Trial Outcomes & Findings for A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation (NCT NCT01744665)
NCT ID: NCT01744665
Last Updated: 2020-03-10
Results Overview
Percentage of particpants without confirmed loss of MMR within 6 months following nilotinib TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, in the first 6 months after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase. Molecular relapse is defined as having a confirmed BCR-ABL ratio above MMR (2 consecutive BCR-ABL levels \>0.1% IS taken approximately 4 weeks apart).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
6 months after stopping nilotinib therapy
Results posted on
2020-03-10
Participant Flow
Participant milestones
| Measure |
Nilotinib
All patients enrolled in trial
|
|---|---|
|
Monitoring Phase
STARTED
|
59
|
|
Monitoring Phase
COMPLETED
|
41
|
|
Monitoring Phase
NOT COMPLETED
|
18
|
|
Consolidation Phase
STARTED
|
41
|
|
Consolidation Phase
COMPLETED
|
22
|
|
Consolidation Phase
NOT COMPLETED
|
19
|
|
Treatment Free Remission Phase
STARTED
|
32
|
|
Treatment Free Remission Phase
COMPLETED
|
32
|
|
Treatment Free Remission Phase
NOT COMPLETED
|
0
|
|
Re-initiation Phase
STARTED
|
17
|
|
Re-initiation Phase
COMPLETED
|
4
|
|
Re-initiation Phase
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Nilotinib
All patients enrolled in trial
|
|---|---|
|
Monitoring Phase
Adverse Event
|
4
|
|
Monitoring Phase
Abnormal laboratory value(s)
|
1
|
|
Monitoring Phase
Unsatisfactory therapeutic effect
|
7
|
|
Monitoring Phase
Withdrawal by Subject
|
5
|
|
Monitoring Phase
Did not achieve MR4.5
|
1
|
|
Consolidation Phase
Adverse Event
|
2
|
|
Consolidation Phase
Unsatisfactory therapeutic effect
|
4
|
|
Consolidation Phase
Withdrawal by Subject
|
4
|
|
Consolidation Phase
Administrative problems
|
9
|
|
Re-initiation Phase
Administrative problems
|
10
|
|
Re-initiation Phase
Adverse Event
|
1
|
|
Re-initiation Phase
No longer required treatment
|
1
|
|
Re-initiation Phase
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation
Baseline characteristics by cohort
| Measure |
Overall
n=32 Participants
Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.
|
|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 12.44 • n=93 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
25 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 months after stopping nilotinib therapyPercentage of particpants without confirmed loss of MMR within 6 months following nilotinib TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, in the first 6 months after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase. Molecular relapse is defined as having a confirmed BCR-ABL ratio above MMR (2 consecutive BCR-ABL levels \>0.1% IS taken approximately 4 weeks apart).
Outcome measures
| Measure |
Treatment Free Remission
n=32 Participants
Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.
|
Some Problems
Some problems
|
Extreme Problems
Extreme problems
|
|---|---|---|---|
|
Percentage of Participants Without Molecular Relapse Within 6 Months After Starting the TFR Phase
Number of participants
|
12 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 yearsRelapse-free survival after the start of the TFR phase was summarized using the product-limit (Kaplan-Meier) estimates. The median for the relapse free survival and its 95% confidence intervals were provided. This analysis was performed on the FAS. Patients who dropped out without relapse were treated as censored observations.
Outcome measures
| Measure |
Treatment Free Remission
n=32 Participants
Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.
|
Some Problems
Some problems
|
Extreme Problems
Extreme problems
|
|---|---|---|---|
|
Relapse Free Survival is Defined as Time From the Date of Nilotinib Treatment Discontinuation to the First Documented Molecular Relapse (Confirmed Loss of MR4.5).
|
21.4 weeks
Interval 17.1 to
The upper limit CI was not estimable
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 and 24 months after starting the TFRThe percentage of participants without confirmed loss of MRR at 12 and 24 months is calculated by dividing the number of patients with no documented confirmed loss of MR4 at 12 and 24 months after starting the nilotinib TFR phase by the number of patients who entered nilotinib TFR phase.
Outcome measures
| Measure |
Treatment Free Remission
n=32 Participants
Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.
|
Some Problems
Some problems
|
Extreme Problems
Extreme problems
|
|---|---|---|---|
|
Percentage of Participants Without Molecular Relapse Within 12 and 24 Months After Starting the Treatment -Free Remission (TFR) Phase
Month 12 · Number of participants
|
8 Participants
|
—
|
—
|
|
Percentage of Participants Without Molecular Relapse Within 12 and 24 Months After Starting the Treatment -Free Remission (TFR) Phase
Month 24 · Number of participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Restart of nilotinib up to month 6, 12 and 24The percentage of participants who regained MR4.5 after restarting nilotinib will be calculated as the number of patients who achieved MR4.5 after having lost MR4 divided by the number of patients who lost MR4.
Outcome measures
| Measure |
Treatment Free Remission
n=17 Participants
Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.
|
Some Problems
Some problems
|
Extreme Problems
Extreme problems
|
|---|---|---|---|
|
Percentage of Participants Who Regained MR4.5 After Restarting Nilotinib Due to Molecular Relapse
Month 12 · Number of participants
|
17 Participants
|
—
|
—
|
|
Percentage of Participants Who Regained MR4.5 After Restarting Nilotinib Due to Molecular Relapse
Month 6 · Number of participants
|
7 Participants
|
—
|
—
|
|
Percentage of Participants Who Regained MR4.5 After Restarting Nilotinib Due to Molecular Relapse
Month 24 · Number of participants
|
17 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to approximately 5 yearsProgression to AP/BC and death where the "failure" event is the earliest occurrence of the following event: progression to AP/BC date.
Outcome measures
| Measure |
Treatment Free Remission
n=32 Participants
Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.
|
Some Problems
Some problems
|
Extreme Problems
Extreme problems
|
|---|---|---|---|
|
Number of Participants Who Progressed to Accelerated Phase/Blastic Crisis (AP/BC) or Died From From Any Cause.
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to approximately 5 yearsOS was defined as the time from the date of cessation of nilotinib therapy to the date of death from any cause.
Outcome measures
| Measure |
Treatment Free Remission
n=32 Participants
Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.
|
Some Problems
Some problems
|
Extreme Problems
Extreme problems
|
|---|---|---|---|
|
Overall Survival (OS)
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to time to when MR4.5 is confirmed, up to 24 months, and from end of Consolidation Phase to 6 and 12 months into the TFR PhasePopulation: Number of participants who completed questionnaire varied across visits
The M.D. Anderson Symptom Inventory for CML patients (MDASI-CML) was used to assess the nature and impact of symptom burden on life. It consisted of 20 validated symptom items and 6 validated interference items. Each item was assessed on an 11 point scale with responses from 0-10, 0=not present and 10=as bad as you can imagine. Symptom score (SS) was calculated when a patient scored at least 8 items of the symptom items using the formula: (sum of scores for the items answered) / number of items answered. If a subject responded to \< 8 symptom items, the score was considered missing. Interference score (IS) was calculated when a patient scored at least 4 items using the formula: (sum of scores for the items answered)/number of items answered. If a subject responded to \< 4 interference items, the score was considered missing. The total symptom score was 0-200 and total interference score was 0-60. Mean change from baseline was summarized at all post-baseline time points
Outcome measures
| Measure |
Treatment Free Remission
n=59 Participants
Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.
|
Some Problems
Some problems
|
Extreme Problems
Extreme problems
|
|---|---|---|---|
|
Change in Symptom-burden Scores by the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Assessment
SS Baseline (observed value), n=40
|
0.125 scores on a scale
Standard Deviation 0.1314
|
—
|
—
|
|
Change in Symptom-burden Scores by the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Assessment
SS Consolidation Ph - M 3 (change from BL) n=26
|
0.012 scores on a scale
Standard Deviation 0.1362
|
—
|
—
|
|
Change in Symptom-burden Scores by the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Assessment
SS Consolidation Ph - M 12 (change from BL) n=30
|
0.021 scores on a scale
Standard Deviation 0.1140
|
—
|
—
|
|
Change in Symptom-burden Scores by the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Assessment
SS Consolidation Ph - M 24 (change from BL) n=26
|
0.026 scores on a scale
Standard Deviation 0.1402
|
—
|
—
|
|
Change in Symptom-burden Scores by the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Assessment
SS TFR Baseline (observed value) n=32
|
0.160 scores on a scale
Standard Deviation 0.1496
|
—
|
—
|
|
Change in Symptom-burden Scores by the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Assessment
SS TFR - Month 6 (change from BL) n=10
|
-0.005 scores on a scale
Standard Deviation 0.1773
|
—
|
—
|
|
Change in Symptom-burden Scores by the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Assessment
SS TFR - Month 12 (change from BL) n=5
|
-0.032 scores on a scale
Standard Deviation 0.1034
|
—
|
—
|
|
Change in Symptom-burden Scores by the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Assessment
IS Baseline (observed value), n=40
|
0.123 scores on a scale
Standard Deviation 0.2156
|
—
|
—
|
|
Change in Symptom-burden Scores by the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Assessment
IS Consolidation Ph - M 3 (change from BL) n=25
|
0.008 scores on a scale
Standard Deviation 0.1911
|
—
|
—
|
|
Change in Symptom-burden Scores by the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Assessment
IS Consolidation Ph - M 12 (change from BL) n=30
|
-0.005 scores on a scale
Standard Deviation 0.1983
|
—
|
—
|
|
Change in Symptom-burden Scores by the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Assessment
IS Consolidation Ph - M 24 (change from BL) n=26
|
0.015 scores on a scale
Standard Deviation 0.1942
|
—
|
—
|
|
Change in Symptom-burden Scores by the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Assessment
IS TFR Baseline (observed value) n=32
|
0.141 scores on a scale
Standard Deviation 0.2067
|
—
|
—
|
|
Change in Symptom-burden Scores by the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Assessment
IS TFR - Month 6 (change from BL) n=10
|
-0.015 scores on a scale
Standard Deviation 0.1780
|
—
|
—
|
|
Change in Symptom-burden Scores by the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Assessment
IS TFR - Month 12 (change from BL) n=5
|
-0.037 scores on a scale
Standard Deviation 0.1880
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to time to when MR4.5, up to 24 months, is confirmed and from end of Consolidation Phase to 6 and 12 months into the TFR PhasePopulation: Number of participants who completed questionnaire varied across visits
The EQ-5D-3L questionnaire comprises 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and visual analog has a scale 0 to 100 (0=worst imaginable health state, 100=best imaginable health state).
Outcome measures
| Measure |
Treatment Free Remission
n=36 Participants
Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.
|
Some Problems
Some problems
|
Extreme Problems
Extreme problems
|
|---|---|---|---|
|
Change in Health Utility Assessed by EuroQol Group-5D-3L (EQ-5D-3L) Visual Analogue - Safety Set
Baseline (observed value)
|
83.250 scores on scale
Interval 4.5 to 100.0
|
—
|
—
|
|
Change in Health Utility Assessed by EuroQol Group-5D-3L (EQ-5D-3L) Visual Analogue - Safety Set
Consolidation Ph - M 3 (change from BL)
|
2.000 scores on scale
Interval -50.0 to 87.0
|
—
|
—
|
|
Change in Health Utility Assessed by EuroQol Group-5D-3L (EQ-5D-3L) Visual Analogue - Safety Set
Consolidation Ph - M 12 (change from BL)
|
3.250 scores on scale
Interval -75.0 to 82.0
|
—
|
—
|
|
Change in Health Utility Assessed by EuroQol Group-5D-3L (EQ-5D-3L) Visual Analogue - Safety Set
Consolidation Ph - M 24 (change from BL)
|
1.350 scores on scale
Interval -30.0 to 85.5
|
—
|
—
|
|
Change in Health Utility Assessed by EuroQol Group-5D-3L (EQ-5D-3L) Visual Analogue - Safety Set
TFR Baseline (observed value)
|
80.00 scores on scale
Interval 9.35 to 100.0
|
—
|
—
|
|
Change in Health Utility Assessed by EuroQol Group-5D-3L (EQ-5D-3L) Visual Analogue - Safety Set
TFR - Month 6 (change from BL)
|
10.00 scores on scale
Interval -30.0 to 89.65
|
—
|
—
|
|
Change in Health Utility Assessed by EuroQol Group-5D-3L (EQ-5D-3L) Visual Analogue - Safety Set
TFR - Month 12 (change from BL)
|
0.000 scores on scale
Interval -20.0 to 35.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to time to when MR4.5 is confirmed and from end of Consolidation Phase to 6 and 12 months into the TFR PhasePopulation: Number of participants who completed questionnaire varied across visits
The SF-8 questionnaire consisted of 8 items (general health, physical functioning, role physical, bodily pain, vitality, social functioning, role-emotional and mental health) and was used to assess the impact of nilotinib treatment discontinuation on the quality of life. Each item had a 1 to 5 or 1 to 6 point response range and the higher number in the raw scores indicated poorer quality of life. The physical and mental component summary measures were calculated using a norm-based scoring method given in the instrument guidelines. These norm-based scores were summarized at baseline and mean change from baseline for post-baseline time points. The norm-based scores (based on the US population) had a mean of 50 and standard deviation of 10. Higher norm-based summary scores indicated better health
Outcome measures
| Measure |
Treatment Free Remission
n=41 Participants
Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.
|
Some Problems
Some problems
|
Extreme Problems
Extreme problems
|
|---|---|---|---|
|
Change in Observed Scores for Patient Quality of Life Assessed by SF-8 - Safety Set
Baseline
|
50.508 scores on a scale
Standard Deviation 8.4313
|
—
|
—
|
|
Change in Observed Scores for Patient Quality of Life Assessed by SF-8 - Safety Set
Consolidation Ph - M 3
|
50.720 scores on a scale
Standard Deviation 7.6047
|
—
|
—
|
|
Change in Observed Scores for Patient Quality of Life Assessed by SF-8 - Safety Set
Consolidation Ph - M 12
|
49.020 scores on a scale
Standard Deviation 10.1851
|
—
|
—
|
|
Change in Observed Scores for Patient Quality of Life Assessed by SF-8 - Safety Set
Consolidation Ph - M 24
|
47.648 scores on a scale
Standard Deviation 8.7416
|
—
|
—
|
|
Change in Observed Scores for Patient Quality of Life Assessed by SF-8 - Safety Set
TFR Baseline
|
48.382 scores on a scale
Standard Deviation 8.6503
|
—
|
—
|
|
Change in Observed Scores for Patient Quality of Life Assessed by SF-8 - Safety Set
TFR - Month 6
|
46.605 scores on a scale
Standard Deviation 9.5042
|
—
|
—
|
|
Change in Observed Scores for Patient Quality of Life Assessed by SF-8 - Safety Set
TFR - Month 12
|
46.006 scores on a scale
Standard Deviation 8.6997
|
—
|
—
|
SECONDARY outcome
Timeframe: At month 3 in Consolidation PhasePopulation: all completers did not complete all categories of questionaire
The EuroQol Five Dimensional Three-level (EQ-5D-3L) questionnaire comprises 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 levels (no problems, some problems and extreme problems). The percentages of patients at each level of the five items of the EQ-5D-3L will be summarized at each time point
Outcome measures
| Measure |
Treatment Free Remission
n=26 Participants
Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.
|
Some Problems
n=26 Participants
Some problems
|
Extreme Problems
n=26 Participants
Extreme problems
|
|---|---|---|---|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 3 in Consolidation Phase - Safety Set
Mobility · Number of participants
|
22 Participants
|
4 Participants
|
0 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 3 in Consolidation Phase - Safety Set
Self-Care · Number of participants
|
25 Participants
|
1 Participants
|
0 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 3 in Consolidation Phase - Safety Set
Usual Activities · Number of participants
|
21 Participants
|
5 Participants
|
0 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 3 in Consolidation Phase - Safety Set
Pain/Discomfort · Number of participants
|
12 Participants
|
13 Participants
|
0 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 3 in Consolidation Phase - Safety Set
Anxiety / Depresssion · Number of participants
|
20 Participants
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 12 in Consolidation PhasePopulation: all completers did not complete all categories of questionaire
The EuroQol Five Dimensional Three-level (EQ-5D-3L) questionnaire comprises 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 levels (no problems, some problems and extreme problems). The percentages of patients at each level of the five items of the EQ-5D-3L will be summarized at each time point
Outcome measures
| Measure |
Treatment Free Remission
n=31 Participants
Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.
|
Some Problems
n=31 Participants
Some problems
|
Extreme Problems
n=31 Participants
Extreme problems
|
|---|---|---|---|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 12 in Consolidation Phase - Safety Set
Mobility · Number of participants
|
23 Participants
|
8 Participants
|
0 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 12 in Consolidation Phase - Safety Set
Self-Care · Number of participants
|
31 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 12 in Consolidation Phase - Safety Set
Usual Activities · Number of participants
|
23 Participants
|
7 Participants
|
1 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 12 in Consolidation Phase - Safety Set
Pain/Discomfort · Number of participants
|
18 Participants
|
11 Participants
|
1 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 12 in Consolidation Phase - Safety Set
Anxiety / Depresssion · Number of participants
|
21 Participants
|
10 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 24 in Consolidation PhasePopulation: all completers did not complete all categories of questionaire
The EuroQol Five Dimensional Three-level (EQ-5D-3L) questionnaire comprises 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 levels (no problems, some problems and extreme problems). The percentages of patients at each level of the five items of the EQ-5D-3L will be summarized at each time point
Outcome measures
| Measure |
Treatment Free Remission
n=28 Participants
Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.
|
Some Problems
n=28 Participants
Some problems
|
Extreme Problems
n=28 Participants
Extreme problems
|
|---|---|---|---|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 24 in Consolidation Phase - Safety Set
Mobility · Number of participants
|
19 Participants
|
8 Participants
|
0 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 24 in Consolidation Phase - Safety Set
Self-Care · Number of participants
|
28 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 24 in Consolidation Phase - Safety Set
Usual Activities · Number of participants
|
23 Participants
|
4 Participants
|
0 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 24 in Consolidation Phase - Safety Set
Pain/Discomfort · Number of participants
|
17 Participants
|
9 Participants
|
2 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 24 in Consolidation Phase - Safety Set
Anxiety / Depresssion · Number of participants
|
19 Participants
|
8 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 6 in in Treatment Free Remission PhasePopulation: all completers did not complete all categories of questionaire
The EuroQol Five Dimensional Three-level questionnaire (EQ-5D-3L) comprises 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 levels (no problems, some problems and extreme problems). The percentages of patients at each level of the five items of the EQ-5D-3L will be summarized at each time point
Outcome measures
| Measure |
Treatment Free Remission
n=10 Participants
Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.
|
Some Problems
n=10 Participants
Some problems
|
Extreme Problems
n=10 Participants
Extreme problems
|
|---|---|---|---|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 6 in Treatment Free Remission Phase - Safety Set
Mobility · Number of participants
|
7 Participants
|
3 Participants
|
0 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 6 in Treatment Free Remission Phase - Safety Set
Self-Care · Number of participants
|
10 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 6 in Treatment Free Remission Phase - Safety Set
Usual Activities · Number of participants
|
10 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 6 in Treatment Free Remission Phase - Safety Set
Pain/Discomfort · Number of participants
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 6 in Treatment Free Remission Phase - Safety Set
Anxiety / Depresssion · Number of participants
|
8 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 12 in in Treatment Free Remission PhasePopulation: all completers did not complete all categories of questionaire
The EuroQol Five Dimensional Three-level questionnaire (EQ-5D-3L) comprises 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 levels (no problems, some problems and extreme problems). The percentages of patients at each level of the five items of the EQ-5D-3L will be summarized at each time point
Outcome measures
| Measure |
Treatment Free Remission
n=5 Participants
Patients entered a monitoring phase for 2 years and received 300 mg nilotinib mg bid. Patients who achieved MR4.5 entered a Consolidation Phase and were treated with nilotinib for 2 years. If MR4.5 was sustained during the Consolidation phase, patients were eligible to stop taking niltoinib during the treatment-free remission (TFR) phase.
|
Some Problems
n=5 Participants
Some problems
|
Extreme Problems
n=5 Participants
Extreme problems
|
|---|---|---|---|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 12 in Treatment Free Remission Phase - Safety Set
Mobility · Number of participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 12 in Treatment Free Remission Phase - Safety Set
Self-Care · Number of participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 12 in Treatment Free Remission Phase - Safety Set
Usual Activities · Number of participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 12 in Treatment Free Remission Phase - Safety Set
Pain/Discomfort · Number of participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 12 in Treatment Free Remission Phase - Safety Set
Anxiety / Depresssion · Number of participants
|
3 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Nilotinib
Serious events: 19 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nilotinib
n=59 participants at risk
Nilotinib
|
|---|---|
|
Cardiac disorders
Cardiac failure
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Cardiac disorders
Coronary artery disease
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Cardiac disorders
Myocardial infarction
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Cardiac disorders
Pericardial effusion
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
2/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
General disorders
Chest discomfort
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
General disorders
Chest pain
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
General disorders
Device embolisation
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
General disorders
Ill-defined disorder
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
General disorders
Non-cardiac chest pain
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
General disorders
Pyrexia
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
General disorders
Vascular stent stenosis
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Infections and infestations
Cellulitis
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Infections and infestations
Gastroenteritis
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Infections and infestations
Influenza
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Infections and infestations
Osteomyelitis
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Infections and infestations
Wound infection
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Nervous system disorders
Cerebrovascular accident
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Nervous system disorders
Hypoaesthesia
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Nervous system disorders
Transient ischaemic attack
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Nervous system disorders
Vascular headache
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Surgical and medical procedures
Leg amputation
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Vascular disorders
Arterial stenosis
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Vascular disorders
Deep vein thrombosis
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Vascular disorders
Peripheral ischaemia
|
1.7%
1/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
Other adverse events
| Measure |
Nilotinib
n=59 participants at risk
Nilotinib
|
|---|---|
|
Cardiac disorders
Palpitations
|
5.1%
3/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Cardiac disorders
Sinus bradycardia
|
5.1%
3/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Eye disorders
Dry eye
|
6.8%
4/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.8%
4/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Gastrointestinal disorders
Abdominal distension
|
5.1%
3/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
18.6%
11/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.9%
7/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Gastrointestinal disorders
Constipation
|
28.8%
17/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
15.3%
9/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
5.1%
3/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
8.5%
5/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.1%
3/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Gastrointestinal disorders
Nausea
|
18.6%
11/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Gastrointestinal disorders
Vomiting
|
8.5%
5/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
General disorders
Fatigue
|
39.0%
23/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
General disorders
Influenza like illness
|
6.8%
4/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
General disorders
Oedema peripheral
|
8.5%
5/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
General disorders
Pain
|
5.1%
3/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
General disorders
Pyrexia
|
6.8%
4/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Infections and infestations
Bronchitis
|
5.1%
3/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Infections and infestations
Nasopharyngitis
|
10.2%
6/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Infections and infestations
Sinusitis
|
11.9%
7/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
3/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Infections and infestations
Urinary tract infection
|
8.5%
5/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
5.1%
3/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Investigations
Alanine aminotransferase increased
|
11.9%
7/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Investigations
Blood bilirubin increased
|
6.8%
4/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Investigations
Blood cholesterol increased
|
8.5%
5/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Investigations
Lipase increased
|
18.6%
11/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Investigations
Weight decreased
|
15.3%
9/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.2%
6/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.1%
3/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.9%
7/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.1%
3/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.3%
12/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.1%
3/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.9%
7/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.1%
3/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.8%
4/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.1%
3/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.5%
5/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.9%
7/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.9%
10/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Nervous system disorders
Dizziness
|
5.1%
3/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Nervous system disorders
Headache
|
23.7%
14/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Psychiatric disorders
Anxiety
|
5.1%
3/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Psychiatric disorders
Depression
|
5.1%
3/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Psychiatric disorders
Insomnia
|
10.2%
6/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.9%
7/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.5%
5/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.8%
4/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.9%
7/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.1%
3/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.6%
11/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.1%
16/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.9%
7/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
6.8%
4/59 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment or last day in TFR Phase up to approximately 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER