Trial Outcomes & Findings for Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor (NCT NCT00049127)
NCT ID: NCT00049127
Last Updated: 2019-10-21
Results Overview
The proportion of successes will be estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 90% confidence interval estimated using the Duffy-Santer algorithm. Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), \>25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
64 participants
Primary outcome timeframe
6 months
Results posted on
2019-10-21
Participant Flow
Participant milestones
| Measure |
Study 1 Arm C
Phase I patients on enzyme-inducing anticonvulsants (EIACs) and \<=2 prior regimens
Imatinib at assigned dose. Escalation of cohorts-of-3 per section 7.1 of the protocol. Assigned dose will be administered p.o. twice daily in divided doses.
|
Study 2 Arm A
Phase II patients on enzyme-inducing anticonvulsants (EIACs) and \<=2 prior regimens
Imatinib at Maximum Tolerated Dose (MTD) from Study 1 mg p.o. bid daily
|
Study 2 Arm B
Phase II patients not on enzyme-inducing anticonvulsants (EIACs) and \<=2 prior regimens
Imatinib at 300 mg b.i.d.
|
Study 3 Arm D
Phase II patients on enzyme-inducing anticonvulsants (EIACs) and \>2 prior regimens
Imatinib at Maximum Tolerated Dose (MTD) from Study 1 mg p.o. bid daily
|
Study 3 Arm E
Phase II patients not on enzyme-inducing anticonvulsants (EIACs) and \>2 prior regimens
Imatinib at 300 mg b.i.d.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
0
|
40
|
0
|
12
|
|
Overall Study
COMPLETED
|
12
|
0
|
39
|
0
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Study 1 Arm C
Phase I patients on enzyme-inducing anticonvulsants (EIACs) and \<=2 prior regimens
Imatinib at assigned dose. Escalation of cohorts-of-3 per section 7.1 of the protocol. Assigned dose will be administered p.o. twice daily in divided doses.
|
Study 2 Arm A
Phase II patients on enzyme-inducing anticonvulsants (EIACs) and \<=2 prior regimens
Imatinib at Maximum Tolerated Dose (MTD) from Study 1 mg p.o. bid daily
|
Study 2 Arm B
Phase II patients not on enzyme-inducing anticonvulsants (EIACs) and \<=2 prior regimens
Imatinib at 300 mg b.i.d.
|
Study 3 Arm D
Phase II patients on enzyme-inducing anticonvulsants (EIACs) and \>2 prior regimens
Imatinib at Maximum Tolerated Dose (MTD) from Study 1 mg p.o. bid daily
|
Study 3 Arm E
Phase II patients not on enzyme-inducing anticonvulsants (EIACs) and \>2 prior regimens
Imatinib at 300 mg b.i.d.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor
Baseline characteristics by cohort
| Measure |
Study 1 Arm C
n=12 Participants
Phase I patients on EIACs and \<=2 prior regimens
|
Study 2 Arm A
Phase II patients on EIACs and \<=2 prior regimens
|
Study 2 Arm B
n=39 Participants
Phase II patients not on EIACs and \<=2 prior regimens
|
Study 3 Arm D
Phase II patients on EIACs and \>2 prior regimens
|
Study 3 Arm E
n=12 Participants
Phase II patients not on EIACs and \>2 prior regimens
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
participants
|
45 years
n=99 Participants
|
—
|
46 years
n=206 Participants
|
—
|
47 years
n=31 Participants
|
46 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
—
|
17 Participants
n=206 Participants
|
—
|
4 Participants
n=31 Participants
|
22 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
—
|
22 Participants
n=206 Participants
|
—
|
8 Participants
n=31 Participants
|
41 Participants
n=30 Participants
|
|
Performance Score
0
|
7 participants
n=99 Participants
|
—
|
10 participants
n=206 Participants
|
—
|
6 participants
n=31 Participants
|
23 participants
n=30 Participants
|
|
Performance Score
1
|
4 participants
n=99 Participants
|
—
|
23 participants
n=206 Participants
|
—
|
4 participants
n=31 Participants
|
31 participants
n=30 Participants
|
|
Performance Score
2
|
1 participants
n=99 Participants
|
—
|
6 participants
n=206 Participants
|
—
|
2 participants
n=31 Participants
|
9 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe proportion of successes will be estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 90% confidence interval estimated using the Duffy-Santer algorithm. Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), \>25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.
Outcome measures
| Measure |
Study 1 Arm C
n=12 Participants
Phase I patients on EIACs and \<=2 prior regimens
|
Study 2 Arm A
Phase II patients on EIACs and \<=2 prior regimens
|
Study 2 Arm B
n=39 Participants
Phase II patients not on EIACs and \<=2 prior regimens
|
Study 3 Arm D
Phase II patients on EIACs and \>2 prior regimens
|
Study 3 Arm E
n=12 Participants
Phase II patients not on EIACs and \>2 prior regimens
|
|---|---|---|---|---|---|
|
6-month Progression-free Survival (PFS), Defined as a Patient Being Alive and Progression-free 183 Days After the Date of Registration.
|
33.35 percentage of patients
|
—
|
33.3 percentage of patients
|
—
|
25 percentage of patients
|
SECONDARY outcome
Timeframe: Up to 5 yearsComplete Response (CR) is defined using response criteria (the neurologic examination and the Magnetic resonance imaging (MRI) and/or Computerized Tomography (CT)), total disappearance of all tumor with patient off corticosteroids or only on adrenal replacement maintenance. Partial Response (PR) is defined using response criteria (the neurologic examination and the MRI and/or CT), \>=50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose. Regression (REGR) is defined using response criteria (the neurologic examination and the MRI and/or CT), unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose.
Outcome measures
| Measure |
Study 1 Arm C
n=12 Participants
Phase I patients on EIACs and \<=2 prior regimens
|
Study 2 Arm A
Phase II patients on EIACs and \<=2 prior regimens
|
Study 2 Arm B
n=39 Participants
Phase II patients not on EIACs and \<=2 prior regimens
|
Study 3 Arm D
Phase II patients on EIACs and \>2 prior regimens
|
Study 3 Arm E
n=12 Participants
Phase II patients not on EIACs and \>2 prior regimens
|
|---|---|---|---|---|---|
|
Confirmed Response (i.e., an Objective Status of Complete Response (CR), Partial Response (PR), or Regression (REGR) on 2 Successive Evaluations at Least 4 Weeks Apart After the Start of Study Treatment).
|
0 percentage of confirmed responses
|
—
|
5.1 percentage of confirmed responses
|
—
|
0 percentage of confirmed responses
|
SECONDARY outcome
Timeframe: Time from study registration to date of disease progression or last follow-up, assessed up to 5 yearsThe percentage of patient progression-free at 12 months, 18 months, and PFS will be estimated. Kaplan-Meier survival curves and logrank tests will be used to estimate progression-time distributions. Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), \>25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.
Outcome measures
| Measure |
Study 1 Arm C
n=12 Participants
Phase I patients on EIACs and \<=2 prior regimens
|
Study 2 Arm A
Phase II patients on EIACs and \<=2 prior regimens
|
Study 2 Arm B
n=39 Participants
Phase II patients not on EIACs and \<=2 prior regimens
|
Study 3 Arm D
Phase II patients on EIACs and \>2 prior regimens
|
Study 3 Arm E
n=12 Participants
Phase II patients not on EIACs and \>2 prior regimens
|
|---|---|---|---|---|---|
|
Percentage of Patients Progression-free
|
1.9 months
Interval 1.7 to
Upper Confidence Interval (CI) was not reached
|
—
|
4.0 months
Interval 1.9 to 6.2
|
—
|
4.5 months
Interval 2.2 to
Upper CI was not reached
|
SECONDARY outcome
Timeframe: Time from date of registration to date of death due to any cause or last follow-up, assessed up to 5 yearsKaplan-Meier survival curves and logrank tests will be used to estimate survival distributions.
Outcome measures
| Measure |
Study 1 Arm C
n=12 Participants
Phase I patients on EIACs and \<=2 prior regimens
|
Study 2 Arm A
Phase II patients on EIACs and \<=2 prior regimens
|
Study 2 Arm B
n=39 Participants
Phase II patients not on EIACs and \<=2 prior regimens
|
Study 3 Arm D
Phase II patients on EIACs and \>2 prior regimens
|
Study 3 Arm E
n=12 Participants
Phase II patients not on EIACs and \>2 prior regimens
|
|---|---|---|---|---|---|
|
Overall Time to Death
|
14.2 months
Interval 8.8 to
Upper CI was not reached
|
—
|
16.6 months
Interval 6.2 to 39.4
|
—
|
13.6 months
Interval 8.0 to
Upper CI was not reached
|
Adverse Events
Study 2 Arm A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study 2 Arm B
Serious events: 12 serious events
Other events: 37 other events
Deaths: 0 deaths
Study 1 Arm C
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Study 3 Arm D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study 3 Arm E
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study 2 Arm A
Phase II patients on EIACs and \<=2 prior regimens
|
Study 2 Arm B
n=39 participants at risk
Phase II patients not on EIACs and \<=2 prior regimens
|
Study 1 Arm C
n=12 participants at risk
Phase I patients on EIACs and \<=2 prior regimens
|
Study 3 Arm D
Phase II patients on EIACs and \>2 prior regimens
|
Study 3 Arm E
n=12 participants at risk
Phase II patients not on EIACs and \>2 prior regimens
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Cardiac disorders
Edema
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Ear and labyrinth disorders
Hearing impaired
|
—
0/0
|
0.00%
0/39
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
0.00%
0/12
|
|
Eye disorders
Vision blurred
|
—
0/0
|
0.00%
0/39
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
0.00%
0/12
|
|
Gastrointestinal disorders
Gastritis
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Gastrointestinal disorders
Mucositis oral
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
8.3%
1/12 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0
|
5.1%
2/39 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
8.3%
1/12 • Number of events 2
|
|
General disorders
Fatigue
|
—
0/0
|
5.1%
2/39 • Number of events 2
|
0.00%
0/12
|
—
0/0
|
16.7%
2/12 • Number of events 2
|
|
General disorders
General symptom
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Infections and infestations
Infection without neutropenia
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Investigations
Leukocyte count decreased
|
—
0/0
|
5.1%
2/39 • Number of events 2
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Investigations
Lymphocyte count decreased
|
—
0/0
|
5.1%
2/39 • Number of events 2
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Investigations
Neutrophil count decreased
|
—
0/0
|
5.1%
2/39 • Number of events 2
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Investigations
Platelet count decreased
|
—
0/0
|
5.1%
2/39 • Number of events 2
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
—
0/0
|
5.1%
2/39 • Number of events 3
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Dehydration
|
—
0/0
|
5.1%
2/39 • Number of events 2
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
—
0/0
|
0.00%
0/39
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
—
0/0
|
0.00%
0/39
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
—
0/0
|
0.00%
0/39
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
—
0/0
|
0.00%
0/39
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Nervous system disorders
Dizziness
|
—
0/0
|
0.00%
0/39
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Headache
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
—
0/0
|
7.7%
3/39 • Number of events 3
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Seizure
|
—
0/0
|
12.8%
5/39 • Number of events 6
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Speech disorder
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Psychiatric disorders
Confusion
|
—
0/0
|
0.00%
0/39
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Psychiatric disorders
Depression
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 2
|
|
Psychiatric disorders
Personality change
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Renal and urinary disorders
Proteinuria
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
—
0/0
|
5.1%
2/39 • Number of events 2
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
—
0/0
|
0.00%
0/39
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
—
0/0
|
5.1%
2/39 • Number of events 2
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Vascular disorders
Hemorrhage
|
—
0/0
|
7.7%
3/39 • Number of events 3
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Vascular disorders
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Vascular disorders
Hypotension
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
—
0/0
|
5.1%
2/39 • Number of events 2
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
Other adverse events
| Measure |
Study 2 Arm A
Phase II patients on EIACs and \<=2 prior regimens
|
Study 2 Arm B
n=39 participants at risk
Phase II patients not on EIACs and \<=2 prior regimens
|
Study 1 Arm C
n=12 participants at risk
Phase I patients on EIACs and \<=2 prior regimens
|
Study 3 Arm D
Phase II patients on EIACs and \>2 prior regimens
|
Study 3 Arm E
n=12 participants at risk
Phase II patients not on EIACs and \>2 prior regimens
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
—
0/0
|
33.3%
13/39 • Number of events 82
|
33.3%
4/12 • Number of events 19
|
—
0/0
|
16.7%
2/12 • Number of events 29
|
|
Blood and lymphatic system disorders
Hemoglobin for leukemia studies
|
—
0/0
|
5.1%
2/39 • Number of events 6
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemolysis
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Cardiac disorders
Edema
|
—
0/0
|
41.0%
16/39 • Number of events 84
|
16.7%
2/12 • Number of events 8
|
—
0/0
|
16.7%
2/12 • Number of events 11
|
|
Cardiac disorders
Sinus tachycardia
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Ear and labyrinth disorders
Ear disorder
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Ear and labyrinth disorders
Hearing impaired
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Endocrine disorders
Cushingoid
|
—
0/0
|
5.1%
2/39 • Number of events 3
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Eye disorders
Eye disorder
|
—
0/0
|
7.7%
3/39 • Number of events 3
|
8.3%
1/12 • Number of events 2
|
—
0/0
|
0.00%
0/12
|
|
Eye disorders
Photophobia
|
—
0/0
|
0.00%
0/39
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
0.00%
0/12
|
|
Eye disorders
Vision blurred
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Eye disorders
Watering eyes
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal pain
|
—
0/0
|
7.7%
3/39 • Number of events 4
|
8.3%
1/12 • Number of events 2
|
—
0/0
|
0.00%
0/12
|
|
Gastrointestinal disorders
Constipation
|
—
0/0
|
7.7%
3/39 • Number of events 6
|
8.3%
1/12 • Number of events 3
|
—
0/0
|
0.00%
0/12
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0
|
46.2%
18/39 • Number of events 53
|
25.0%
3/12 • Number of events 14
|
—
0/0
|
33.3%
4/12 • Number of events 13
|
|
Gastrointestinal disorders
Diarrhea patients with a colostomy
|
—
0/0
|
5.1%
2/39 • Number of events 2
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dry mouth
|
—
0/0
|
2.6%
1/39 • Number of events 35
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dyspepsia
|
—
0/0
|
15.4%
6/39 • Number of events 18
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
0.00%
0/12
|
|
Gastrointestinal disorders
Esophagitis
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Gastrointestinal disorders
Flatulence
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Gastrointestinal disorders
Mucositis oral
|
—
0/0
|
17.9%
7/39 • Number of events 10
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
—
0/0
|
38.5%
15/39 • Number of events 77
|
50.0%
6/12 • Number of events 21
|
—
0/0
|
25.0%
3/12 • Number of events 7
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0
|
25.6%
10/39 • Number of events 16
|
25.0%
3/12 • Number of events 5
|
—
0/0
|
0.00%
0/12
|
|
General disorders
Chills
|
—
0/0
|
0.00%
0/39
|
8.3%
1/12 • Number of events 5
|
—
0/0
|
0.00%
0/12
|
|
General disorders
Fatigue
|
—
0/0
|
69.2%
27/39 • Number of events 211
|
50.0%
6/12 • Number of events 29
|
—
0/0
|
50.0%
6/12 • Number of events 23
|
|
General disorders
Fever
|
—
0/0
|
5.1%
2/39 • Number of events 2
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
General disorders
General symptom
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
General disorders
Pain
|
—
0/0
|
5.1%
2/39 • Number of events 2
|
8.3%
1/12 • Number of events 4
|
—
0/0
|
0.00%
0/12
|
|
Immune system disorders
Hypersensitivity
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Infections and infestations
Infection
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Infections and infestations
Infection without neutropenia
|
—
0/0
|
17.9%
7/39 • Number of events 10
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
0.00%
0/12
|
|
Infections and infestations
Wound-infectious
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Bruising
|
—
0/0
|
2.6%
1/39 • Number of events 2
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Investigations
Alanine aminotransferase increased
|
—
0/0
|
7.7%
3/39 • Number of events 6
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Investigations
Alkaline phosphatase
|
—
0/0
|
7.7%
3/39 • Number of events 8
|
33.3%
4/12 • Number of events 15
|
—
0/0
|
0.00%
0/12
|
|
Investigations
Aspartate aminotransferase increased
|
—
0/0
|
33.3%
13/39 • Number of events 34
|
41.7%
5/12 • Number of events 8
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
—
0/0
|
7.7%
3/39 • Number of events 3
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Investigations
Creatinine increased
|
—
0/0
|
15.4%
6/39 • Number of events 16
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Investigations
Laboratory test abnormal
|
—
0/0
|
7.7%
3/39 • Number of events 4
|
8.3%
1/12 • Number of events 2
|
—
0/0
|
0.00%
0/12
|
|
Investigations
Leukocyte count decreased
|
—
0/0
|
43.6%
17/39 • Number of events 103
|
33.3%
4/12 • Number of events 13
|
—
0/0
|
25.0%
3/12 • Number of events 4
|
|
Investigations
Leukocytes for pediatric BMT studies
|
—
0/0
|
0.00%
0/39
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
0.00%
0/12
|
|
Investigations
Lymphocyte count decreased
|
—
0/0
|
0.00%
0/39
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
16.7%
2/12 • Number of events 21
|
|
Investigations
Neutrophil count decreased
|
—
0/0
|
43.6%
17/39 • Number of events 84
|
33.3%
4/12 • Number of events 13
|
—
0/0
|
25.0%
3/12 • Number of events 3
|
|
Investigations
Platelet count decreased
|
—
0/0
|
38.5%
15/39 • Number of events 97
|
33.3%
4/12 • Number of events 12
|
—
0/0
|
25.0%
3/12 • Number of events 5
|
|
Investigations
Weight gain
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Investigations
Weight loss
|
—
0/0
|
7.7%
3/39 • Number of events 14
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Anorexia
|
—
0/0
|
15.4%
6/39 • Number of events 12
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
8.3%
1/12 • Number of events 2
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
—
0/0
|
46.2%
18/39 • Number of events 45
|
66.7%
8/12 • Number of events 15
|
—
0/0
|
33.3%
4/12 • Number of events 31
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
—
0/0
|
7.7%
3/39 • Number of events 6
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
—
0/0
|
17.9%
7/39 • Number of events 19
|
16.7%
2/12 • Number of events 4
|
—
0/0
|
16.7%
2/12 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
—
0/0
|
2.6%
1/39 • Number of events 3
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
—
0/0
|
2.6%
1/39 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
—
0/0
|
25.6%
10/39 • Number of events 130
|
33.3%
4/12 • Number of events 11
|
—
0/0
|
16.7%
2/12 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
—
0/0
|
10.3%
4/39 • Number of events 18
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
—
0/0
|
10.3%
4/39 • Number of events 5
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
—
0/0
|
0.00%
0/39
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
—
0/0
|
5.1%
2/39 • Number of events 3
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
—
0/0
|
10.3%
4/39 • Number of events 16
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Nervous system disorders
Ataxia
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
16.7%
2/12 • Number of events 3
|
—
0/0
|
0.00%
0/12
|
|
Nervous system disorders
Cognitive disturbance/learning problems (for pediatrics)
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Nervous system disorders
Depressed level of consciousness
|
—
0/0
|
7.7%
3/39 • Number of events 30
|
16.7%
2/12 • Number of events 7
|
—
0/0
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
—
0/0
|
0.00%
0/39
|
16.7%
2/12 • Number of events 3
|
—
0/0
|
0.00%
0/12
|
|
Nervous system disorders
Dysgeusia
|
—
0/0
|
2.6%
1/39 • Number of events 3
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Nervous system disorders
Headache
|
—
0/0
|
10.3%
4/39 • Number of events 13
|
16.7%
2/12 • Number of events 9
|
—
0/0
|
0.00%
0/12
|
|
Nervous system disorders
Memory impairment
|
—
0/0
|
7.7%
3/39 • Number of events 5
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Nervous system disorders
Neurological disorder NOS
|
—
0/0
|
5.1%
2/39 • Number of events 9
|
8.3%
1/12 • Number of events 4
|
—
0/0
|
0.00%
0/12
|
|
Nervous system disorders
Neuropathy - cranial
|
—
0/0
|
0.00%
0/39
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
0.00%
0/12
|
|
Nervous system disorders
Peripheral motor neuropathy
|
—
0/0
|
23.1%
9/39 • Number of events 28
|
33.3%
4/12 • Number of events 9
|
—
0/0
|
66.7%
8/12 • Number of events 23
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
—
0/0
|
30.8%
12/39 • Number of events 31
|
25.0%
3/12 • Number of events 8
|
—
0/0
|
25.0%
3/12 • Number of events 21
|
|
Nervous system disorders
Seizure
|
—
0/0
|
5.1%
2/39 • Number of events 11
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Nervous system disorders
Speech disorder
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
0.00%
0/12
|
|
Psychiatric disorders
Confusion
|
—
0/0
|
5.1%
2/39 • Number of events 2
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Psychiatric disorders
Depression
|
—
0/0
|
5.1%
2/39 • Number of events 2
|
8.3%
1/12 • Number of events 3
|
—
0/0
|
0.00%
0/12
|
|
Psychiatric disorders
Insomnia
|
—
0/0
|
15.4%
6/39 • Number of events 18
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Psychiatric disorders
Personality change
|
—
0/0
|
0.00%
0/39
|
8.3%
1/12 • Number of events 2
|
—
0/0
|
0.00%
0/12
|
|
Renal and urinary disorders
Incontinence
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Renal and urinary disorders
Urinary frequency
|
—
0/0
|
5.1%
2/39 • Number of events 8
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Reproductive system and breast disorders
Irregular menstruation
|
—
0/0
|
0.00%
0/39
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
—
0/0
|
7.7%
3/39 • Number of events 8
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0
|
10.3%
4/39 • Number of events 9
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
—
0/0
|
2.6%
1/39 • Number of events 4
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
—
0/0
|
5.1%
2/39 • Number of events 20
|
0.00%
0/12
|
—
0/0
|
8.3%
1/12 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
—
0/0
|
5.1%
2/39 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
—
0/0
|
5.1%
2/39 • Number of events 25
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
—
0/0
|
2.6%
1/39 • Number of events 3
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
—
0/0
|
30.8%
12/39 • Number of events 32
|
0.00%
0/12
|
—
0/0
|
16.7%
2/12 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
—
0/0
|
0.00%
0/39
|
8.3%
1/12 • Number of events 1
|
—
0/0
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Sweating
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Vascular disorders
Flushing
|
—
0/0
|
7.7%
3/39 • Number of events 3
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
|
Vascular disorders
Hemorrhage
|
—
0/0
|
10.3%
4/39 • Number of events 18
|
16.7%
2/12 • Number of events 2
|
—
0/0
|
0.00%
0/12
|
|
Vascular disorders
Thrombosis
|
—
0/0
|
2.6%
1/39 • Number of events 1
|
0.00%
0/12
|
—
0/0
|
0.00%
0/12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60