Trial Outcomes & Findings for A Phase I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML (NCT NCT01861002)
NCT ID: NCT01861002
Last Updated: 2021-06-09
Results Overview
To evaluate the side effects of giving Azacytidine before and during chemotherapy using the standard drugs Fludarabine, Cytarabine, IT Cytarabine (AML patients) and IT methotrexate (ALL patients)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
From Day 1 to Day 42 (Cycle 1)
Results posted on
2021-06-09
Participant Flow
Participant milestones
| Measure |
75 mg/m2/Day Azacytidine
* Azacytidine (Dose Level @ 75 mg/m2/day),all patients will start at Dose Level 1. If 2 DLTs are observed within the first 6 patients enrolled, dose will be reduced to Dose Level 0 @ 50 mg/m2/day
* Fludarabine 30 mg/m2/dose
* Cytarabine 2000 mg/m2/dose
* Intrathecal (IT) Cytarabine
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML
Baseline characteristics by cohort
| Measure |
Dose Level 1 75 mg/m2/Day
n=14 Participants
This arm is comprised of the AML and ALL participants that completed Dose Level 1 75 mg/m2/day
|
|---|---|
|
Age, Continuous
|
9.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Central Nervous System (CNS) Status
CNS Negative
|
8 Participants
n=5 Participants
|
|
Central Nervous System (CNS) Status
CNS Positive
|
6 Participants
n=5 Participants
|
|
Bone Marrow Status (at study entry)
M2 (5-25% Leukemic Blasts)
|
5 Participants
n=5 Participants
|
|
Bone Marrow Status (at study entry)
M3 (>25% Leukemic Blasts)
|
9 Participants
n=5 Participants
|
|
# Prior treatment regimens
1 prior treatment
|
4 Participants
n=5 Participants
|
|
# Prior treatment regimens
2 prior treatments
|
4 Participants
n=5 Participants
|
|
# Prior treatment regimens
3 or more prior treatments
|
6 Participants
n=5 Participants
|
|
Prior Hematopoetic Stem Cell Transplantation (HSCT)
No Previous HSCT
|
9 Participants
n=5 Participants
|
|
Prior Hematopoetic Stem Cell Transplantation (HSCT)
Previous HSCT
|
5 Participants
n=5 Participants
|
|
White blood cell (WBC) Count
|
6.89 Thousand cells / mm^3
n=5 Participants
|
|
Peripheral blasts
|
16 Percentage of cells
n=5 Participants
|
|
Bone marrow blasts
|
68.5 Percentage of cells
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 42 (Cycle 1)To evaluate the side effects of giving Azacytidine before and during chemotherapy using the standard drugs Fludarabine, Cytarabine, IT Cytarabine (AML patients) and IT methotrexate (ALL patients)
Outcome measures
| Measure |
Dose 75 mg/m2/Day Azacytidine Diagnosed With AML
n=13 Participants
Evaluable Participants who received azacytidine @ 75 mg/m2/day (Dose Level 1)
|
Dose 75 mg/m2/Day Azacytidine Diagnosed With ALL
n=2 Participants
Evaluable ALL participants who received azacytidine @ 75 mg/m2/day (Dose Level 1)
|
|---|---|---|
|
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
# of patients not evaluable
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
# of patients with DLT
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
# of patients without DLT
|
12 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Between Days 36-42 of Courses 1 and 2CR is defined as a bone marrow with \< 5% blast by morphology, no evidence of extramedullary disease, and recovery of peripheral counts (ANC ≥ 1000/μl and platelet counts ≥ 100,000/μl). CR with incomplete count recovery (CRi) was defined as CR without recovery of ANC and/or platelets. Partial response (PR) was defined as complete disappearance of circulating blasts and a decrease of at least 50% of blasts in the bone marrow. Progressive disease (PD) was defined as an increase of at least 25% in the absolute number of bone marrow or circulating blasts, development of new sites of extramedullary disease, or other laboratory or clinical evidence of progression of disease. Stable disease (SD) referred to patient who did not satisfy the criteria for either CR, CRi, PR or PD.
Outcome measures
| Measure |
Dose 75 mg/m2/Day Azacytidine Diagnosed With AML
n=12 Participants
Evaluable Participants who received azacytidine @ 75 mg/m2/day (Dose Level 1)
|
Dose 75 mg/m2/Day Azacytidine Diagnosed With ALL
n=2 Participants
Evaluable ALL participants who received azacytidine @ 75 mg/m2/day (Dose Level 1)
|
|---|---|---|
|
Disease Response Rate After Treatment
CR with Incomplete Count Recovery (CRi)
|
1 Participants
|
0 Participants
|
|
Disease Response Rate After Treatment
Complete Remission (CR)
|
6 Participants
|
0 Participants
|
|
Disease Response Rate After Treatment
Partial Remission (PR)
|
1 Participants
|
1 Participants
|
|
Disease Response Rate After Treatment
Stable Disease (SD)
|
1 Participants
|
1 Participants
|
|
Disease Response Rate After Treatment
Progressive Disease (PD)
|
3 Participants
|
0 Participants
|
Adverse Events
AML Cohort: 75 mg/m2/Day
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
ALL Cohort: 75 mg/m2/Day
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AML Cohort: 75 mg/m2/Day
n=13 participants at risk
Any patients in the AML arm who are evaluable for toxicity. Any patient who experiences a DLT after receiving at least one dose of AZA on study will be considered evaluable for toxicity of AZA. Patients who do not experience a DLT must receive at least 80% of the prescribed course of AZA in the first cycle (i.e., must receive at least 4 of the planned 5 doses of AZA between days 1 to 5) to be evaluable for toxicity of AZA. Patients not evaluable for toxicity of AZA will be replaced.
|
ALL Cohort: 75 mg/m2/Day
n=2 participants at risk
Any patients in the ALL arm who are evaluable for toxicity. Any patient who experiences a DLT after receiving at least one dose of AZA on study will be considered evaluable for toxicity of AZA. Patients who do not experience a DLT must receive at least 80% of the prescribed course of AZA in the first cycle (i.e., must receive at least 4 of the planned 5 doses of AZA between days 1 to 5) to be evaluable for toxicity of AZA. Patients not evaluable for toxicity of AZA will be replaced.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
15.4%
2/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
50.0%
1/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
General disorders
Fever
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
50.0%
1/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
15.4%
2/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Infections and infestations
Sepsis
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
Other adverse events
| Measure |
AML Cohort: 75 mg/m2/Day
n=13 participants at risk
Any patients in the AML arm who are evaluable for toxicity. Any patient who experiences a DLT after receiving at least one dose of AZA on study will be considered evaluable for toxicity of AZA. Patients who do not experience a DLT must receive at least 80% of the prescribed course of AZA in the first cycle (i.e., must receive at least 4 of the planned 5 doses of AZA between days 1 to 5) to be evaluable for toxicity of AZA. Patients not evaluable for toxicity of AZA will be replaced.
|
ALL Cohort: 75 mg/m2/Day
n=2 participants at risk
Any patients in the ALL arm who are evaluable for toxicity. Any patient who experiences a DLT after receiving at least one dose of AZA on study will be considered evaluable for toxicity of AZA. Patients who do not experience a DLT must receive at least 80% of the prescribed course of AZA in the first cycle (i.e., must receive at least 4 of the planned 5 doses of AZA between days 1 to 5) to be evaluable for toxicity of AZA. Patients not evaluable for toxicity of AZA will be replaced.
|
|---|---|---|
|
Investigations
GGT increased
|
23.1%
3/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.4%
2/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Eye disorders
Eye disorders - Other, specify
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Nervous system disorders
Headache
|
30.8%
4/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Renal and urinary disorders
Hematuria
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Eye disorders
Eye pain
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
General disorders
Fatigue
|
15.4%
2/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
69.2%
9/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
100.0%
2/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
General disorders
Fever
|
76.9%
10/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Investigations
Fibrinogen decreased
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Abdominal pain
|
46.2%
6/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
15.4%
2/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Investigations
Alanine aminotransferase increased
|
84.6%
11/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
50.0%
1/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Investigations
Alkaline phosphatase increased
|
15.4%
2/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Immune system disorders
Allergic reaction
|
23.1%
3/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Anal pain
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Blood and lymphatic system disorders
Anemia
|
76.9%
10/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
100.0%
2/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Anorexia
|
38.5%
5/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Investigations
Aspartate aminotransferase increased
|
84.6%
11/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
50.0%
1/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Investigations
Blood bilirubin increased
|
30.8%
4/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Injury, poisoning and procedural complications
Bruising
|
38.5%
5/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
General disorders
Chills
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Investigations
Cholesterol high
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Eye disorders
Conjunctivitis
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Constipation
|
53.8%
7/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Investigations
Creatinine increased
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Dental caries
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Diarrhea
|
38.5%
5/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Nervous system disorders
Dizziness
|
23.1%
3/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Eye disorders
Dry eye
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
General disorders
Edema face
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
53.8%
7/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
46.2%
6/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
23.1%
3/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
23.1%
3/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
76.9%
10/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
100.0%
13/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
46.2%
6/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
46.2%
6/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
50.0%
1/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
38.5%
5/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
50.0%
1/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
30.8%
4/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
50.0%
1/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Injury, poisoning and procedural complications
Infusion site extravasation
|
15.4%
2/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Injury, poisoning and procedural complications
Injury, poisoning & proc complications - Other
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Investigations
INR increased
|
15.4%
2/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Investigations
Investigations - Other, specify
|
15.4%
2/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Psychiatric disorders
Irritability
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
50.0%
1/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
30.8%
4/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Reproductive system and breast disorders
Menorrhagia
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
50.0%
1/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Mucositis oral
|
30.8%
4/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Infections and infestations
Nail infection
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Nausea
|
92.3%
12/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
23.1%
3/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
84.6%
11/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
50.0%
1/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
General disorders
Non-cardiac chest pain
|
23.1%
3/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
50.0%
1/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Anal Fissure
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Erythema & Swelling
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Gum Bleeding
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
General disorders
Pain
|
46.2%
6/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.4%
2/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Eye disorders
Photophobia
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
92.3%
12/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
100.0%
2/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.8%
4/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic & mediastinal disorder-Other
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Investigations
Serum amylase increased
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Cardiac disorders
Sinus bradycardia
|
23.1%
3/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Cardiac disorders
Sinus tachycardia
|
23.1%
3/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorder-Other
|
46.2%
6/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
15.4%
2/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Stomach pain
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Toothache
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Renal and urinary disorders
Urinary tract infection
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Vomiting
|
61.5%
8/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Weight gain
|
7.7%
1/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Weight loss
|
15.4%
2/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
0.00%
0/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
|
Investigations
White blood cell decreased
|
84.6%
11/13 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
100.0%
2/2 • From date of first dose of AZA until 30 days following the last dose of protocol therapy (approximately from Day 0 to Day 112)
The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
|
Additional Information
Roy Leong, BA, CCRP
Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) / Children's Hospital Los Angeles
Phone: 323-361-5132
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60