Trial Outcomes & Findings for Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular Response (NCT NCT01827930)
NCT ID: NCT01827930
Last Updated: 2020-12-31
Results Overview
The BCR-ABL transcript rate was analysed by molecular biology by RQ-PCR at study entry, 3 months, 6 months, 9 months and 12 months. Treatment is considered effective at 12 months if: * for patients with an inclusion transcript rate less than 0.1%: the transcript rate at 12 months is less or equal to 0.001% or undetectable. * for patients with an inclusion transcript rate greater than 0.1% : the transcript rate at 12 months is less or equal to 0.1% or undetectable. If BCR-ABL transcript level was unavailable at M12, the treatment was considered ineffective.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
68 participants
Primary outcome timeframe
12 months
Results posted on
2020-12-31
Participant Flow
Participant milestones
| Measure |
Imatinib 600 (Randomized Trial)
Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po
Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib 400 (Randomized Trial)
Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib400 (Cohort)
Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate: Imatinib Mesylate for CP CML
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
19
|
|
Overall Study
COMPLETED
|
24
|
25
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Imatinib 600 (Randomized Trial)
n=24 Participants
Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po
Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib 400 (Randomized Trial)
n=25 Participants
Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib400 (Parallel Cohort)
n=19 Participants
Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate: Imatinib Mesylate for CP CML
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.6 years
n=24 Participants
|
52.7 years
n=25 Participants
|
65.3 years
n=19 Participants
|
54.5 years
n=68 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=24 Participants
|
6 Participants
n=25 Participants
|
6 Participants
n=19 Participants
|
16 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=24 Participants
|
19 Participants
n=25 Participants
|
13 Participants
n=19 Participants
|
52 Participants
n=68 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
24 participants
n=24 Participants
|
25 participants
n=25 Participants
|
19 participants
n=19 Participants
|
68 participants
n=68 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort.
The BCR-ABL transcript rate was analysed by molecular biology by RQ-PCR at study entry, 3 months, 6 months, 9 months and 12 months. Treatment is considered effective at 12 months if: * for patients with an inclusion transcript rate less than 0.1%: the transcript rate at 12 months is less or equal to 0.001% or undetectable. * for patients with an inclusion transcript rate greater than 0.1% : the transcript rate at 12 months is less or equal to 0.1% or undetectable. If BCR-ABL transcript level was unavailable at M12, the treatment was considered ineffective.
Outcome measures
| Measure |
Imatinib 600 (Randomized Trial)
n=24 Participants
Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po
Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib 400 (Randomized Trial)
n=25 Participants
Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib400 (Parallel Cohort)
n=19 Participants
Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate: Imatinib Mesylate for CP CML
|
|---|---|---|---|
|
Percentage of Patients Presenting a Decline of the BCR-ABL Transcript Rate at 12 Months From Baseline - Randomised Study
|
29.2 percentage of patients
Interval 12.6 to 51.1
|
32.0 percentage of patients
Interval 14.9 to 53.5
|
10.5 percentage of patients
Interval 1.3 to 33.1
|
SECONDARY outcome
Timeframe: 3, 6, 9 and 12 monthsPopulation: All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort.
The BCR-ABL transcript rate was analysed by molecular biology by RQ-PCR at study entry, 3 months, 6 months, 9 months and 12 months. Efficacy was also evaluated at 3, 6, 9 and 12 months in terms of decreasing the rate of BCR-ABL transcripts of 2 logarithms, relative to the initial value (inclusion). The lack of data on the transcript rate was considered as failure (no decrease).
Outcome measures
| Measure |
Imatinib 600 (Randomized Trial)
n=24 Participants
Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po
Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib 400 (Randomized Trial)
n=25 Participants
Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib400 (Parallel Cohort)
n=19 Participants
Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate: Imatinib Mesylate for CP CML
|
|---|---|---|---|
|
Rate of Decline of 2-log of the BCR-ABL Transcript Rate at 3 ,6, 9 and 12 Months From Baseline - Randomised Study
9 months
|
0 percentage of patients
insufficient number of participants with events
|
0 percentage of patients
insufficient number of participants with events
|
0 percentage of patients
insufficient number of participants with events
|
|
Rate of Decline of 2-log of the BCR-ABL Transcript Rate at 3 ,6, 9 and 12 Months From Baseline - Randomised Study
12 months
|
4.2 percentage of patients
Interval 0.1 to 21.1
|
0 percentage of patients
insufficient number of participants with events
|
0 percentage of patients
insufficient number of participants with events
|
|
Rate of Decline of 2-log of the BCR-ABL Transcript Rate at 3 ,6, 9 and 12 Months From Baseline - Randomised Study
3 months
|
4.2 percentage of patients
Interval 0.1 to 21.1
|
0 percentage of patients
insufficient number of participants with events
|
0 percentage of patients
insufficient number of participants with events
|
|
Rate of Decline of 2-log of the BCR-ABL Transcript Rate at 3 ,6, 9 and 12 Months From Baseline - Randomised Study
6 months
|
4.2 percentage of patients
Interval 0.1 to 21.1
|
0 percentage of patients
insufficient number of participants with events
|
0 percentage of patients
insufficient number of participants with events
|
SECONDARY outcome
Timeframe: 3, 6, 9 and 12 monthsPopulation: All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort.
The molecular response is defined by the measurement of BCR-ABL transcript rate by quantitative RT-PCR (RQ-PCR) on peripheral venous blood according to international standards. It is defined as: * Major Molecular Response (MMR): BRC-ABL transcript rate ≤ 0.1% * Complete Molecular Response (CMR): transcript BCR-ABL undetectable and non quantifiable.
Outcome measures
| Measure |
Imatinib 600 (Randomized Trial)
n=24 Participants
Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po
Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib 400 (Randomized Trial)
n=25 Participants
Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib400 (Parallel Cohort)
n=19 Participants
Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate: Imatinib Mesylate for CP CML
|
|---|---|---|---|
|
Molecular Response at 3, 6, 9 and 12 Months
12 months : MMR
|
83.3 percentage of patient
Interval 62.6 to 95.3
|
76.0 percentage of patient
Interval 54.9 to 90.6
|
63.2 percentage of patient
Interval 38.4 to 83.7
|
|
Molecular Response at 3, 6, 9 and 12 Months
3 months - CMR
|
12.5 percentage of patient
Interval 2.7 to 32.4
|
8.0 percentage of patient
Interval 1.0 to 26.0
|
0 percentage of patient
insufficient number of participants with events
|
|
Molecular Response at 3, 6, 9 and 12 Months
3 months : MMR
|
75.0 percentage of patient
Interval 53.3 to 90.2
|
80.0 percentage of patient
Interval 59.3 to 93.2
|
78.9 percentage of patient
Interval 54.4 to 93.9
|
|
Molecular Response at 3, 6, 9 and 12 Months
6 months : CMR
|
4.2 percentage of patient
Interval 0.1 to 21.1
|
8.0 percentage of patient
Interval 1.0 to 26.0
|
0 percentage of patient
insufficient number of participants with events
|
|
Molecular Response at 3, 6, 9 and 12 Months
6 months : MMR
|
87.5 percentage of patient
Interval 67.6 to 97.3
|
72.0 percentage of patient
Interval 50.6 to 87.9
|
73.7 percentage of patient
Interval 48.8 to 90.9
|
|
Molecular Response at 3, 6, 9 and 12 Months
9 months : CMR
|
20.8 percentage of patient
Interval 7.1 to 42.2
|
4.0 percentage of patient
Interval 0.1 to 20.4
|
5.3 percentage of patient
Interval 0.1 to 26.0
|
|
Molecular Response at 3, 6, 9 and 12 Months
9 months : MMR
|
66.7 percentage of patient
Interval 44.7 to 84.4
|
68.0 percentage of patient
Interval 46.5 to 85.1
|
68.4 percentage of patient
Interval 43.4 to 87.4
|
|
Molecular Response at 3, 6, 9 and 12 Months
12 months : CMR
|
8.3 percentage of patient
Interval 1.0 to 27.0
|
4.0 percentage of patient
Interval 0.1 to 20.4
|
5.3 percentage of patient
Interval 0.1 to 26.0
|
SECONDARY outcome
Timeframe: From date of randomization until the date of complete molecular response (up to 12 months)Population: All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort.
Time to complete molecular response was defined by the time from inclusion/randomization and the first CMR.
Outcome measures
| Measure |
Imatinib 600 (Randomized Trial)
n=24 Participants
Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po
Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib 400 (Randomized Trial)
n=25 Participants
Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib400 (Parallel Cohort)
n=18 Participants
Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate: Imatinib Mesylate for CP CML
|
|---|---|---|---|
|
Time to Complete Molecular Response (CMR) and Major Molecular Response (MMR)
CMR
|
8.7 months
Interval 3.0 to 9.1
|
3.2 months
Interval 3.1 to 5.5
|
8.9 months
Interval 8.9 to 8.9
|
|
Time to Complete Molecular Response (CMR) and Major Molecular Response (MMR)
MMR
|
3.2 months
Interval 2.7 to 6.0
|
3.2 months
Interval 2.3 to 6.1
|
3.4 months
Interval 2.1 to 9.2
|
SECONDARY outcome
Timeframe: 12 first monthsPopulation: All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort.
The BCR-ABL transcript rate was analysed by molecular biology by RQ-PCR at study entry, 3 months, 6 months, 9 months and 12 months.
Outcome measures
| Measure |
Imatinib 600 (Randomized Trial)
n=24 Participants
Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po
Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib 400 (Randomized Trial)
n=25 Participants
Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib400 (Parallel Cohort)
n=19 Participants
Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate: Imatinib Mesylate for CP CML
|
|---|---|---|---|
|
Rate of BCR-ABL Undetectable
|
29.2 percentage of patients
Interval 12.6 to 51.1
|
12.0 percentage of patients
Interval 2.5 to 31.2
|
5.3 percentage of patients
Interval 0.1 to 26.0
|
SECONDARY outcome
Timeframe: within 12 months following randomizationPopulation: All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort.
The BCR-ABL transcript rate was analysed by molecular biology by RQ-PCR at study entry, 3 months, 6 months, 9 months and 12 months. Time to the first BCR-ABL undetectable was defined by the time from inclusion/randomization and the first CMR.
Outcome measures
| Measure |
Imatinib 600 (Randomized Trial)
n=7 Participants
Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po
Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib 400 (Randomized Trial)
n=3 Participants
Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib400 (Parallel Cohort)
n=1 Participants
Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate: Imatinib Mesylate for CP CML
|
|---|---|---|---|
|
Time to the First BCR-ABL Undetectable
|
8.7 Months
Interval 3.0 to 9.1
|
3.2 Months
Interval 3.1 to 5.5
|
8.9 Months
Interval 8.9 to 8.9
|
SECONDARY outcome
Timeframe: First 12 monthsPopulation: All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort.
Overall survival is defined by the time from de date of inclusion/randomization to the date of death (of any cause).
Outcome measures
| Measure |
Imatinib 600 (Randomized Trial)
n=24 Participants
Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po
Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib 400 (Randomized Trial)
n=25 Participants
Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib400 (Parallel Cohort)
n=19 Participants
Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate: Imatinib Mesylate for CP CML
|
|---|---|---|---|
|
Overall Survival
|
NA Months
insufficient number of participants with events
|
NA Months
insufficient number of participants with events
|
NA Months
insufficient number of participants with events
|
SECONDARY outcome
Timeframe: First 12 monthsPopulation: All patients included, regardless of whether or not treatment was administered, and regardless violations of any eligibility criteria. This population corresponds to Intention to treat population for randomized study, and population assessable for the primary endpoind for the parralel cohort.
Progression-free survival was defined by the time from the date of inclusion and the date of progression. Progression was defined as : * Death, * Passage into the acceleration phase defined by one of the following criteria: % of blood or medullary blasts greater than 15% but less than 30%, blasts plus promyelocytes greater than 30% in the blood or marrow, basophils greater than 20% in the blood, thrombocytopenia less than 100x10\^9/L unrelated to treatment, clonal evolution) * Passage to the blast transformation phase defined by one of the following criteria: % of blasts of blood or bone marrow greater than 30%, occurrence of extramedullary damage other than histologically proven hepato-splenic. * Increase in BCR-ABL transcripts greater than or equal to 2-log compared to the previous values (this increase must be confirmed within 3 months).
Outcome measures
| Measure |
Imatinib 600 (Randomized Trial)
n=24 Participants
Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po
Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib 400 (Randomized Trial)
n=25 Participants
Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib400 (Parallel Cohort)
n=19 Participants
Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate: Imatinib Mesylate for CP CML
|
|---|---|---|---|
|
Progression-free Survival
|
NA Months
insufficient number of participants with events
|
NA Months
insufficient number of participants with events
|
NA Months
insufficient number of participants with events
|
Adverse Events
Imatinib 600 (Randomized Trial)
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Imatinib 400 (Randomized Trial)
Serious events: 4 serious events
Other events: 12 other events
Deaths: 1 deaths
Imatinib400 (Parallel Cohort)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Imatinib 600 (Randomized Trial)
n=24 participants at risk
Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po
Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib 400 (Randomized Trial)
n=25 participants at risk
Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib400 (Parallel Cohort)
n=19 participants at risk
Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate: Imatinib Mesylate for CP CML
|
|---|---|---|---|
|
Cardiac disorders
Cardiac General - Other (Specify, __)
|
0.00%
0/24 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
4.0%
1/25 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/19 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
4.2%
1/24 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/19 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal - Other (Specify, __)
|
0.00%
0/24 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
4.0%
1/25 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/19 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Infections and infestations
Infection - Other (Specify, __)
|
4.2%
1/24 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/19 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Injury, poisoning and procedural complications
Fracture
|
4.2%
1/24 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/19 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
0.00%
0/24 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
4.0%
1/25 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/19 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pulmonary/Upper Respiratory - Other (Specify, __)
|
0.00%
0/24 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
4.0%
1/25 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/19 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal/Genitourinary - Other (Specify, __)
|
0.00%
0/24 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
4.0%
1/25 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/19 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
Other adverse events
| Measure |
Imatinib 600 (Randomized Trial)
n=24 participants at risk
Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po
Imatinib Mesylate 600 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib 400 (Randomized Trial)
n=25 participants at risk
Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate 400 MG Oral Tablet: Imatinib Mesylate for CP CML
|
Imatinib400 (Parallel Cohort)
n=19 participants at risk
Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
Imatinib Mesylate: Imatinib Mesylate for CP CML
|
|---|---|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
4.2%
1/24 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
0.00%
0/24 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
8.3%
2/24 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
10.5%
2/19 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Investigations
Leukocytes (total WBC)
|
12.5%
3/24 • Number of events 3 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
4.0%
1/25 • Number of events 3 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Investigations
Lymphopenia
|
4.2%
1/24 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
4.0%
1/25 • Number of events 3 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
16.7%
4/24 • Number of events 4 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
4.0%
1/25 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Cardiac disorders
Cardiac General - Other (Specify, __)
|
0.00%
0/24 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
4.0%
1/25 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Vascular disorders
Hypertension
|
4.2%
1/24 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
8.0%
2/25 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
37.5%
9/24 • Number of events 10 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
12.0%
3/25 • Number of events 4 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
10.5%
2/19 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/24 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
12.5%
3/24 • Number of events 4 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
4.0%
1/25 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Skin and subcutaneous tissue disorders
Induration/fibrosis (skin and subcutaneous tissue)
|
0.00%
0/24 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
8.3%
2/24 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
6/24 • Number of events 7 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
21.1%
4/19 • Number of events 4 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
0.00%
0/24 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __)
|
8.3%
2/24 • Number of events 5 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
4.0%
1/25 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nose
|
4.2%
1/24 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Infections and infestations
Infection - Other (Specify, __)
|
25.0%
6/24 • Number of events 8 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
8.0%
2/25 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
21.1%
4/19 • Number of events 5 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
General disorders
Edema:head and neck
|
12.5%
3/24 • Number of events 6 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
General disorders
Edema:limb
|
0.00%
0/24 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
4.0%
1/25 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
General disorders
Lymphatics - Other (Specify, __)
|
0.00%
0/24 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
8.3%
2/24 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
4.0%
1/25 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
0.00%
0/24 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
37.5%
9/24 • Number of events 12 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
12.0%
3/25 • Number of events 4 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
10.5%
2/19 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Psychiatric disorders
Depression
|
8.3%
2/24 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Eye disorders
Cataract
|
0.00%
0/24 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Eye disorders
Ocular/Visual - Other (Specify, __)
|
8.3%
2/24 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
4.0%
1/25 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
10.5%
2/19 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
0.00%
0/24 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Nervous system disorders
Head/headache
|
4.2%
1/24 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
4.0%
1/25 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
10.5%
2/19 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Musculoskeletal and connective tissue disorders
Joint
|
4.2%
1/24 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
10.5%
2/19 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Gastrointestinal disorders
Stomach
|
8.3%
2/24 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
10.5%
2/19 • Number of events 2 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
4.2%
1/24 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/24 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __)
|
0.00%
0/24 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
4.0%
1/25 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
|
Vascular disorders
Carotid
|
0.00%
0/24 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
0.00%
0/25 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
5.3%
1/19 • Number of events 1 • throughout the follow-up of the patient, up to 1 year
All adverse envent (related and unrelated to treatment) were reported. All serious adverse envent (related and unrelated to treatment) were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place