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An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02472145
Recruitment Status : Completed
First Posted : June 15, 2015
Results First Posted : February 28, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia, Myeloid, Acute
Interventions Drug: Decitabine 20 mg/m^2
Drug: Talacotuzumab 9 mg/kg
Enrollment 326
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Part A: Decitabine + JNJ-56022473 Part B: Decitabine (Alone) Part B: Decitabine + JNJ-56022473
Hide Arm/Group Description Participants received 1 dose of JNJ-56022473 (talacotuzumab) at 9 milligram per kilogram (mg/kg) as intravenous (IV) infusion on Day 1 of cycle 1. From cycle 2 onwards, participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death. Participants received decitabine 20 mg/m^2 IV on Days 1 to 5 of each 28-day cycle until treatment failure, relapse from CR or CRi, unacceptable toxicity, or death. Participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death.
Period Title: Overall Study
Started 10 159 157
Treated 10 156 156
Safety 10 165 [1] 147 [2]
Completed 0 0 0
Not Completed 10 159 157
Reason Not Completed
Death             10             101             99
Lost to Follow-up             0             1             0
Withdrawal by Subject             0             9             13
Sponsor decision             0             3             2
Other             0             45             43
[1]
9 participants who received decitabine,not JNJ-56022473 included,3 untreated participant excluded.
[2]
1 participant who was not treated and 9 participants who received only decitabine were excluded.
Arm/Group Title Part A: Decitabine + JNJ-56022473 Part B: Decitabine (Alone) Part B: Decitabine + JNJ-56022473 Total
Hide Arm/Group Description Participants received 1 dose of JNJ-56022473 (talacotuzumab) at 9 milligram per kilogram (mg/kg) as intravenous (IV) infusion on Day 1 of cycle 1. From cycle 2 onwards, participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death. Participants received decitabine 20 mg/m^2 IV on Days 1 to 5 of each 28-day cycle until treatment failure, relapse from CR or CRi, unacceptable toxicity, or death. Participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death. Total of all reporting groups
Overall Number of Baseline Participants 10 159 157 326
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 159 participants 157 participants 326 participants
65.4  (10.88) 75  (5.6) 75.2  (5.32) 74.8  (5.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 159 participants 157 participants 326 participants
Female
4
  40.0%
68
  42.8%
77
  49.0%
149
  45.7%
Male
6
  60.0%
91
  57.2%
80
  51.0%
177
  54.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 159 participants 157 participants 326 participants
Hispanic or Latino
0
   0.0%
4
   2.5%
5
   3.2%
9
   2.8%
Not Hispanic or Latino
10
 100.0%
143
  89.9%
143
  91.1%
296
  90.8%
Unknown or Not Reported
0
   0.0%
12
   7.5%
9
   5.7%
21
   6.4%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 158 participants 157 participants 325 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
14
   8.9%
11
   7.0%
25
   7.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
   1.3%
1
   0.6%
3
   0.9%
White
10
 100.0%
133
  84.2%
141
  89.8%
284
  87.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
9
   5.7%
4
   2.5%
13
   4.0%
[1]
Measure Analysis Population Description: All participants randomized into the study, grouped per treatment assigned by randomization, regardless of the actual treatment received. Here, 'N' (number of participant analyzed) signifies number of participants who were evaluable for this baseline measure.
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian Number Analyzed 10 participants 159 participants 157 participants 326 participants
0
   0.0%
14
   8.8%
11
   7.0%
25
   7.7%
Black or African American Number Analyzed 10 participants 159 participants 157 participants 326 participants
0
   0.0%
2
   1.3%
1
   0.6%
3
   0.9%
Hispanic or Latino Number Analyzed 10 participants 159 participants 157 participants 326 participants
0
   0.0%
3
   1.9%
5
   3.2%
8
   2.5%
Other Number Analyzed 10 participants 159 participants 157 participants 326 participants
0
   0.0%
13
   8.2%
9
   5.7%
22
   6.7%
White Non-Hispanic Number Analyzed 10 participants 159 participants 157 participants 326 participants
10
 100.0%
127
  79.9%
131
  83.4%
268
  82.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Australia Number Analyzed 10 participants 159 participants 157 participants 326 participants
0
   0.0%
10
   6.3%
18
  11.5%
28
   8.6%
Belgium Number Analyzed 10 participants 159 participants 157 participants 326 participants
3
  30.0%
11
   6.9%
6
   3.8%
20
   6.1%
France Number Analyzed 10 participants 159 participants 157 participants 326 participants
0
   0.0%
6
   3.8%
2
   1.3%
8
   2.5%
Germany Number Analyzed 10 participants 159 participants 157 participants 326 participants
0
   0.0%
14
   8.8%
18
  11.5%
32
   9.8%
Israel Number Analyzed 10 participants 159 participants 157 participants 326 participants
0
   0.0%
18
  11.3%
11
   7.0%
29
   8.9%
Italy Number Analyzed 10 participants 159 participants 157 participants 326 participants
0
   0.0%
12
   7.5%
11
   7.0%
23
   7.1%
Poland Number Analyzed 10 participants 159 participants 157 participants 326 participants
0
   0.0%
13
   8.2%
11
   7.0%
24
   7.4%
Russia Number Analyzed 10 participants 159 participants 157 participants 326 participants
0
   0.0%
30
  18.9%
26
  16.6%
56
  17.2%
Spain Number Analyzed 10 participants 159 participants 157 participants 326 participants
7
  70.0%
17
  10.7%
19
  12.1%
43
  13.2%
Sweden Number Analyzed 10 participants 159 participants 157 participants 326 participants
0
   0.0%
2
   1.3%
0
   0.0%
2
   0.6%
Taiwan, Province Of China Number Analyzed 10 participants 159 participants 157 participants 326 participants
0
   0.0%
8
   5.0%
4
   2.5%
12
   3.7%
Turkey Number Analyzed 10 participants 159 participants 157 participants 326 participants
0
   0.0%
2
   1.3%
5
   3.2%
7
   2.1%
United Kingdom Number Analyzed 10 participants 159 participants 157 participants 326 participants
0
   0.0%
1
   0.6%
3
   1.9%
4
   1.2%
United States Number Analyzed 10 participants 159 participants 157 participants 326 participants
0
   0.0%
10
   6.3%
16
  10.2%
26
   8.0%
Korea, Republic Of Number Analyzed 10 participants 159 participants 157 participants 326 participants
0
   0.0%
5
   3.1%
7
   4.5%
12
   3.7%
1.Primary Outcome
Title Part B: Percentage of Participants Who Achieved Complete Response (Complete Response Rate) Based on Investigator Assessment
Hide Description Complete response rate defined as percentage of participants who achieved complete response as per modified International Working Group (IWG) criteria. CR: Bone marrow blasts less than (<)5 percent (%); absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (>)1.0*10^9/liter (L) (1000/micro liter [mcL]); platelet count >100*10^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis.
Time Frame Approximately up to 2.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population is defined as all randomized participants, grouped per treatment assigned by randomization, regardless of the actual treatment received.
Arm/Group Title Part B: Decitabine (Alone) Part B: Decitabine + JNJ-56022473
Hide Arm/Group Description:
Participants received decitabine 20 mg/m^2 IV on Days 1 to 5 of each 28-day cycle until treatment failure, relapse from CR or CRi, unacceptable toxicity, or death.
Participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death.
Overall Number of Participants Analyzed 159 157
Measure Type: Number
Unit of Measure: Percentage of participants
11.9 16.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B: Decitabine (Alone), Part B: Decitabine + JNJ-56022473
Comments Statistical Analysis 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4747
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
0.8 to 2.8
Estimation Comments [Not Specified]
2.Primary Outcome
Title Part B: Overall Survival
Hide Description Overall Survival (OS) was defined as the time from the date of randomization to date of death from any cause. Median Overall Survival was estimated by using the Kaplan-Meier method. This endpoint is reported here for Part B only as per the planned analysis.
Time Frame Approximately up to 2.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population is defined as all randomized participants, grouped per treatment assigned by randomization, regardless of the actual treatment received.
Arm/Group Title Part B: Decitabine (Alone) Part B: Decitabine + JNJ-56022473
Hide Arm/Group Description:
Participants received decitabine 20 mg/m^2 IV on Days 1 to 5 of each 28-day cycle until treatment failure, relapse from CR or CRi, unacceptable toxicity, or death.
Participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death.
Overall Number of Participants Analyzed 159 157
Median (95% Confidence Interval)
Unit of Measure: Months
7.26
(6.47 to 8.64)
5.36
(4.27 to 7.95)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B: Decitabine (Alone), Part B: Decitabine + JNJ-56022473
Comments Statistical Analysis 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7817
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.79 to 1.37
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Part B: Event-free Survival (EFS) Based on Investigator Assessment
Hide Description EFS defined as time from randomization to treatment failure, relapse from CR/CRi, or death from any cause, whichever occurs first, per modified IWG criteria. Treatment failure: >25% absolute increase in the bone marrow blast count from baseline to present assessment (example, 20% to 46%) on bone marrow aspirate (or biopsy in case of dry tap); Relapse: Bone marrow blasts greater than equal to (>=)5%; reappearance of blasts in blood; or development of extramedullary disease; CR: Bone marrow blasts <5 %; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0*10^9/L (1000/mcL); platelet count >100*10^9/L (100 000/mcL);independence of red cell transfusions; CRi: Bone marrow blasts <5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia <1.0*10^9/L (1000/mcL) or thrombocytopenia <100*10^9/L (100 000/mcL); independence of red cell transfusions. Endpoint reported is for Part B only as per planned analysis.
Time Frame Approximately up to 2.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as all randomized participants, grouped per treatment assigned by randomization, regardless of actual treatment received.
Arm/Group Title Part B: Decitabine (Alone) Part B: Decitabine + JNJ-56022473
Hide Arm/Group Description:
Participants received decitabine 20 mg/m^2 IV on Days 1 to 5 of each 28-day cycle until treatment failure, relapse from CR or CRi, unacceptable toxicity, or death.
Participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death.
Overall Number of Participants Analyzed 159 157
Median (95% Confidence Interval)
Unit of Measure: Months
6.24
(4.96 to 6.83)
4.50
(3.61 to 6.74)
4.Secondary Outcome
Title Part B: Percentage of Participants Who Achieved CR and CRi (Overall Response Rate)
Hide Description Percentage of participants who achieved CR and CRi, as per modified IWG criteria. CR: Bone marrow blasts less than (<)5 %; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (>)1.0 *10^9/liter (L) (1000/ mcL); platelet count >100 *10^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts <5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia <1.0*10^9/L (1000/mcL) or thrombocytopenia <100*10^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis.
Time Frame Approximately up to 2.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population is defined as all randomized participants, grouped per treatment assigned by randomization, regardless of the actual treatment received.
Arm/Group Title Part B: Decitabine (Alone) Part B: Decitabine + JNJ-56022473
Hide Arm/Group Description:
Participants received decitabine 20 mg/m^2 IV on Days 1 to 5 of each 28-day cycle until treatment failure, relapse from CR or CRi, unacceptable toxicity, or death.
Participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death.
Overall Number of Participants Analyzed 159 157
Measure Type: Number
Unit of Measure: Percentage of Participants
20.1 26.8
5.Secondary Outcome
Title Part B: Percentage of Participants With Complete Response (CR) Plus Minimal Residual Disease (MRD) Negative Complete Response With Incomplete Recovery (CRi)
Hide Description Percentage of participants who achieved CR plus MRD-negative CRi were reported. MRD negativity defined as <1 blast or leukemic stem cell in 10,000 leukocytes (MRD level <10^4).CR: Bone marrow blasts less than (<)5 percent (%); absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (>)1.0*10^9/liter (L) (1000/mcL); platelet count >100*10^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts <5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia <1.0*10^9/L (1000/mcL) or thrombocytopenia <100*10^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis.
Time Frame Approximately 2.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Population included participants in ITT, among whom MRD negativity was evaluated upon achieving response.
Arm/Group Title Part B: Decitabine (Alone) Part B: Decitabine + JNJ-56022473
Hide Arm/Group Description:
Participants received decitabine 20 mg/m^2 IV on Days 1 to 5 of each 28-day cycle until treatment failure, relapse from CR or CRi, unacceptable toxicity, or death.
Participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death.
Overall Number of Participants Analyzed 80 80
Measure Type: Number
Unit of Measure: Percentage of participants
13.8 21.3
6.Secondary Outcome
Title Part B: Time to Best Response
Hide Description Time to best response is calculated as the time from the randomization date to the first documented date for the best response for participants who achieved CR or CRi, as per modified IWG criteria. CR: Bone marrow blasts less than (<)5 %; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (>)1.0 *10^9/liter (L) (1000/mcL); platelet count >100*10^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts <5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia <1.0*10^9/L (1000/mcL) or thrombocytopenia <100*10^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis.
Time Frame Approximately 2.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Population included participants in ITT, who achieved CR or CRi.
Arm/Group Title Part B: Decitabine (Alone) Part B: Decitabine + JNJ-56022473
Hide Arm/Group Description:
Participants received decitabine 20 mg/m^2 IV on Days 1 to 5 of each 28-day cycle until treatment failure, relapse from CR or CRi, unacceptable toxicity, or death.
Participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death.
Overall Number of Participants Analyzed 32 42
Median (Full Range)
Unit of Measure: Weeks
16.71
(7.1 to 41.6)
18.14
(7.3 to 68.4)
7.Secondary Outcome
Title Part B: Duration of Response (DOR) Based on Investigator Assessment
Hide Description DOR defined as number of weeks from documented best response (CR or CRi) for participants who achieved CR or CRi to relapse, death due to relapse, date of censoring. As per modified IWG criteria: CR: Bone marrow blasts <5 %; absence of blasts with Auer rods; absence of extramedullary disease;absolute neutrophil count >1.0*10^9/L (1000/mcL); platelet count >100*10^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts <5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia <1.0* 10^9/L (1000/mcL) or thrombocytopenia <100*10^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis.
Time Frame Approximately 2.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Population included participants in ITT, who achieved CR or CRi.
Arm/Group Title Part B: Decitabine (Alone) Part B: Decitabine + JNJ-56022473
Hide Arm/Group Description:
Participants received decitabine 20 mg/m^2 IV on Days 1 to 5 of each 28-day cycle until treatment failure, relapse from CR or CRi, unacceptable toxicity, or death.
Participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death.
Overall Number of Participants Analyzed 32 42
Median (95% Confidence Interval)
Unit of Measure: Weeks
23.71 [1] 
(15.43 to NA)
NA [2] 
(29.86 to NA)
[1]
Upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of events.
[2]
Median and upper limit of 95% CI was not estimable due to insufficient number of events.
Time Frame Throughout the study (Up to 2.5 years)
Adverse Event Reporting Description Safety Population defined as randomized participants who received at least one dose of study medication, grouped according to actual treatment received (9 participants from decitabine + JNJ-56022473 arm were grouped in the decitabine alone arm as they received only decitabine and not JNJ 56022473). All-cause mortality is reported here for randomized participants. Serious and Other (Not including Serious) Adverse Events are reported for Safety Population per planned analysis.
 
Arm/Group Title Part A: Decitabine + JNJ-56022473 Part B: Decitabine (Alone) Part B: Decitabine + JNJ-56022473
Hide Arm/Group Description Participants received 1 dose of JNJ-56022473 (talacotuzumab) at 9 milligram per kilogram (mg/kg) as intravenous (IV) infusion on Day 1 of cycle 1. From cycle 2 onwards, participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death. Participants received decitabine 20 mg/m^2 IV on Days 1 to 5 of each 28-day cycle until treatment failure, relapse from CR or CRi, unacceptable toxicity, or death. Participants received decitabine 20 milligram per meter square (mg/m^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death.
All-Cause Mortality
Part A: Decitabine + JNJ-56022473 Part B: Decitabine (Alone) Part B: Decitabine + JNJ-56022473
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/10 (100.00%)   101/159 (63.52%)   99/157 (63.06%) 
Hide Serious Adverse Events
Part A: Decitabine + JNJ-56022473 Part B: Decitabine (Alone) Part B: Decitabine + JNJ-56022473
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/10 (90.00%)   120/165 (72.73%)   126/147 (85.71%) 
Blood and lymphatic system disorders       
Anaemia * 1  0/10 (0.00%)  6/165 (3.64%)  4/147 (2.72%) 
Disseminated Intravascular Coagulation * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Febrile Bone Marrow Aplasia * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Febrile Neutropenia * 1  2/10 (20.00%)  36/165 (21.82%)  40/147 (27.21%) 
Leukocytosis * 1  0/10 (0.00%)  0/165 (0.00%)  2/147 (1.36%) 
Neutropenia * 1  0/10 (0.00%)  0/165 (0.00%)  2/147 (1.36%) 
Pancytopenia * 1  0/10 (0.00%)  2/165 (1.21%)  2/147 (1.36%) 
Splenomegaly * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Thrombocytopenia * 1  0/10 (0.00%)  5/165 (3.03%)  3/147 (2.04%) 
Cardiac disorders       
Acute Myocardial Infarction * 1  0/10 (0.00%)  1/165 (0.61%)  3/147 (2.04%) 
Angina Pectoris * 1  0/10 (0.00%)  0/165 (0.00%)  2/147 (1.36%) 
Arrhythmia * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Atrial Fibrillation * 1  0/10 (0.00%)  2/165 (1.21%)  5/147 (3.40%) 
Bradycardia * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Cardiac Arrest * 1  0/10 (0.00%)  1/165 (0.61%)  5/147 (3.40%) 
Cardiac Failure * 1  0/10 (0.00%)  2/165 (1.21%)  0/147 (0.00%) 
Cardiac Failure Acute * 1  0/10 (0.00%)  2/165 (1.21%)  0/147 (0.00%) 
Cardiogenic Shock * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Cardiopulmonary Failure * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Cardiovascular Insufficiency * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Myocardial Ischaemia * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Pericardial Effusion * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Supraventricular Tachycardia * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Tachycardia * 1  0/10 (0.00%)  0/165 (0.00%)  3/147 (2.04%) 
Ear and labyrinth disorders       
Ear Pain * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Eye disorders       
Diplopia * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Gastrointestinal disorders       
Abdominal Pain Upper * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Acute Abdomen * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Anal Ulcer * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Colitis * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Colitis Ulcerative * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Constipation * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Diarrhoea * 1  0/10 (0.00%)  3/165 (1.82%)  2/147 (1.36%) 
Diverticular Perforation * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Diverticulum Intestinal * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Dyspepsia * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Gastritis * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Gastritis Erosive * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Gastrointestinal Angiodysplasia * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Gastrointestinal Haemorrhage * 1  0/10 (0.00%)  0/165 (0.00%)  2/147 (1.36%) 
Gastrointestinal Inflammation * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Gastrointestinal Polyp Haemorrhage * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Intestinal Haemorrhage * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Large Intestinal Obstruction * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Mechanical Ileus * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Nausea * 1  0/10 (0.00%)  1/165 (0.61%)  3/147 (2.04%) 
Oesophagitis * 1  0/10 (0.00%)  0/165 (0.00%)  2/147 (1.36%) 
Pancreatitis Acute * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Rectal Haemorrhage * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Small Intestinal Obstruction * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Vomiting * 1  1/10 (10.00%)  1/165 (0.61%)  2/147 (1.36%) 
Gastric Haemorrhage * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
Upper Gastrointestinal Haemorrhage * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
General disorders       
Asthenia * 1  0/10 (0.00%)  0/165 (0.00%)  3/147 (2.04%) 
Catheter Site Inflammation * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Chest Pain * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Chills * 1  0/10 (0.00%)  0/165 (0.00%)  3/147 (2.04%) 
Death * 1  0/10 (0.00%)  2/165 (1.21%)  0/147 (0.00%) 
Fatigue * 1  0/10 (0.00%)  0/165 (0.00%)  3/147 (2.04%) 
General Physical Health Deterioration * 1  1/10 (10.00%)  6/165 (3.64%)  4/147 (2.72%) 
Hyperthermia * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Influenza Like Illness * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Malaise * 1  0/10 (0.00%)  1/165 (0.61%)  2/147 (1.36%) 
Multiple Organ Dysfunction Syndrome * 1  0/10 (0.00%)  9/165 (5.45%)  9/147 (6.12%) 
Pyrexia * 1  1/10 (10.00%)  9/165 (5.45%)  15/147 (10.20%) 
Sudden Death * 1  0/10 (0.00%)  5/165 (3.03%)  1/147 (0.68%) 
Condition Aggravated * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
Hepatobiliary disorders       
Cholangitis * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Cholangitis Acute * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Cholecystitis * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Cholecystitis Acute * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Immune system disorders       
Anaphylactic Reaction * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Anaphylactic Shock * 1  0/10 (0.00%)  0/165 (0.00%)  2/147 (1.36%) 
Serum Sickness * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Infections and infestations       
Actinomycotic Pulmonary Infection * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Alveolar Osteitis * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Anal Infection * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Aspergillus Infection * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Bacteraemia * 1  0/10 (0.00%)  2/165 (1.21%)  1/147 (0.68%) 
Bacterial Sepsis * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Bronchitis * 1  0/10 (0.00%)  0/165 (0.00%)  2/147 (1.36%) 
Bronchopulmonary Aspergillosis * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Candida Infection * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Catheter Site Infection * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Cellulitis * 1  0/10 (0.00%)  2/165 (1.21%)  3/147 (2.04%) 
Clostridial Infection * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Clostridium Difficile Colitis * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Clostridium Difficile Infection * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Device Related Infection * 1  2/10 (20.00%)  3/165 (1.82%)  3/147 (2.04%) 
Device Related Sepsis * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Diverticulitis * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Enterobacter Bacteraemia * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Escherichia Bacteraemia * 1  0/10 (0.00%)  0/165 (0.00%)  3/147 (2.04%) 
Escherichia Infection * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Escherichia Sepsis * 1  2/10 (20.00%)  0/165 (0.00%)  2/147 (1.36%) 
Escherichia Urinary Tract Infection * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Fungaemia * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Gastroenteritis * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Gastroenteritis Rotavirus * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Gastroenteritis Viral * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Gastrointestinal Candidiasis * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Hepatic Infection Fungal * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Infected Skin Ulcer * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Infection * 1  0/10 (0.00%)  0/165 (0.00%)  3/147 (2.04%) 
Infectious Colitis * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Influenza * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Klebsiella Infection * 1  0/10 (0.00%)  0/165 (0.00%)  2/147 (1.36%) 
Liver Abscess * 1  0/10 (0.00%)  2/165 (1.21%)  0/147 (0.00%) 
Localised Infection * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Lower Respiratory Tract Infection * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Lung Infection * 1  4/10 (40.00%)  5/165 (3.03%)  3/147 (2.04%) 
Meningitis * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Moraxella Infection * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Neutropenic Sepsis * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Oral Candidiasis * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Parainfluenzae Virus Infection * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Parotitis * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Periorbital Cellulitis * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Pneumocystis Jirovecii Pneumonia * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Pneumonia * 1  0/10 (0.00%)  23/165 (13.94%)  24/147 (16.33%) 
Pneumonia Fungal * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Pseudomembranous Colitis * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Pulmonary Mycosis * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Pyelonephritis Acute * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Pyelonephritis Chronic * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Rash Pustular * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Respiratory Tract Infection * 1  0/10 (0.00%)  0/165 (0.00%)  4/147 (2.72%) 
Rhinovirus Infection * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Sepsis * 1  2/10 (20.00%)  6/165 (3.64%)  14/147 (9.52%) 
Septic Encephalopathy * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Septic Shock * 1  0/10 (0.00%)  2/165 (1.21%)  8/147 (5.44%) 
Sinusitis Fungal * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Skin Infection * 1  1/10 (10.00%)  1/165 (0.61%)  1/147 (0.68%) 
Splenic Abscess * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Staphylococcal Infection * 1  1/10 (10.00%)  1/165 (0.61%)  0/147 (0.00%) 
Staphylococcal Sepsis * 1  0/10 (0.00%)  0/165 (0.00%)  2/147 (1.36%) 
Tooth Abscess * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Tooth Infection * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Urinary Tract Infection * 1  0/10 (0.00%)  4/165 (2.42%)  6/147 (4.08%) 
Urosepsis * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Viral Infection * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Vulval Cellulitis * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Injury, poisoning and procedural complications       
Contusion * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Fall * 1  0/10 (0.00%)  3/165 (1.82%)  4/147 (2.72%) 
Femoral Neck Fracture * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Femur Fracture * 1  0/10 (0.00%)  2/165 (1.21%)  0/147 (0.00%) 
Head Injury * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Hip Fracture * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Humerus Fracture * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Spinal Compression Fracture * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Transfusion Reaction * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Transfusion-Related Acute Lung Injury * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Traumatic Haematoma * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Investigations       
Alanine Aminotransferase Increased * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Aspartate Aminotransferase Increased * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Blood Alkaline Phosphatase Increased * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Blood Lactate Dehydrogenase Increased * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
C-Reactive Protein Increased * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Gamma-Glutamyltransferase Increased * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Metabolism and nutrition disorders       
Hyperglycaemia * 1  0/10 (0.00%)  0/165 (0.00%)  2/147 (1.36%) 
Hyperuricaemia * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Hypokalaemia * 1  1/10 (10.00%)  0/165 (0.00%)  1/147 (0.68%) 
Hyponatraemia * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Hypovolaemia * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Hypomagnesaemia * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthritis * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Bursitis * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Chondrocalcinosis Pyrophosphate * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Muscular Weakness * 1  0/10 (0.00%)  2/165 (1.21%)  0/147 (0.00%) 
Pain in Extremity * 1  0/10 (0.00%)  1/165 (0.61%)  2/147 (1.36%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Acute Myeloid Leukaemia * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Bladder Neoplasm * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Central Nervous System Leukaemia * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Chloroma * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Rectal Adenoma * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Transitional Cell Carcinoma * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Adenocarcinoma Gastric * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
Nervous system disorders       
Cerebrovascular Accident * 1  0/10 (0.00%)  1/165 (0.61%)  3/147 (2.04%) 
Dizziness * 1  0/10 (0.00%)  2/165 (1.21%)  2/147 (1.36%) 
Epilepsy * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Haemorrhage Intracranial * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Haemorrhagic Stroke * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Ischaemic Stroke * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Lethargy * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Paraesthesia * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Peripheral Sensory Neuropathy * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Presyncope * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Quadriparesis * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Seizure * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Syncope * 1  0/10 (0.00%)  1/165 (0.61%)  4/147 (2.72%) 
Transient Ischaemic Attack * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Vascular Encephalopathy * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Renal and urinary disorders       
Acute Kidney Injury * 1  0/10 (0.00%)  0/165 (0.00%)  4/147 (2.72%) 
Anuria * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Calculus Urinary * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Oliguria * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Renal Impairment * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Urinary Retention * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Respiratory, thoracic and mediastinal disorders       
Acute Pulmonary Oedema * 1  0/10 (0.00%)  0/165 (0.00%)  2/147 (1.36%) 
Acute Respiratory Distress Syndrome * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Acute Respiratory Failure * 1  1/10 (10.00%)  2/165 (1.21%)  1/147 (0.68%) 
Bronchopneumopathy * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Bronchospasm * 1  0/10 (0.00%)  1/165 (0.61%)  1/147 (0.68%) 
Dyspnoea * 1  2/10 (20.00%)  1/165 (0.61%)  4/147 (2.72%) 
Epistaxis * 1  0/10 (0.00%)  2/165 (1.21%)  2/147 (1.36%) 
Hypoxia * 1  1/10 (10.00%)  0/165 (0.00%)  3/147 (2.04%) 
Lung Infiltration * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Oropharyngeal Pain * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Pleural Effusion * 1  0/10 (0.00%)  2/165 (1.21%)  0/147 (0.00%) 
Pneumonitis * 1  0/10 (0.00%)  2/165 (1.21%)  1/147 (0.68%) 
Pulmonary Embolism * 1  0/10 (0.00%)  1/165 (0.61%)  2/147 (1.36%) 
Pulmonary Hypertension * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Pulmonary Oedema * 1  0/10 (0.00%)  1/165 (0.61%)  2/147 (1.36%) 
Respiratory Failure * 1  0/10 (0.00%)  3/165 (1.82%)  3/147 (2.04%) 
Respiratory Tract Haemorrhage * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Pulmonary Haemorrhage * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
Wheezing * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatitis * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Hyperhidrosis * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Rash Vesicular * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Vascular disorders       
Deep Vein Thrombosis * 1  0/10 (0.00%)  1/165 (0.61%)  0/147 (0.00%) 
Hypertension * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Hypotension * 1  1/10 (10.00%)  0/165 (0.00%)  3/147 (2.04%) 
Orthostatic Hypotension * 1  0/10 (0.00%)  0/165 (0.00%)  2/147 (1.36%) 
Phlebitis * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Thrombosis * 1  0/10 (0.00%)  0/165 (0.00%)  1/147 (0.68%) 
Haemodynamic Instability * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
1
Term from vocabulary, MedDRA Version 20.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A: Decitabine + JNJ-56022473 Part B: Decitabine (Alone) Part B: Decitabine + JNJ-56022473
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/10 (90.00%)   157/165 (95.15%)   146/147 (99.32%) 
Blood and lymphatic system disorders       
Anaemia * 1  7/10 (70.00%)  80/165 (48.48%)  77/147 (52.38%) 
Febrile Neutropenia * 1  4/10 (40.00%)  22/165 (13.33%)  25/147 (17.01%) 
Leukocytosis * 1  0/10 (0.00%)  9/165 (5.45%)  1/147 (0.68%) 
Leukopenia * 1  1/10 (10.00%)  15/165 (9.09%)  12/147 (8.16%) 
Neutropenia * 1  1/10 (10.00%)  61/165 (36.97%)  64/147 (43.54%) 
Thrombocytopenia * 1  3/10 (30.00%)  86/165 (52.12%)  81/147 (55.10%) 
Splenomegaly * 1  1/10 (10.00%)  2/165 (1.21%)  2/147 (1.36%) 
Cardiac disorders       
Atrial Fibrillation * 1  0/10 (0.00%)  8/165 (4.85%)  13/147 (8.84%) 
Tachycardia * 1  1/10 (10.00%)  6/165 (3.64%)  14/147 (9.52%) 
Ear and labyrinth disorders       
Tympanic Membrane Disorder * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
Eye disorders       
Uveitis * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
Gastrointestinal disorders       
Abdominal Pain * 1  1/10 (10.00%)  12/165 (7.27%)  19/147 (12.93%) 
Abdominal Pain Upper * 1  2/10 (20.00%)  6/165 (3.64%)  9/147 (6.12%) 
Anal Incontinence * 1  0/10 (0.00%)  0/165 (0.00%)  10/147 (6.80%) 
Constipation * 1  3/10 (30.00%)  51/165 (30.91%)  47/147 (31.97%) 
Diarrhoea * 1  4/10 (40.00%)  41/165 (24.85%)  50/147 (34.01%) 
Dyspepsia * 1  1/10 (10.00%)  5/165 (3.03%)  10/147 (6.80%) 
Gingival Bleeding * 1  0/10 (0.00%)  10/165 (6.06%)  2/147 (1.36%) 
Haemorrhoids * 1  1/10 (10.00%)  8/165 (4.85%)  21/147 (14.29%) 
Nausea * 1  5/10 (50.00%)  33/165 (20.00%)  36/147 (24.49%) 
Stomatitis * 1  1/10 (10.00%)  16/165 (9.70%)  12/147 (8.16%) 
Toothache * 1  0/10 (0.00%)  9/165 (5.45%)  4/147 (2.72%) 
Vomiting * 1  5/10 (50.00%)  19/165 (11.52%)  26/147 (17.69%) 
Abdominal Discomfort * 1  1/10 (10.00%)  1/165 (0.61%)  6/147 (4.08%) 
Parotid Gland Enlargement * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
Upper Gastrointestinal Haemorrhage * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
General disorders       
Asthenia * 1  2/10 (20.00%)  25/165 (15.15%)  26/147 (17.69%) 
Chills * 1  3/10 (30.00%)  7/165 (4.24%)  30/147 (20.41%) 
Fatigue * 1  1/10 (10.00%)  31/165 (18.79%)  31/147 (21.09%) 
Oedema Peripheral * 1  5/10 (50.00%)  25/165 (15.15%)  46/147 (31.29%) 
Pain * 1  0/10 (0.00%)  5/165 (3.03%)  8/147 (5.44%) 
Pyrexia * 1  6/10 (60.00%)  46/165 (27.88%)  51/147 (34.69%) 
Gait Disturbance * 1  2/10 (20.00%)  0/165 (0.00%)  1/147 (0.68%) 
General Physical Health Deterioration * 1  1/10 (10.00%)  2/165 (1.21%)  1/147 (0.68%) 
Hepatobiliary disorders       
Hyperbilirubinaemia * 1  2/10 (20.00%)  7/165 (4.24%)  3/147 (2.04%) 
Infections and infestations       
Oral Candidiasis * 1  2/10 (20.00%)  6/165 (3.64%)  9/147 (6.12%) 
Oral Herpes * 1  3/10 (30.00%)  9/165 (5.45%)  11/147 (7.48%) 
Pneumonia * 1  1/10 (10.00%)  19/165 (11.52%)  19/147 (12.93%) 
Urinary Tract Infection * 1  0/10 (0.00%)  13/165 (7.88%)  13/147 (8.84%) 
Bronchitis * 1  1/10 (10.00%)  5/165 (3.03%)  5/147 (3.40%) 
Lung Infection * 1  1/10 (10.00%)  4/165 (2.42%)  2/147 (1.36%) 
Lymph Gland Infection * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
Oropharyngeal Candidiasis * 1  1/10 (10.00%)  0/165 (0.00%)  2/147 (1.36%) 
Respiratory Tract Infection * 1  1/10 (10.00%)  0/165 (0.00%)  3/147 (2.04%) 
Skin Infection * 1  1/10 (10.00%)  3/165 (1.82%)  2/147 (1.36%) 
Systemic Mycosis * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
Tooth Abscess * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
Upper Respiratory Tract Infection * 1  1/10 (10.00%)  6/165 (3.64%)  2/147 (1.36%) 
Injury, poisoning and procedural complications       
Contusion * 1  0/10 (0.00%)  5/165 (3.03%)  8/147 (5.44%) 
Fall * 1  0/10 (0.00%)  9/165 (5.45%)  13/147 (8.84%) 
Investigations       
Alanine Aminotransferase Increased * 1  0/10 (0.00%)  5/165 (3.03%)  9/147 (6.12%) 
Aspartate Aminotransferase Increased * 1  0/10 (0.00%)  5/165 (3.03%)  8/147 (5.44%) 
Blood Creatinine Increased * 1  0/10 (0.00%)  4/165 (2.42%)  8/147 (5.44%) 
Gamma-Glutamyltransferase Increased * 1  1/10 (10.00%)  1/165 (0.61%)  8/147 (5.44%) 
Weight Decreased * 1  0/10 (0.00%)  10/165 (6.06%)  16/147 (10.88%) 
Bacterial Test Positive * 1  1/10 (10.00%)  0/165 (0.00%)  1/147 (0.68%) 
Hepatic Enzyme Increased * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
International Normalised Ratio Increased * 1  1/10 (10.00%)  3/165 (1.82%)  4/147 (2.72%) 
Oxygen Saturation Decreased * 1  1/10 (10.00%)  0/165 (0.00%)  4/147 (2.72%) 
Metabolism and nutrition disorders       
Decreased Appetite * 1  4/10 (40.00%)  31/165 (18.79%)  25/147 (17.01%) 
Hyperglycaemia * 1  0/10 (0.00%)  4/165 (2.42%)  17/147 (11.56%) 
Hyperuricaemia * 1  0/10 (0.00%)  8/165 (4.85%)  9/147 (6.12%) 
Hypoalbuminaemia * 1  0/10 (0.00%)  5/165 (3.03%)  13/147 (8.84%) 
Hypocalcaemia * 1  1/10 (10.00%)  9/165 (5.45%)  14/147 (9.52%) 
Hypokalaemia * 1  3/10 (30.00%)  41/165 (24.85%)  53/147 (36.05%) 
Hypomagnesaemia * 1  2/10 (20.00%)  12/165 (7.27%)  20/147 (13.61%) 
Hypophosphataemia * 1  1/10 (10.00%)  5/165 (3.03%)  9/147 (6.12%) 
Fluid Overload * 1  1/10 (10.00%)  4/165 (2.42%)  6/147 (4.08%) 
Fluid Retention * 1  1/10 (10.00%)  4/165 (2.42%)  1/147 (0.68%) 
Hyperkalaemia * 1  1/10 (10.00%)  4/165 (2.42%)  5/147 (3.40%) 
Hypoglycaemia * 1  1/10 (10.00%)  2/165 (1.21%)  2/147 (1.36%) 
Hyponatraemia * 1  1/10 (10.00%)  7/165 (4.24%)  4/147 (2.72%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  1/10 (10.00%)  15/165 (9.09%)  12/147 (8.16%) 
Back Pain * 1  0/10 (0.00%)  18/165 (10.91%)  19/147 (12.93%) 
Pain in Extremity * 1  0/10 (0.00%)  12/165 (7.27%)  15/147 (10.20%) 
Muscle Spasms * 1  1/10 (10.00%)  4/165 (2.42%)  2/147 (1.36%) 
Muscular Weakness * 1  1/10 (10.00%)  4/165 (2.42%)  2/147 (1.36%) 
Musculoskeletal Chest Pain * 1  1/10 (10.00%)  4/165 (2.42%)  1/147 (0.68%) 
Myalgia * 1  1/10 (10.00%)  3/165 (1.82%)  4/147 (2.72%) 
Nervous system disorders       
Dizziness * 1  1/10 (10.00%)  9/165 (5.45%)  14/147 (9.52%) 
Headache * 1  1/10 (10.00%)  15/165 (9.09%)  16/147 (10.88%) 
Syncope * 1  2/10 (20.00%)  5/165 (3.03%)  6/147 (4.08%) 
Somnolence * 1  1/10 (10.00%)  2/165 (1.21%)  2/147 (1.36%) 
Psychiatric disorders       
Insomnia * 1  2/10 (20.00%)  13/165 (7.88%)  16/147 (10.88%) 
Adjustment Disorder with Depressed Mood * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
Agitation * 1  1/10 (10.00%)  3/165 (1.82%)  4/147 (2.72%) 
Depressed Mood * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
Hallucination * 1  1/10 (10.00%)  2/165 (1.21%)  1/147 (0.68%) 
Nervousness * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
Renal and urinary disorders       
Acute Kidney Injury * 1  0/10 (0.00%)  7/165 (4.24%)  11/147 (7.48%) 
Urinary Incontinence * 1  0/10 (0.00%)  5/165 (3.03%)  10/147 (6.80%) 
Renal Impairment * 1  1/10 (10.00%)  3/165 (1.82%)  5/147 (3.40%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  1/10 (10.00%)  15/165 (9.09%)  16/147 (10.88%) 
Dyspnoea * 1  3/10 (30.00%)  23/165 (13.94%)  22/147 (14.97%) 
Epistaxis * 1  1/10 (10.00%)  13/165 (7.88%)  20/147 (13.61%) 
Hypoxia * 1  1/10 (10.00%)  7/165 (4.24%)  8/147 (5.44%) 
Oropharyngeal Pain * 1  0/10 (0.00%)  7/165 (4.24%)  9/147 (6.12%) 
Pleural Effusion * 1  1/10 (10.00%)  10/165 (6.06%)  4/147 (2.72%) 
Bronchospasm * 1  3/10 (30.00%)  1/165 (0.61%)  6/147 (4.08%) 
Pharyngeal Oedema * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
Skin and subcutaneous tissue disorders       
Erythema * 1  0/10 (0.00%)  4/165 (2.42%)  9/147 (6.12%) 
Petechiae * 1  1/10 (10.00%)  10/165 (6.06%)  11/147 (7.48%) 
Pruritus * 1  1/10 (10.00%)  12/165 (7.27%)  11/147 (7.48%) 
Rash * 1  1/10 (10.00%)  11/165 (6.67%)  13/147 (8.84%) 
Hyperhidrosis * 1  1/10 (10.00%)  2/165 (1.21%)  7/147 (4.76%) 
Dry Skin * 1  1/10 (10.00%)  3/165 (1.82%)  2/147 (1.36%) 
Hidradenitis * 1  1/10 (10.00%)  0/165 (0.00%)  0/147 (0.00%) 
Purpura * 1  1/10 (10.00%)  1/165 (0.61%)  0/147 (0.00%) 
Skin Ulcer * 1  1/10 (10.00%)  2/165 (1.21%)  3/147 (2.04%) 
Vascular disorders       
Hypertension * 1  0/10 (0.00%)  13/165 (7.88%)  24/147 (16.33%) 
Hypotension * 1  1/10 (10.00%)  17/165 (10.30%)  22/147 (14.97%) 
1
Term from vocabulary, MedDRA Version 20.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Medical Director
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02472145    
Other Study ID Numbers: CR107273
56022473AML2002 ( Other Identifier: Janssen Research & Development, LLC )
2015-001611-12 ( EudraCT Number )
First Submitted: April 29, 2015
First Posted: June 15, 2015
Results First Submitted: January 24, 2019
Results First Posted: February 28, 2019
Last Update Posted: March 19, 2019