Trial Outcomes & Findings for Phase II Decitabine (DAC) Versus Azacitidine (AZA) in Myelodysplastic Syndrome (MDS) (NCT NCT02269280)
NCT ID: NCT02269280
Last Updated: 2025-08-07
Results Overview
Event free survival (EFS) defined as the time from beginning of treatment till an event occurs or last follow-up. For transfusion independent patients, the events includes lack of response, requirement of blood transfusion, progression to advanced stages of disease, transformation into AML, discontinuation of therapy due to side effects, and death. For transfusion dependent patients, the events includes lack of response, progression to advanced stages of disease, transformation into AML, discontinuation of therapy due to side effects, and death.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
185 participants
Primary outcome timeframe
Up to 8 years, 9 months and 12 days
Results posted on
2025-08-07
Participant Flow
Participant milestones
| Measure |
Azacitidine (AZA) - Days 1 - 3
Azacitidine (AZA) Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
Azacitidine (AZA) Days 1 - 3: Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
|
Azacitidine (AZA) - Days 1 - 5
Azacitidine (AZA) 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
Azacitidine (AZA) Days 1 - 5: Azacitidine 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
|
Decitabine (DAC)
Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
Decitabine (DAC): Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
|
Best Supportive Care (BSC)
Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.
Best Supportive Care (BSC): Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
54
|
68
|
58
|
5
|
|
Overall Study
COMPLETED
|
54
|
68
|
58
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Decitabine (DAC) Versus Azacitidine (AZA) in Myelodysplastic Syndrome (MDS)
Baseline characteristics by cohort
| Measure |
Azacitidine (AZA) - Days 1 - 3
n=54 Participants
Azacitidine (AZA) Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
Azacitidine (AZA) Days 1 - 3: Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
|
Azacitidine (AZA) - Days 1 - 5
n=68 Participants
Azacitidine (AZA) 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
Azacitidine (AZA) Days 1 - 5: Azacitidine 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
|
Decitabine (DAC)
n=58 Participants
Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
Decitabine (DAC): Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
|
Best Supportive Care (BSC)
n=5 Participants
Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.
Best Supportive Care (BSC): Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
134 Participants
n=21 Participants
|
|
Age, Continuous
|
72 years
n=5 Participants
|
70 years
n=7 Participants
|
71 years
n=5 Participants
|
67 years
n=4 Participants
|
71 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
138 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
168 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
68 participants
n=7 Participants
|
58 participants
n=5 Participants
|
5 participants
n=4 Participants
|
185 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 8 years, 9 months and 12 daysEvent free survival (EFS) defined as the time from beginning of treatment till an event occurs or last follow-up. For transfusion independent patients, the events includes lack of response, requirement of blood transfusion, progression to advanced stages of disease, transformation into AML, discontinuation of therapy due to side effects, and death. For transfusion dependent patients, the events includes lack of response, progression to advanced stages of disease, transformation into AML, discontinuation of therapy due to side effects, and death.
Outcome measures
| Measure |
Azacitidine (AZA) - Days 1 - 3
n=54 Participants
Azacitidine (AZA) Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
Azacitidine (AZA) Days 1 - 3: Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
|
Azacitidine (AZA) - Days 1 - 5
n=68 Participants
Azacitidine (AZA) 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
Azacitidine (AZA) Days 1 - 5: Azacitidine 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
|
Decitabine (DAC)
n=58 Participants
Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
Decitabine (DAC): Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
|
Best Supportive Care (BSC)
n=5 Participants
Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.
Best Supportive Care (BSC): Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.
|
|---|---|---|---|---|
|
Event Free Survival (EFS)
|
14.1 Months
Interval 1.1 to 75.4
|
18.0 Months
Interval 0.9 to 61.6
|
9.8 Months
Interval 0.8 to 31.0
|
13.3 Months
Interval 0.8 to 75.4
|
SECONDARY outcome
Timeframe: Up to 8 years, 9 months and 12 daysOverall improvement, defined as complete remission (CR), partial remission (PR), marrow CR (mCR), or hematologic improvement (HI), measured using each patient's best response with the 2 different agents. Response assessed using the modified MDS International Working Group 2006 criteria.
Outcome measures
| Measure |
Azacitidine (AZA) - Days 1 - 3
n=54 Participants
Azacitidine (AZA) Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
Azacitidine (AZA) Days 1 - 3: Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
|
Azacitidine (AZA) - Days 1 - 5
n=68 Participants
Azacitidine (AZA) 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
Azacitidine (AZA) Days 1 - 5: Azacitidine 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
|
Decitabine (DAC)
n=58 Participants
Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
Decitabine (DAC): Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
|
Best Supportive Care (BSC)
n=5 Participants
Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.
Best Supportive Care (BSC): Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.
|
|---|---|---|---|---|
|
Number of Participants With Overall Improvement
|
22 Participants
|
27 Participants
|
29 Participants
|
0 Participants
|
Adverse Events
Azacitidine (AZA) - Days 1 - 3
Serious events: 4 serious events
Other events: 35 other events
Deaths: 1 deaths
Azacitidine (AZA) - Days 1 - 5
Serious events: 3 serious events
Other events: 51 other events
Deaths: 2 deaths
Decitabine (DAC)
Serious events: 0 serious events
Other events: 38 other events
Deaths: 5 deaths
Best Supportive Care (BSC)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azacitidine (AZA) - Days 1 - 3
n=54 participants at risk
Azacitidine (AZA) Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
Azacitidine (AZA) Days 1 - 3: Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
|
Azacitidine (AZA) - Days 1 - 5
n=68 participants at risk
Azacitidine (AZA) 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
Azacitidine (AZA) Days 1 - 5: Azacitidine 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
|
Decitabine (DAC)
n=58 participants at risk
Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
Decitabine (DAC): Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
|
Best Supportive Care (BSC)
n=5 participants at risk
Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.
Best Supportive Care (BSC): Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/54 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
0.00%
0/68 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/54 • Up to 8 years, 9 months and 12 days
|
1.5%
1/68 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Cardiac disorders
Cardiac arrest
|
1.9%
1/54 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
0.00%
0/68 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/54 • Up to 8 years, 9 months and 12 days
|
1.5%
1/68 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
General disorders
Fever
|
1.9%
1/54 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
2.9%
2/68 • Number of events 2 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
1.9%
1/54 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
0.00%
0/68 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.9%
1/54 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
1.5%
1/68 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/54 • Up to 8 years, 9 months and 12 days
|
1.5%
1/68 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.9%
1/54 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
0.00%
0/68 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Infections and infestations
Lung infection
|
1.9%
1/54 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
0.00%
0/68 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Infections and infestations
Skin infection
|
0.00%
0/54 • Up to 8 years, 9 months and 12 days
|
1.5%
1/68 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
Other adverse events
| Measure |
Azacitidine (AZA) - Days 1 - 3
n=54 participants at risk
Azacitidine (AZA) Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
Azacitidine (AZA) Days 1 - 3: Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
|
Azacitidine (AZA) - Days 1 - 5
n=68 participants at risk
Azacitidine (AZA) 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
Azacitidine (AZA) Days 1 - 5: Azacitidine 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
|
Decitabine (DAC)
n=58 participants at risk
Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
Decitabine (DAC): Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
|
Best Supportive Care (BSC)
n=5 participants at risk
Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.
Best Supportive Care (BSC): Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.6%
3/54 • Number of events 4 • Up to 8 years, 9 months and 12 days
|
4.4%
3/68 • Number of events 3 • Up to 8 years, 9 months and 12 days
|
5.2%
3/58 • Number of events 5 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.3%
5/54 • Number of events 5 • Up to 8 years, 9 months and 12 days
|
5.9%
4/68 • Number of events 5 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
20.0%
1/5 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
2/54 • Number of events 2 • Up to 8 years, 9 months and 12 days
|
10.3%
7/68 • Number of events 10 • Up to 8 years, 9 months and 12 days
|
5.2%
3/58 • Number of events 3 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Eye disorders
Blurred vision
|
1.9%
1/54 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
0.00%
0/68 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
20.0%
1/5 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/54 • Up to 8 years, 9 months and 12 days
|
1.5%
1/68 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
20.0%
1/5 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
|
Gastrointestinal disorders
Constipation
|
9.3%
5/54 • Number of events 5 • Up to 8 years, 9 months and 12 days
|
13.2%
9/68 • Number of events 13 • Up to 8 years, 9 months and 12 days
|
3.4%
2/58 • Number of events 3 • Up to 8 years, 9 months and 12 days
|
40.0%
2/5 • Number of events 2 • Up to 8 years, 9 months and 12 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
3/54 • Number of events 3 • Up to 8 years, 9 months and 12 days
|
8.8%
6/68 • Number of events 6 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Gastrointestinal disorders
Diarrhea
|
7.4%
4/54 • Number of events 5 • Up to 8 years, 9 months and 12 days
|
4.4%
3/68 • Number of events 3 • Up to 8 years, 9 months and 12 days
|
3.4%
2/58 • Number of events 2 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Nervous system disorders
Dizziness
|
5.6%
3/54 • Number of events 4 • Up to 8 years, 9 months and 12 days
|
4.4%
3/68 • Number of events 7 • Up to 8 years, 9 months and 12 days
|
1.7%
1/58 • Number of events 2 • Up to 8 years, 9 months and 12 days
|
20.0%
1/5 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
|
Nervous system disorders
Dysesthesia
|
1.9%
1/54 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
0.00%
0/68 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
20.0%
1/5 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.7%
2/54 • Number of events 2 • Up to 8 years, 9 months and 12 days
|
7.4%
5/68 • Number of events 6 • Up to 8 years, 9 months and 12 days
|
1.7%
1/58 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
20.0%
1/5 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
|
General disorders
Edema limbs
|
5.6%
3/54 • Number of events 3 • Up to 8 years, 9 months and 12 days
|
10.3%
7/68 • Number of events 8 • Up to 8 years, 9 months and 12 days
|
1.7%
1/58 • Number of events 8 • Up to 8 years, 9 months and 12 days
|
20.0%
1/5 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
|
General disorders
Fatigue
|
3.7%
2/54 • Number of events 2 • Up to 8 years, 9 months and 12 days
|
13.2%
9/68 • Number of events 11 • Up to 8 years, 9 months and 12 days
|
6.9%
4/58 • Number of events 4 • Up to 8 years, 9 months and 12 days
|
20.0%
1/5 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.9%
1/54 • Number of events 2 • Up to 8 years, 9 months and 12 days
|
7.4%
5/68 • Number of events 5 • Up to 8 years, 9 months and 12 days
|
8.6%
5/58 • Number of events 8 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
General disorders
Fever
|
5.6%
3/54 • Number of events 3 • Up to 8 years, 9 months and 12 days
|
5.9%
4/68 • Number of events 5 • Up to 8 years, 9 months and 12 days
|
1.7%
1/58 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Nervous system disorders
Headache
|
5.6%
3/54 • Number of events 3 • Up to 8 years, 9 months and 12 days
|
4.4%
3/68 • Number of events 3 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/54 • Up to 8 years, 9 months and 12 days
|
0.00%
0/68 • Up to 8 years, 9 months and 12 days
|
1.7%
1/58 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
20.0%
1/5 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
|
Psychiatric disorders
Insomnia
|
3.7%
2/54 • Number of events 2 • Up to 8 years, 9 months and 12 days
|
5.9%
4/68 • Number of events 6 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Infections and infestations
Lung infection
|
7.4%
4/54 • Number of events 7 • Up to 8 years, 9 months and 12 days
|
1.5%
1/68 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
10.3%
6/58 • Number of events 6 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
5.6%
3/54 • Number of events 3 • Up to 8 years, 9 months and 12 days
|
0.00%
0/68 • Up to 8 years, 9 months and 12 days
|
3.4%
2/58 • Number of events 2 • Up to 8 years, 9 months and 12 days
|
20.0%
1/5 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
|
Gastrointestinal disorders
Nausea
|
3.7%
2/54 • Number of events 2 • Up to 8 years, 9 months and 12 days
|
5.9%
4/68 • Number of events 5 • Up to 8 years, 9 months and 12 days
|
8.6%
5/58 • Number of events 6 • Up to 8 years, 9 months and 12 days
|
20.0%
1/5 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/54 • Up to 8 years, 9 months and 12 days
|
0.00%
0/68 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
20.0%
1/5 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
7.4%
4/54 • Number of events 5 • Up to 8 years, 9 months and 12 days
|
7.4%
5/68 • Number of events 5 • Up to 8 years, 9 months and 12 days
|
5.2%
3/58 • Number of events 3 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Investigations
Neutrophil count decreased
|
18.5%
10/54 • Number of events 63 • Up to 8 years, 9 months and 12 days
|
35.3%
24/68 • Number of events 81 • Up to 8 years, 9 months and 12 days
|
22.4%
13/58 • Number of events 59 • Up to 8 years, 9 months and 12 days
|
20.0%
1/5 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
|
Cardiac disorders
Palpitations
|
3.7%
2/54 • Number of events 2 • Up to 8 years, 9 months and 12 days
|
0.00%
0/68 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
20.0%
1/5 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
|
Nervous system disorders
Paresthesia
|
1.9%
1/54 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
1.5%
1/68 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
20.0%
1/5 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
|
Infections and infestations
Platelet count decreased
|
5.6%
3/54 • Number of events 13 • Up to 8 years, 9 months and 12 days
|
19.1%
13/68 • Number of events 41 • Up to 8 years, 9 months and 12 days
|
24.1%
14/58 • Number of events 62 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/54 • Up to 8 years, 9 months and 12 days
|
1.5%
1/68 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
20.0%
1/5 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/54 • Up to 8 years, 9 months and 12 days
|
0.00%
0/68 • Up to 8 years, 9 months and 12 days
|
6.9%
4/58 • Number of events 4 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
9.3%
5/54 • Number of events 6 • Up to 8 years, 9 months and 12 days
|
7.4%
5/68 • Number of events 9 • Up to 8 years, 9 months and 12 days
|
1.7%
1/58 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
1.9%
1/54 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
5.9%
4/68 • Number of events 8 • Up to 8 years, 9 months and 12 days
|
3.4%
2/58 • Number of events 3 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
|
Renal and urinary disorders
Urinary frequency
|
1.9%
1/54 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
0.00%
0/68 • Up to 8 years, 9 months and 12 days
|
0.00%
0/58 • Up to 8 years, 9 months and 12 days
|
20.0%
1/5 • Number of events 1 • Up to 8 years, 9 months and 12 days
|
|
Investigations
White blood cell decreased
|
3.7%
2/54 • Number of events 4 • Up to 8 years, 9 months and 12 days
|
8.8%
6/68 • Number of events 21 • Up to 8 years, 9 months and 12 days
|
6.9%
4/58 • Number of events 6 • Up to 8 years, 9 months and 12 days
|
0.00%
0/5 • Up to 8 years, 9 months and 12 days
|
Additional Information
Guillermo Garcia-Mnaero
The University of Texas MD Anderson Cancer Center
Phone: 713-745-3428
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place