Trial Outcomes & Findings for 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 (NCT NCT02472145)
NCT ID: NCT02472145
Last Updated: 2019-03-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
326 participants
Primary outcome timeframe
Approximately up to 2.5 years
Results posted on
2019-03-19
Participant Flow
Participant milestones
| Measure |
Part A: Decitabine + JNJ-56022473
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.
|
Part B: Decitabine (Alone)
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.
|
Part B: Decitabine + JNJ-56022473
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 Study
STARTED
|
10
|
159
|
157
|
|
Overall Study
Treated
|
10
|
156
|
156
|
|
Overall Study
Safety
|
10
|
165
|
147
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
159
|
157
|
Reasons for withdrawal
| Measure |
Part A: Decitabine + JNJ-56022473
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.
|
Part B: Decitabine (Alone)
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.
|
Part B: Decitabine + JNJ-56022473
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 Study
Death
|
10
|
101
|
99
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
9
|
13
|
|
Overall Study
Sponsor decision
|
0
|
3
|
2
|
|
Overall Study
Other
|
0
|
45
|
43
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Part A: Decitabine + JNJ-56022473
n=10 Participants
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.
|
Part B: Decitabine (Alone)
n=159 Participants
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.
|
Part B: Decitabine + JNJ-56022473
n=157 Participants
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
n=326 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 10.88 • n=10 Participants
|
75 years
STANDARD_DEVIATION 5.6 • n=159 Participants
|
75.2 years
STANDARD_DEVIATION 5.32 • n=157 Participants
|
74.8 years
STANDARD_DEVIATION 5.91 • n=326 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
68 Participants
n=159 Participants
|
77 Participants
n=157 Participants
|
149 Participants
n=326 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
91 Participants
n=159 Participants
|
80 Participants
n=157 Participants
|
177 Participants
n=326 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
4 Participants
n=159 Participants
|
5 Participants
n=157 Participants
|
9 Participants
n=326 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=10 Participants
|
143 Participants
n=159 Participants
|
143 Participants
n=157 Participants
|
296 Participants
n=326 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
12 Participants
n=159 Participants
|
9 Participants
n=157 Participants
|
21 Participants
n=326 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants • 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.
|
0 Participants
n=158 Participants • 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.
|
0 Participants
n=157 Participants • 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.
|
0 Participants
n=325 Participants • 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 (NIH/OMB)
Asian
|
0 Participants
n=10 Participants • 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.
|
14 Participants
n=158 Participants • 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.
|
11 Participants
n=157 Participants • 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.
|
25 Participants
n=325 Participants • 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 (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants • 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.
|
0 Participants
n=158 Participants • 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.
|
0 Participants
n=157 Participants • 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.
|
0 Participants
n=325 Participants • 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 (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants • 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.
|
2 Participants
n=158 Participants • 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.
|
1 Participants
n=157 Participants • 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.
|
3 Participants
n=325 Participants • 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 (NIH/OMB)
White
|
10 Participants
n=10 Participants • 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.
|
133 Participants
n=158 Participants • 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.
|
141 Participants
n=157 Participants • 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.
|
284 Participants
n=325 Participants • 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 (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants • 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.
|
0 Participants
n=158 Participants • 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.
|
0 Participants
n=157 Participants • 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.
|
0 Participants
n=325 Participants • 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 (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants • 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.
|
9 Participants
n=158 Participants • 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.
|
4 Participants
n=157 Participants • 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.
|
13 Participants
n=325 Participants • 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
Asian
|
0 Participants
n=10 Participants
|
14 Participants
n=159 Participants
|
11 Participants
n=157 Participants
|
25 Participants
n=326 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=10 Participants
|
2 Participants
n=159 Participants
|
1 Participants
n=157 Participants
|
3 Participants
n=326 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=10 Participants
|
3 Participants
n=159 Participants
|
5 Participants
n=157 Participants
|
8 Participants
n=326 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=10 Participants
|
13 Participants
n=159 Participants
|
9 Participants
n=157 Participants
|
22 Participants
n=326 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
10 Participants
n=10 Participants
|
127 Participants
n=159 Participants
|
131 Participants
n=157 Participants
|
268 Participants
n=326 Participants
|
|
Region of Enrollment
Australia
|
0 Participants
n=10 Participants
|
10 Participants
n=159 Participants
|
18 Participants
n=157 Participants
|
28 Participants
n=326 Participants
|
|
Region of Enrollment
Belgium
|
3 Participants
n=10 Participants
|
11 Participants
n=159 Participants
|
6 Participants
n=157 Participants
|
20 Participants
n=326 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=10 Participants
|
6 Participants
n=159 Participants
|
2 Participants
n=157 Participants
|
8 Participants
n=326 Participants
|
|
Region of Enrollment
Germany
|
0 Participants
n=10 Participants
|
14 Participants
n=159 Participants
|
18 Participants
n=157 Participants
|
32 Participants
n=326 Participants
|
|
Region of Enrollment
Israel
|
0 Participants
n=10 Participants
|
18 Participants
n=159 Participants
|
11 Participants
n=157 Participants
|
29 Participants
n=326 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=10 Participants
|
12 Participants
n=159 Participants
|
11 Participants
n=157 Participants
|
23 Participants
n=326 Participants
|
|
Region of Enrollment
Poland
|
0 Participants
n=10 Participants
|
13 Participants
n=159 Participants
|
11 Participants
n=157 Participants
|
24 Participants
n=326 Participants
|
|
Region of Enrollment
Russia
|
0 Participants
n=10 Participants
|
30 Participants
n=159 Participants
|
26 Participants
n=157 Participants
|
56 Participants
n=326 Participants
|
|
Region of Enrollment
Spain
|
7 Participants
n=10 Participants
|
17 Participants
n=159 Participants
|
19 Participants
n=157 Participants
|
43 Participants
n=326 Participants
|
|
Region of Enrollment
Sweden
|
0 Participants
n=10 Participants
|
2 Participants
n=159 Participants
|
0 Participants
n=157 Participants
|
2 Participants
n=326 Participants
|
|
Region of Enrollment
Taiwan, Province Of China
|
0 Participants
n=10 Participants
|
8 Participants
n=159 Participants
|
4 Participants
n=157 Participants
|
12 Participants
n=326 Participants
|
|
Region of Enrollment
Turkey
|
0 Participants
n=10 Participants
|
2 Participants
n=159 Participants
|
5 Participants
n=157 Participants
|
7 Participants
n=326 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=10 Participants
|
1 Participants
n=159 Participants
|
3 Participants
n=157 Participants
|
4 Participants
n=326 Participants
|
|
Region of Enrollment
United States
|
0 Participants
n=10 Participants
|
10 Participants
n=159 Participants
|
16 Participants
n=157 Participants
|
26 Participants
n=326 Participants
|
|
Region of Enrollment
Korea, Republic Of
|
0 Participants
n=10 Participants
|
5 Participants
n=159 Participants
|
7 Participants
n=157 Participants
|
12 Participants
n=326 Participants
|
PRIMARY outcome
Timeframe: Approximately up to 2.5 yearsPopulation: Intent-to-Treat (ITT) population is defined as all randomized participants, grouped per treatment assigned by randomization, regardless of the actual treatment received.
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.
Outcome measures
| Measure |
Part B: Decitabine (Alone)
n=159 Participants
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.
|
Part B: Decitabine + JNJ-56022473
n=157 Participants
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.
|
|---|---|---|
|
Part B: Percentage of Participants Who Achieved Complete Response (Complete Response Rate) Based on Investigator Assessment
|
11.9 Percentage of participants
|
16.6 Percentage of participants
|
PRIMARY outcome
Timeframe: Approximately up to 2.5 yearsPopulation: ITT population is defined as all randomized participants, grouped per treatment assigned by randomization, regardless of the actual treatment received.
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.
Outcome measures
| Measure |
Part B: Decitabine (Alone)
n=159 Participants
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.
|
Part B: Decitabine + JNJ-56022473
n=157 Participants
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.
|
|---|---|---|
|
Part B: Overall Survival
|
7.26 Months
Interval 6.47 to 8.64
|
5.36 Months
Interval 4.27 to 7.95
|
SECONDARY outcome
Timeframe: Approximately up to 2.5 yearsPopulation: ITT population defined as all randomized participants, grouped per treatment assigned by randomization, regardless of actual treatment received.
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.
Outcome measures
| Measure |
Part B: Decitabine (Alone)
n=159 Participants
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.
|
Part B: Decitabine + JNJ-56022473
n=157 Participants
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.
|
|---|---|---|
|
Part B: Event-free Survival (EFS) Based on Investigator Assessment
|
6.24 Months
Interval 4.96 to 6.83
|
4.50 Months
Interval 3.61 to 6.74
|
SECONDARY outcome
Timeframe: Approximately up to 2.5 yearsPopulation: ITT population is defined as all randomized participants, grouped per treatment assigned by randomization, regardless of the actual treatment received.
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.
Outcome measures
| Measure |
Part B: Decitabine (Alone)
n=159 Participants
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.
|
Part B: Decitabine + JNJ-56022473
n=157 Participants
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.
|
|---|---|---|
|
Part B: Percentage of Participants Who Achieved CR and CRi (Overall Response Rate)
|
20.1 Percentage of Participants
|
26.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Approximately 2.5 yearsPopulation: Population included participants in ITT, among whom MRD negativity was evaluated upon achieving response.
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.
Outcome measures
| Measure |
Part B: Decitabine (Alone)
n=80 Participants
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.
|
Part B: Decitabine + JNJ-56022473
n=80 Participants
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.
|
|---|---|---|
|
Part B: Percentage of Participants With Complete Response (CR) Plus Minimal Residual Disease (MRD) Negative Complete Response With Incomplete Recovery (CRi)
|
13.8 Percentage of participants
|
21.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Approximately 2.5 yearsPopulation: Population included participants in ITT, who achieved CR or CRi.
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.
Outcome measures
| Measure |
Part B: Decitabine (Alone)
n=32 Participants
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.
|
Part B: Decitabine + JNJ-56022473
n=42 Participants
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.
|
|---|---|---|
|
Part B: Time to Best Response
|
16.71 Weeks
Interval 7.1 to 41.6
|
18.14 Weeks
Interval 7.3 to 68.4
|
SECONDARY outcome
Timeframe: Approximately 2.5 yearsPopulation: Population included participants in ITT, who achieved CR or CRi.
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.
Outcome measures
| Measure |
Part B: Decitabine (Alone)
n=32 Participants
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.
|
Part B: Decitabine + JNJ-56022473
n=42 Participants
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.
|
|---|---|---|
|
Part B: Duration of Response (DOR) Based on Investigator Assessment
|
23.71 Weeks
Interval 15.43 to
Upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of events.
|
NA Weeks
Interval 29.86 to
Median and upper limit of 95% CI was not estimable due to insufficient number of events.
|
Adverse Events
Part A: Decitabine + JNJ-56022473
Serious events: 9 serious events
Other events: 9 other events
Deaths: 10 deaths
Part B: Decitabine (Alone)
Serious events: 120 serious events
Other events: 157 other events
Deaths: 101 deaths
Part B: Decitabine + JNJ-56022473
Serious events: 126 serious events
Other events: 146 other events
Deaths: 99 deaths
Serious adverse events
| Measure |
Part A: Decitabine + JNJ-56022473
n=10 participants at risk
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.
|
Part B: Decitabine (Alone)
n=165 participants at risk
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.
|
Part B: Decitabine + JNJ-56022473
n=147 participants at risk
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.
|
|---|---|---|---|
|
Cardiac disorders
Cardiovascular Insufficiency
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
3.4%
5/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
3.4%
5/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Eye disorders
Diplopia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Blood and lymphatic system disorders
Febrile Bone Marrow Aplasia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
20.0%
2/10 • Throughout the study (Up to 2.5 years)
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.
|
21.8%
36/165 • Throughout the study (Up to 2.5 years)
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.
|
27.2%
40/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
3.0%
5/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Acute Abdomen
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
1.8%
3/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Diverticular Perforation
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Gastrointestinal Inflammation
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Gastrointestinal Angiodysplasia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Catheter Site Inflammation
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Gastrointestinal Polyp Haemorrhage
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Intestinal Haemorrhage
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Large Intestinal Obstruction
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Mechanical Ileus
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Asthenia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Anal Ulcer
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Bronchopulmonary Aspergillosis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Candida Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Catheter Site Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Clostridial Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Device Related Infection
|
20.0%
2/10 • Throughout the study (Up to 2.5 years)
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.
|
1.8%
3/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Device Related Sepsis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Enterobacter Bacteraemia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Escherichia Bacteraemia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Escherichia Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Escherichia Sepsis
|
20.0%
2/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Fungaemia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Gastroenteritis Rotavirus
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Gastrointestinal Candidiasis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Hepatic Infection Fungal
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Infected Skin Ulcer
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Infectious Colitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Klebsiella Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Liver Abscess
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Localised Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Lung Infection
|
40.0%
4/10 • Throughout the study (Up to 2.5 years)
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.
|
3.0%
5/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Meningitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Moraxella Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Neutropenic Sepsis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Parainfluenzae Virus Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Parotitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Periorbital Cellulitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Pneumocystis Jirovecii Pneumonia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
13.9%
23/165 • Throughout the study (Up to 2.5 years)
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.
|
16.3%
24/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Pneumonia Fungal
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Rhinovirus Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Pseudomembranous Colitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Pulmonary Mycosis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Pyelonephritis Chronic
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Rash Pustular
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
2.7%
4/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Sepsis
|
20.0%
2/10 • Throughout the study (Up to 2.5 years)
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.
|
3.6%
6/165 • Throughout the study (Up to 2.5 years)
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.
|
9.5%
14/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Septic Encephalopathy
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
5.4%
8/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Sinusitis Fungal
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Skin Infection
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Splenic Abscess
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Staphylococcal Infection
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
2.4%
4/165 • Throughout the study (Up to 2.5 years)
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.
|
4.1%
6/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Vulval Cellulitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
1.8%
3/165 • Throughout the study (Up to 2.5 years)
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.
|
2.7%
4/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Injury, poisoning and procedural complications
Transfusion Reaction
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Injury, poisoning and procedural complications
Transfusion-Related Acute Lung Injury
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Chest Pain
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Chills
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Death
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Fatigue
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
General Physical Health Deterioration
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
3.6%
6/165 • Throughout the study (Up to 2.5 years)
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.
|
2.7%
4/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Hyperthermia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Malaise
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
5.5%
9/165 • Throughout the study (Up to 2.5 years)
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.
|
6.1%
9/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
5.5%
9/165 • Throughout the study (Up to 2.5 years)
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.
|
10.2%
15/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Sudden Death
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
3.0%
5/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Hepatobiliary disorders
Cholangitis Acute
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Immune system disorders
Anaphylactic Shock
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Immune system disorders
Serum Sickness
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Actinomycotic Pulmonary Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Alveolar Osteitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Anal Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Aspergillus Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Bacterial Sepsis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis Pyrophosphate
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Quadriparesis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Seizure
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
2.7%
4/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Vascular Encephalopathy
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
2.7%
4/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Renal and urinary disorders
Calculus Urinary
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
2/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
2.7%
4/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
1.8%
3/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Haemorrhage
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Skin and subcutaneous tissue disorders
Rash Vesicular
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Condition Aggravated
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasm
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central Nervous System Leukaemia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chloroma
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Adenoma
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Gastric
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Vascular disorders
Haemodynamic Instability
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
3.6%
6/165 • Throughout the study (Up to 2.5 years)
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.
|
2.7%
4/147 • Throughout the study (Up to 2.5 years)
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.
|
Other adverse events
| Measure |
Part A: Decitabine + JNJ-56022473
n=10 participants at risk
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.
|
Part B: Decitabine (Alone)
n=165 participants at risk
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.
|
Part B: Decitabine + JNJ-56022473
n=147 participants at risk
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.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
70.0%
7/10 • Throughout the study (Up to 2.5 years)
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.
|
48.5%
80/165 • Throughout the study (Up to 2.5 years)
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.
|
52.4%
77/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
40.0%
4/10 • Throughout the study (Up to 2.5 years)
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.
|
13.3%
22/165 • Throughout the study (Up to 2.5 years)
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.
|
17.0%
25/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
5.5%
9/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
9.1%
15/165 • Throughout the study (Up to 2.5 years)
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.
|
8.2%
12/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
37.0%
61/165 • Throughout the study (Up to 2.5 years)
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.
|
43.5%
64/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
30.0%
3/10 • Throughout the study (Up to 2.5 years)
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.
|
52.1%
86/165 • Throughout the study (Up to 2.5 years)
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.
|
55.1%
81/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
4.8%
8/165 • Throughout the study (Up to 2.5 years)
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.
|
8.8%
13/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Cardiac disorders
Tachycardia
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
3.6%
6/165 • Throughout the study (Up to 2.5 years)
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.
|
9.5%
14/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
7.3%
12/165 • Throughout the study (Up to 2.5 years)
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.
|
12.9%
19/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
20.0%
2/10 • Throughout the study (Up to 2.5 years)
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.
|
3.6%
6/165 • Throughout the study (Up to 2.5 years)
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.
|
6.1%
9/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Anal Incontinence
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
6.8%
10/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Constipation
|
30.0%
3/10 • Throughout the study (Up to 2.5 years)
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.
|
30.9%
51/165 • Throughout the study (Up to 2.5 years)
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.
|
32.0%
47/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
4/10 • Throughout the study (Up to 2.5 years)
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.
|
24.8%
41/165 • Throughout the study (Up to 2.5 years)
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.
|
34.0%
50/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
3.0%
5/165 • Throughout the study (Up to 2.5 years)
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.
|
6.8%
10/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
6.1%
10/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Haemorrhoids
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
4.8%
8/165 • Throughout the study (Up to 2.5 years)
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.
|
14.3%
21/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • Throughout the study (Up to 2.5 years)
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.
|
20.0%
33/165 • Throughout the study (Up to 2.5 years)
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.
|
24.5%
36/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Stomatitis
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
9.7%
16/165 • Throughout the study (Up to 2.5 years)
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.
|
8.2%
12/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
5.5%
9/165 • Throughout the study (Up to 2.5 years)
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.
|
2.7%
4/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
5/10 • Throughout the study (Up to 2.5 years)
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.
|
11.5%
19/165 • Throughout the study (Up to 2.5 years)
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.
|
17.7%
26/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Asthenia
|
20.0%
2/10 • Throughout the study (Up to 2.5 years)
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.
|
15.2%
25/165 • Throughout the study (Up to 2.5 years)
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.
|
17.7%
26/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Chills
|
30.0%
3/10 • Throughout the study (Up to 2.5 years)
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.
|
4.2%
7/165 • Throughout the study (Up to 2.5 years)
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.
|
20.4%
30/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
18.8%
31/165 • Throughout the study (Up to 2.5 years)
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.
|
21.1%
31/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Oedema Peripheral
|
50.0%
5/10 • Throughout the study (Up to 2.5 years)
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.
|
15.2%
25/165 • Throughout the study (Up to 2.5 years)
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.
|
31.3%
46/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Pain
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
3.0%
5/165 • Throughout the study (Up to 2.5 years)
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.
|
5.4%
8/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Pyrexia
|
60.0%
6/10 • Throughout the study (Up to 2.5 years)
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.
|
27.9%
46/165 • Throughout the study (Up to 2.5 years)
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.
|
34.7%
51/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Oral Candidiasis
|
20.0%
2/10 • Throughout the study (Up to 2.5 years)
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.
|
3.6%
6/165 • Throughout the study (Up to 2.5 years)
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.
|
6.1%
9/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Oral Herpes
|
30.0%
3/10 • Throughout the study (Up to 2.5 years)
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.
|
5.5%
9/165 • Throughout the study (Up to 2.5 years)
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.
|
7.5%
11/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
11.5%
19/165 • Throughout the study (Up to 2.5 years)
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.
|
12.9%
19/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
7.9%
13/165 • Throughout the study (Up to 2.5 years)
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.
|
8.8%
13/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
3.0%
5/165 • Throughout the study (Up to 2.5 years)
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.
|
5.4%
8/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
5.5%
9/165 • Throughout the study (Up to 2.5 years)
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.
|
8.8%
13/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
3.0%
5/165 • Throughout the study (Up to 2.5 years)
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.
|
6.1%
9/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
3.0%
5/165 • Throughout the study (Up to 2.5 years)
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.
|
5.4%
8/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
2.4%
4/165 • Throughout the study (Up to 2.5 years)
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.
|
5.4%
8/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
5.4%
8/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Investigations
Weight Decreased
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
6.1%
10/165 • Throughout the study (Up to 2.5 years)
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.
|
10.9%
16/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
40.0%
4/10 • Throughout the study (Up to 2.5 years)
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.
|
18.8%
31/165 • Throughout the study (Up to 2.5 years)
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.
|
17.0%
25/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
2.4%
4/165 • Throughout the study (Up to 2.5 years)
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.
|
11.6%
17/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
4.8%
8/165 • Throughout the study (Up to 2.5 years)
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.
|
6.1%
9/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
3.0%
5/165 • Throughout the study (Up to 2.5 years)
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.
|
8.8%
13/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
5.5%
9/165 • Throughout the study (Up to 2.5 years)
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.
|
9.5%
14/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
30.0%
3/10 • Throughout the study (Up to 2.5 years)
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.
|
24.8%
41/165 • Throughout the study (Up to 2.5 years)
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.
|
36.1%
53/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
20.0%
2/10 • Throughout the study (Up to 2.5 years)
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.
|
7.3%
12/165 • Throughout the study (Up to 2.5 years)
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.
|
13.6%
20/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
3.0%
5/165 • Throughout the study (Up to 2.5 years)
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.
|
6.1%
9/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
9.1%
15/165 • Throughout the study (Up to 2.5 years)
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.
|
8.2%
12/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
10.9%
18/165 • Throughout the study (Up to 2.5 years)
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.
|
12.9%
19/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
7.3%
12/165 • Throughout the study (Up to 2.5 years)
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.
|
10.2%
15/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
5.5%
9/165 • Throughout the study (Up to 2.5 years)
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.
|
9.5%
14/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
9.1%
15/165 • Throughout the study (Up to 2.5 years)
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.
|
10.9%
16/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10 • Throughout the study (Up to 2.5 years)
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.
|
7.9%
13/165 • Throughout the study (Up to 2.5 years)
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.
|
10.9%
16/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
4.2%
7/165 • Throughout the study (Up to 2.5 years)
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.
|
7.5%
11/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
3.0%
5/165 • Throughout the study (Up to 2.5 years)
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.
|
6.8%
10/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
9.1%
15/165 • Throughout the study (Up to 2.5 years)
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.
|
10.9%
16/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
30.0%
3/10 • Throughout the study (Up to 2.5 years)
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.
|
13.9%
23/165 • Throughout the study (Up to 2.5 years)
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.
|
15.0%
22/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
7.9%
13/165 • Throughout the study (Up to 2.5 years)
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.
|
13.6%
20/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
4.2%
7/165 • Throughout the study (Up to 2.5 years)
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.
|
5.4%
8/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
4.2%
7/165 • Throughout the study (Up to 2.5 years)
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.
|
6.1%
9/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
6.1%
10/165 • Throughout the study (Up to 2.5 years)
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.
|
2.7%
4/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
2.4%
4/165 • Throughout the study (Up to 2.5 years)
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.
|
6.1%
9/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
6.1%
10/165 • Throughout the study (Up to 2.5 years)
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.
|
7.5%
11/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
7.3%
12/165 • Throughout the study (Up to 2.5 years)
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.
|
7.5%
11/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
6.7%
11/165 • Throughout the study (Up to 2.5 years)
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.
|
8.8%
13/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • Throughout the study (Up to 2.5 years)
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.
|
7.9%
13/165 • Throughout the study (Up to 2.5 years)
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.
|
16.3%
24/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
10.3%
17/165 • Throughout the study (Up to 2.5 years)
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.
|
15.0%
22/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Syncope
|
20.0%
2/10 • Throughout the study (Up to 2.5 years)
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.
|
3.0%
5/165 • Throughout the study (Up to 2.5 years)
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.
|
4.1%
6/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
30.0%
3/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
4.1%
6/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
4.8%
7/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Ear and labyrinth disorders
Tympanic Membrane Disorder
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Eye disorders
Uveitis
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
4.1%
6/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Parotid Gland Enlargement
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
Gait Disturbance
|
20.0%
2/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
General disorders
General Physical Health Deterioration
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
20.0%
2/10 • Throughout the study (Up to 2.5 years)
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.
|
4.2%
7/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Bronchitis
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
3.0%
5/165 • Throughout the study (Up to 2.5 years)
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.
|
3.4%
5/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Lung Infection
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
2.4%
4/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Lymph Gland Infection
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Oropharyngeal Candidiasis
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Respiratory Tract Infection
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Skin Infection
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
1.8%
3/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Systemic Mycosis
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Tooth Abscess
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
3.6%
6/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Investigations
Bacterial Test Positive
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Investigations
Hepatic Enzyme Increased
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Investigations
International Normalised Ratio Increased
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
1.8%
3/165 • Throughout the study (Up to 2.5 years)
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.
|
2.7%
4/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Investigations
Oxygen Saturation Decreased
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
2.7%
4/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
2.4%
4/165 • Throughout the study (Up to 2.5 years)
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.
|
4.1%
6/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Fluid Retention
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
2.4%
4/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
2.4%
4/165 • Throughout the study (Up to 2.5 years)
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.
|
3.4%
5/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
4.2%
7/165 • Throughout the study (Up to 2.5 years)
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.
|
2.7%
4/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
2.4%
4/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
2.4%
4/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
2.4%
4/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
1.8%
3/165 • Throughout the study (Up to 2.5 years)
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.
|
2.7%
4/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Nervous system disorders
Somnolence
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Psychiatric disorders
Adjustment Disorder with Depressed Mood
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Psychiatric disorders
Agitation
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
1.8%
3/165 • Throughout the study (Up to 2.5 years)
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.
|
2.7%
4/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Psychiatric disorders
Depressed Mood
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Psychiatric disorders
Hallucination
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
0.68%
1/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Psychiatric disorders
Nervousness
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Renal and urinary disorders
Renal Impairment
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
1.8%
3/165 • Throughout the study (Up to 2.5 years)
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.
|
3.4%
5/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Oedema
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
1.8%
3/165 • Throughout the study (Up to 2.5 years)
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.
|
1.4%
2/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
0.61%
1/165 • Throughout the study (Up to 2.5 years)
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.
|
0.00%
0/147 • Throughout the study (Up to 2.5 years)
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.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
10.0%
1/10 • Throughout the study (Up to 2.5 years)
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.
|
1.2%
2/165 • Throughout the study (Up to 2.5 years)
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.
|
2.0%
3/147 • Throughout the study (Up to 2.5 years)
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.
|
Additional Information
Senior Medical Director
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER