvement in Imatinib Related Chronic Low Grade Non Hematologic Adverse Event (AE) After Switch to Treatment With Nilotinib at End of Cycle 3
End of Cycle 3
|
44 Participants
|
SECONDARY outcome
Timeframe: Cycles 1, 2, 6, 9, and 12Population: FAS : All participants who received at least one dose of study drug.
Time to complete cytogenetic response is defined as time from baseline to first time of CCyR as documented by bone marrow cytogenetics. Cytogenetic response was assessed as applicable by bone marrow cytogenetics 6, 12, and 18 months after starting imatinib therapy. Assess CCyR by bone marrow cytogenics
Outcome measures
| Measure |
Nilotinib
n=7 Participants
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
|
|---|---|
|
Percentage of Participants Achieving Complete Cytogenetic Response (CCyR) After Switching to Nilotinib for Participants Not Reporting CCyR at Baseline
Cycle 2
|
3 Participants
|
|
Percentage of Participants Achieving Complete Cytogenetic Response (CCyR) After Switching to Nilotinib for Participants Not Reporting CCyR at Baseline
Cycle 3
|
0 Participants
|
|
Percentage of Participants Achieving Complete Cytogenetic Response (CCyR) After Switching to Nilotinib for Participants Not Reporting CCyR at Baseline
Cycle 6
|
2 Participants
|
|
Percentage of Participants Achieving Complete Cytogenetic Response (CCyR) After Switching to Nilotinib for Participants Not Reporting CCyR at Baseline
Cycle 12
|
0 Participants
|
|
Percentage of Participants Achieving Complete Cytogenetic Response (CCyR) After Switching to Nilotinib for Participants Not Reporting CCyR at Baseline
Cycle 1
|
2 Participants
|
|
Percentage of Participants Achieving Complete Cytogenetic Response (CCyR) After Switching to Nilotinib for Participants Not Reporting CCyR at Baseline
Cycle 9
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycles 1,2,3,6,9,12Population: FAS : All participants who received at least one dose of study drug.
Major Molecular Response (MMR) value at Molecular MD is designated a percentage, which is equivalent to a 3-log reduction from a standardized baseline value from the International Randomized Interferon versus STI571 (IRIS) study or 0.1% per International Scale (IS). Time to MMR is defined as time from baseline to first time of MMR as documented by RQ-PCR
Outcome measures
| Measure |
Nilotinib
n=18 Participants
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
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|---|---|
|
Percentage of Participants Achieving Major Molecular Response (MMR) After the Switch in the Therapy for Participants Not Reporting MMR at Baseline
Cycle 1
|
2 Participants
|
|
Percentage of Participants Achieving Major Molecular Response (MMR) After the Switch in the Therapy for Participants Not Reporting MMR at Baseline
Cycle 3
|
3 Participants
|
|
Percentage of Participants Achieving Major Molecular Response (MMR) After the Switch in the Therapy for Participants Not Reporting MMR at Baseline
Cycle 6
|
2 Participants
|
|
Percentage of Participants Achieving Major Molecular Response (MMR) After the Switch in the Therapy for Participants Not Reporting MMR at Baseline
Cycle 12
|
0 Participants
|
|
Percentage of Participants Achieving Major Molecular Response (MMR) After the Switch in the Therapy for Participants Not Reporting MMR at Baseline
Cycle 2
|
6 Participants
|
|
Percentage of Participants Achieving Major Molecular Response (MMR) After the Switch in the Therapy for Participants Not Reporting MMR at Baseline
Cycle 9
|
2 Participants
|
SECONDARY outcome
Timeframe: Cycles 1,2,3,6,9, and 12Population: FAS: All participants who received at least one dose of study drug.
Levels of BCR-ABL transcripts were determined by quantitative RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR-ABL transcripts levels from the standardized baseline value will be calculated for each sample from the reported percent ratio of BCR-ABL transcripts versus control gene transcripts converted to a reference standard.
Outcome measures
| Measure |
Nilotinib
n=52 Participants
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
|
|---|---|
|
Log Change in BCR-Abl Transcript Level From Baseline After the Switch Therapy
Cycle 1
|
-0.177 log change from Baseline
Standard Deviation 0.3665
|
|
Log Change in BCR-Abl Transcript Level From Baseline After the Switch Therapy
Cycle 2
|
-0.407 log change from Baseline
Standard Deviation 0.5748
|
|
Log Change in BCR-Abl Transcript Level From Baseline After the Switch Therapy
Cycle 3
|
-0.540 log change from Baseline
Standard Deviation 0.6960
|
|
Log Change in BCR-Abl Transcript Level From Baseline After the Switch Therapy
Cycle 9
|
-0.844 log change from Baseline
Standard Deviation 0.9130
|
|
Log Change in BCR-Abl Transcript Level From Baseline After the Switch Therapy
Cycle 12
|
-0.902 log change from Baseline
Standard Deviation 0.9913
|
|
Log Change in BCR-Abl Transcript Level From Baseline After the Switch Therapy
Cycle 6
|
-0.718 log change from Baseline
Standard Deviation 0.9313
|
SECONDARY outcome
Timeframe: 18 months of follow up from the first documented responsePopulation: FAS: All participants who received at least one dose of study drug.
Duration of Complete Cytogenetic Response is defined as the time from first CCyR to first loss of CCyR as documented by bone marrow cytogenetics, or by FISH assay, whichever is earlier. The duration of CCyR begins on the day of enrollment for patients reporting CCyR at baseline.
Outcome measures
| Measure |
Nilotinib
n=52 Participants
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
|
|---|---|
|
Duration of Complete Cytogenetic Response
Participants with CCyR at baseline
|
319.7 days
Standard Deviation 143.03
|
|
Duration of Complete Cytogenetic Response
Participants achieving CCyR on study
|
266.3 days
Standard Deviation 86.73
|
SECONDARY outcome
Timeframe: Cycle 12Population: FAS: All participants who received at least one dose of study drug.
For time to CCyR, an event is defined as achievement of CCyR documented by bone marrow cytogenetics.
Outcome measures
| Measure |
Nilotinib
n=7 Participants
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
|
|---|---|
|
Time to Complete Cytogenetic Response in Participants Not Reporting at Baseline
|
1.9 months
Interval 0.9 to 5.7
|
SECONDARY outcome
Timeframe: 18 months of follow up from the first documented responsePopulation: FAS : All participants who received at least one dose of study drug.
Duration of Major Molecular Response is defined as the time from first MMR to first loss of MMR as documented by RQ-PCR. The duration of MMR begins on the day of enrollment for patients reporting MMR at baseline.
Outcome measures
| Measure |
Nilotinib
n=49 Participants
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
|
|---|---|
|
Duration of Major Molecular Response
Participants with MMR at baseline
|
277.6 days
Standard Deviation 166.88
|
|
Duration of Major Molecular Response
Participants achieving MMR on study
|
208.3 days
Standard Deviation 123.61
|
SECONDARY outcome
Timeframe: Cycles 1,2,3,6,9,12Population: FAS : All participants who received at least one dose of study drug.
For time to MMR, an event is defined as achievement of MMR documented by RQ-PCR. Patients with MMR at the Screening RQ-PCR assay are counted as having time to MMR equal to 0.
Outcome measures
| Measure |
Nilotinib
n=18 Participants
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
|
|---|---|
|
Time to Major Molecular Response (MMR) in Participants With MMR Absent at Baseline
|
2.8 months
Interval 1.8 to 5.8
|
SECONDARY outcome
Timeframe: 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these eventsPopulation: FAS: All participants who received at least one dose of study drug.
Time to optimal improvement is defined as the time when the sum of the total CTCAE toxicity grades for a patient's chronic low-grade imatinib-related adverse events reaches its minimum value.
Outcome measures
| Measure |
Nilotinib
n=52 Participants
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
|
|---|---|
|
Time to Optimal Imatinib-related Adverse Event Improvement
|
1.9 months
Interval 1.0 to 2.1
|
Adverse Events
Nilotinib
Serious events: 9 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nilotinib
n=52 participants at risk
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Coronary artery disease
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
Pain
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Bronchitis
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Gastroenteritis
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Vulval cellulitis
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Wound infection bacterial
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Wound infection staphylococcal
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Facial palsy
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Reproductive system and breast disorders
Ovarian torsion
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Arteriosclerosis
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Hypotension
|
1.9%
1/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
Other adverse events
| Measure |
Nilotinib
n=52 participants at risk
Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).
|
|---|---|
|
Eye disorders
Dry eye
|
7.7%
4/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
8/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
26.9%
14/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
8/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
4/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.5%
6/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
21.2%
11/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
Chest pain
|
5.8%
3/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
Chills
|
9.6%
5/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
Fatigue
|
32.7%
17/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
General disorders
Pyrexia
|
5.8%
3/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Sinusitis
|
5.8%
3/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.5%
6/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Lipase increased
|
5.8%
3/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Investigations
Weight decreased
|
9.6%
5/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Anorexia
|
13.5%
7/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.8%
3/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.7%
4/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.8%
3/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.8%
3/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.1%
12/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.8%
3/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
15.4%
8/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
4/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.6%
5/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Dizziness
|
7.7%
4/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Headache
|
32.7%
17/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Hypoaesthesia
|
5.8%
3/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Depression
|
5.8%
3/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Insomnia
|
11.5%
6/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.6%
5/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.8%
3/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.3%
9/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.5%
7/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.5%
7/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
9.6%
5/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.1%
12/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
32.7%
17/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
7.7%
4/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Hot flush
|
9.6%
5/52 • 18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place