Trial Outcomes & Findings for An Efficacy and Safety Study of Decitabine in Participants With Myelodysplastic Syndrome (MDS) (NCT NCT00744757)
NCT ID: NCT00744757
Last Updated: 2013-09-09
Results Overview
Percentage of participants with response: complete response (CR) or partial response (PR) according to International Working Group (IWG) 2006 criteria was evaluated. CR in bone marrow is defined as\<=to 5% myeloblasts with normal maturation of all cell lines and persistent dysplasia was noted in peripheral blood hemoglobin \>=11 gram (g) per deciliter (dl), platelets \>=100\*10\^9 liter (l), neutrophils \>=1.0\*10\^9 l, Blasts 0%. Partial response is defined as all CR criteria if abnormal before treatment except: bone marrow blasts decreased by \>=50% over pre-treatment but still \>=5%.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)
Results posted on
2013-09-09
Participant Flow
Participant milestones
| Measure |
Decitabine
Decitabine 20 milligram per square meter (mg per m\^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
Decitabine
Decitabine 20 milligram per square meter (mg per m\^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Objective disease progression
|
7
|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
6
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
An Efficacy and Safety Study of Decitabine in Participants With Myelodysplastic Syndrome (MDS)
Baseline characteristics by cohort
| Measure |
Decitabine
n=37 Participants
Decitabine 20 milligram per square meter (mg per m\^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Age Continuous
|
68.0 Years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)Population: The efficacy-evaluable (EE) population included all participants who received at least 2 cycles of treatment. Participants who died before receiving 2 complete cycles or were taken off study due to progressive disease were included. Here 'N' specifies those participants who were evaluable for this outcome measure.
Percentage of participants with response: complete response (CR) or partial response (PR) according to International Working Group (IWG) 2006 criteria was evaluated. CR in bone marrow is defined as\<=to 5% myeloblasts with normal maturation of all cell lines and persistent dysplasia was noted in peripheral blood hemoglobin \>=11 gram (g) per deciliter (dl), platelets \>=100\*10\^9 liter (l), neutrophils \>=1.0\*10\^9 l, Blasts 0%. Partial response is defined as all CR criteria if abnormal before treatment except: bone marrow blasts decreased by \>=50% over pre-treatment but still \>=5%.
Outcome measures
| Measure |
Decitabine
n=34 Participants
Decitabine 20 milligram per square meter (mg per m\^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Response
|
23.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7 and 8, each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)Population: Intent-to-treat (ITT) population was defined as all participants who had received at least one dose of treatment. Here 'N' specifies those participants who were evaluable for this outcome measure and 'n' specifies those participants who were evaluable for this outcome measure at given time point.
Hematologic treatment response was assessed as per IWG 2006 criteria. This is measured in erythroid(HI-E), platelet(HI-P) and neutrophil(HI-N) lineages. HI-E response(pre-treatment\<11 gram per deciliter \[g/dl\]):hemoglobin increase by\>=1.5 g/dl and relevant reduction in RBC transfusions by 4 RBC transfusions/8week. HI-P response (pre-treatment\<100\*109/l):absolute increase of \>=30\*10\^9/l for participants starting with\>20\*10\^9/l and increase from \<20\*10\^9/l to\>20\*10\^9/l and by at least 100%. HI-N response (pre-treatment\<1.0\*10\^9/l): at least 100% increase and an absolute increase \>0.5\*10\^9/l.
Outcome measures
| Measure |
Decitabine
n=34 Participants
Decitabine 20 milligram per square meter (mg per m\^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Hematologic Treatment Response
End of treatment: HI-P
|
34.5 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 8: HI-P
|
56.3 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 8: HI-N
|
12.5 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
End of treatment: HI-E
|
27.6 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
End of treatment: HI-N
|
6.9 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 1: HI-P
|
8.8 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 1: HI-N
|
2.9 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 2: HI-E
|
17.2 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 2: HI-P
|
27.6 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 2: HI-N
|
6.9 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 3: HI-E
|
28.6 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 3: HI-P
|
39.3 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 3: HI-N
|
17.9 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 1: HI-E
|
5.9 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 4: HI-E
|
37.0 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 4: HI-P
|
33.3 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 4: HI-N
|
7.4 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 5: HI-E
|
40.9 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 5: HI-P
|
40.9 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 5: HI-N
|
13.6 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 6: HI-E
|
52.4 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 6: HI-P
|
61.9 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 6: HI-N
|
19.1 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 7: HI-E
|
47.1 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 7: HI-P
|
52.9 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 7: HI-N
|
5.9 Percentage of participants
|
|
Percentage of Participants With Hematologic Treatment Response
Cycle 8: HI-E
|
43.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)Population: ITT population was defined as all participants who had received at least one dose of treatment. Here 'N' specifies those participants who were evaluated for this outcome measure and 'n' specifies those participants who were evaluated at given time point.
Cytogenetic responses was assessed as per IWG 2006 criteria which define complete response as disappearance of the chromosomal abnormality without appearance of new ones and partial response as at least 50 percent reduction of the chromosomal abnormality.
Outcome measures
| Measure |
Decitabine
n=20 Participants
Decitabine 20 milligram per square meter (mg per m\^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Cytogenetic Response
End of treatment, Complete Response (n=17)
|
11.8 Percentage of participants
|
|
Percentage of Participants With Cytogenetic Response
End of treatment, Partial Response (n=17)
|
5.9 Percentage of participants
|
|
Percentage of Participants With Cytogenetic Response
Cycle 2, Complete Response (n=18)
|
22.2 Percentage of participants
|
|
Percentage of Participants With Cytogenetic Response
Cycle 2, Partial Response (n=18)
|
0.0 Percentage of participants
|
|
Percentage of Participants With Cytogenetic Response
Cycle 4, Complete Response (n=20)
|
20.0 Percentage of participants
|
|
Percentage of Participants With Cytogenetic Response
Cycle 4, Partial Response (n=20)
|
25.0 Percentage of participants
|
|
Percentage of Participants With Cytogenetic Response
Cycle 6, Complete Response (n=11)
|
18.2 Percentage of participants
|
|
Percentage of Participants With Cytogenetic Response
Cycle 6, Partial Response (n=11)
|
27.3 Percentage of participants
|
|
Percentage of Participants With Cytogenetic Response
Cycle 8, Complete Response (n=6)
|
0.0 Percentage of participants
|
|
Percentage of Participants With Cytogenetic Response
Cycle 8, Partial Response (n=6)
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Start of treatment until disease progression or death (whichever occur first) or up to 736 daysPopulation: ITT population was defined as all participants who had received at least 1 dose of study medication.
Time to AML is defined as greater than 30 percent of blasts in bone marrow or the time to death was calculated from the date of treatment start until disease progression to AML or until death, which ever occurred first. Participants who were still alive and did not progress to AML were censored at the moment of last visit.
Outcome measures
| Measure |
Decitabine
n=37 Participants
Decitabine 20 milligram per square meter (mg per m\^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Time to Acute Myeloid Leukemia (AML) Progression or Death
|
22.8 Months
Interval 0.3 to 25.4
|
SECONDARY outcome
Timeframe: Start of treatment until disease progression or death (whichever occur first) or up to 736 daysPopulation: ITT population was defined as all participants who had received at least 1 dose of study medication.
Overall survival was defined as the time from the date of treatment start until death (whatever the cause). It was calculated from Kaplan-Meier estimates. Participants still alive were censored at the moment of last visit or contact.
Outcome measures
| Measure |
Decitabine
n=37 Participants
Decitabine 20 milligram per square meter (mg per m\^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
22.8 Months
Interval 0.3 to 25.4
|
SECONDARY outcome
Timeframe: 8 weeks before first dose until disease progression or death (whichever occur first) or up to 736 daysPopulation: ITT population was defined as all participants who had received at least 1 dose of study medication.
Transfusion requirements for both red blood cells as well as platelets were recorded for each participant.
Outcome measures
| Measure |
Decitabine
n=37 Participants
Decitabine 20 milligram per square meter (mg per m\^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Transfusion Dependency
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: 8 weeks before first dose and 736 days of treatmentPopulation: ITT population was defined as all participants who had received at least 1 dose of study medication.
Transfusion independent participants were calculated from all the participants who required transfusion in the duration of 8 weeks before first dose until disease progression or death or up to 736 days. Transfusion independence was defined as lack of requirement for transfusions for at least 8 weeks.
Outcome measures
| Measure |
Decitabine
n=37 Participants
Decitabine 20 milligram per square meter (mg per m\^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Transfusion Independency
|
27 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 up to Cycle 8, each cycle of 28 days.Population: ITT population was defined as all participants who had received at least one dose of treatment. Here 'n' specifies those participants who were evaluated for this outcome measure at given time point.
Duration of hospitalization was calculated for each participant, using the sum of all hospital days by subtracting the date of discharge from the date of admission.
Outcome measures
| Measure |
Decitabine
n=37 Participants
Decitabine 20 milligram per square meter (mg per m\^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Duration for Hospitalization
Cycle 1 (n=37)
|
9.0 Days
Standard Deviation 9.4
|
|
Duration for Hospitalization
Cycle 2 (n=30)
|
15.4 Days
Standard Deviation 16.2
|
|
Duration for Hospitalization
Cycle 3 (n=28)
|
13.3 Days
Standard Deviation 11.5
|
|
Duration for Hospitalization
Cycle 4 (n=28)
|
27.1 Days
Standard Deviation 52.9
|
|
Duration for Hospitalization
Cycle 5 (n=22)
|
22.5 Days
Standard Deviation 38.6
|
|
Duration for Hospitalization
Cycle 6 (n=21)
|
7.5 Days
Standard Deviation 5.0
|
|
Duration for Hospitalization
Cycle 7 (n=17)
|
33.3 Days
Standard Deviation 56.5
|
|
Duration for Hospitalization
Cycle 8 (n=16)
|
5.0 Days
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Start of treatment until disease progression or death or up to Cycle 8, each cycle of 28 daysPopulation: ITT population was defined as all participants who had received at least 1 dose of study medication.
The events (reasons) for hospitalizations such as infection, transfusion, acute choleycystitis, allergic transfusion reaction, dyspnoea with right pleural effusion, febrile neutropenia, fever, for decitabine, Myelodysplastic Syndrome (MDS) hematuria, paronychia, pneumonia, heart failure, peri-anal abscess (PAA), pancytopenia,fluctuated neutropenia fever, right dorsal foot cellulitis, Right lower (Rt.Lw) lung pneumonia with impending respiratory (resp) failure, Serious adverse event (SAE)+schedule hospitalization for decitabine, septic shock and not available were reported.
Outcome measures
| Measure |
Decitabine
n=37 Participants
Decitabine 20 milligram per square meter (mg per m\^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Events Which Led to Hospitalization
Dyspnoea with right pleural effusion
|
4 Events
|
|
Number of Events Which Led to Hospitalization
Right dorsal foot cellulitis
|
1 Events
|
|
Number of Events Which Led to Hospitalization
Fever
|
4 Events
|
|
Number of Events Which Led to Hospitalization
For Decitabine
|
33 Events
|
|
Number of Events Which Led to Hospitalization
MDS hematuria
|
2 Events
|
|
Number of Events Which Led to Hospitalization
Paronychia, pneumonia, heart failure
|
1 Events
|
|
Number of Events Which Led to Hospitalization
PAA,pancytopenia,fluctuated neutropenia fever
|
1 Events
|
|
Number of Events Which Led to Hospitalization
Rt Lw lung pneumonia with impending resp. failure
|
1 Events
|
|
Number of Events Which Led to Hospitalization
SAE+Schedule hospitalization for Decitabine
|
4 Events
|
|
Number of Events Which Led to Hospitalization
Septic shock
|
1 Events
|
|
Number of Events Which Led to Hospitalization
Not available
|
36 Events
|
|
Number of Events Which Led to Hospitalization
Infection
|
10 Events
|
|
Number of Events Which Led to Hospitalization
Transfusion
|
4 Events
|
|
Number of Events Which Led to Hospitalization
Acute choleycystitis
|
1 Events
|
|
Number of Events Which Led to Hospitalization
Allergic transfusion reaction
|
1 Events
|
|
Number of Events Which Led to Hospitalization
Febrile neutropenia
|
16 Events
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1 and Cycle 8 (each cycle of 28 days)Population: ITT population was defined as all participants who had received at least 1 dose of study medication.
The quality of life was assessed by the questionnaire QLQ C-30 designed by European Organization for the Research and Treatment of Cancer (EORTC). EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Most questions used 4-point scale (1=Not at All' to 4=Very Much') and 2 questions: Q29 on overall health and Q30 on overall quality of life uses 7-point scale ranging from 1=Very Poor to 7=Excellent. Higher score indicates better quality of life.
Outcome measures
| Measure |
Decitabine
n=37 Participants
Decitabine 20 milligram per square meter (mg per m\^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Quality of Life Assessment
Baseline, Q29
|
4.4 Unit on a scale
Standard Deviation 1.5
|
|
Quality of Life Assessment
Baseline, Q30
|
4.9 Unit on a scale
Standard Deviation 1.3
|
|
Quality of Life Assessment
End of treatment, Q29
|
4.3 Unit on a scale
Standard Deviation 1.7
|
|
Quality of Life Assessment
End of treatment, Q30
|
4.5 Unit on a scale
Standard Deviation 1.8
|
Adverse Events
Decitabine
Serious events: 28 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Decitabine
n=37 participants at risk
Decitabine 20 milligram per square meter (mg per m\^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
51.4%
19/37 • Baseline up to 30 days after last medication
|
|
Blood and lymphatic system disorders
Anaemia
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Blood and lymphatic system disorders
Pancytopenia
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Cardiac disorders
Cardiac failure
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Cardiac disorders
Cardiac failure congestive
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Cardiac disorders
Cardiac valve vegetation
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Anal fistula
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Constipation
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Ileus
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
General disorders
Pyrexia
|
13.5%
5/37 • Baseline up to 30 days after last medication
|
|
General disorders
Multi-organ failure
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
General disorders
Induration
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Hepatobiliary disorders
Hepatitis acute
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Immune system disorders
Anaphylactic shock
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Pneumonia
|
18.9%
7/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Septic shock
|
10.8%
4/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Anal abscess
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Cellulitis
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Pneumonia fungal
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Bronchopneumonia
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Escherichia bacterial
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Escherichia bacteraemia
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Escherichia infection
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Fungaemia
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Hepatic infection
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Liver abscess
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Paronychia
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Pneumonia klebsiella
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Splenic abscess
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Splenic infection
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Urinary tract infection
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Renal and urinary disorders
Renal failure acute
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Renal and urinary disorders
Urinary retention
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
|
Vascular disorders
Deep vein thrombosis
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Vascular disorders
Shock
|
2.7%
1/37 • Baseline up to 30 days after last medication
|
Other adverse events
| Measure |
Decitabine
n=37 participants at risk
Decitabine 20 milligram per square meter (mg per m\^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Leucopenia
|
75.7%
28/37 • Baseline up to 30 days after last medication
|
|
Blood and lymphatic system disorders
Anaemia
|
62.2%
23/37 • Baseline up to 30 days after last medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
59.5%
22/37 • Baseline up to 30 days after last medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
54.1%
20/37 • Baseline up to 30 days after last medication
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Blood and lymphatic system disorders
Lymphopenia
|
18.9%
7/37 • Baseline up to 30 days after last medication
|
|
Blood and lymphatic system disorders
White blood cell disorder
|
13.5%
5/37 • Baseline up to 30 days after last medication
|
|
Blood and lymphatic system disorders
Pancytopenia
|
10.8%
4/37 • Baseline up to 30 days after last medication
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Blood and lymphatic system disorders
Platelet disorder
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Blood and lymphatic system disorders
Splenomegaly
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Cardiac disorders
Cardiomegaly
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Cardiac disorders
Palpitations
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Cardiac disorders
Bradycardia
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Ear and labyrinth disorders
Ear pain
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Ear and labyrinth disorders
Tinnitus
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Eye disorders
Conjunctival haemorrhage
|
10.8%
4/37 • Baseline up to 30 days after last medication
|
|
Eye disorders
Conjunctivitis
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Nausea
|
37.8%
14/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Constipation
|
29.7%
11/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Diarrhoea
|
32.4%
12/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Mouth ulceration
|
32.4%
12/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Vomiting
|
27.0%
10/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Abdominal distension
|
21.6%
8/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Gingival bleeding
|
18.9%
7/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Abdominal pain
|
16.2%
6/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Haemorrhoids
|
16.2%
6/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
13.5%
5/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
13.5%
5/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Melaena
|
10.8%
4/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Gingival pain
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Haematochezia
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Stomatitis
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Dysgeusia
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Dyspepsia
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Gingivitis
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
General disorders
Pyrexia
|
35.1%
13/37 • Baseline up to 30 days after last medication
|
|
General disorders
Fatigue
|
35.1%
13/37 • Baseline up to 30 days after last medication
|
|
General disorders
Malaise
|
35.1%
13/37 • Baseline up to 30 days after last medication
|
|
General disorders
Oedema peripheral
|
35.1%
13/37 • Baseline up to 30 days after last medication
|
|
General disorders
Asthenia
|
13.5%
5/37 • Baseline up to 30 days after last medication
|
|
General disorders
Chest discomfort
|
10.8%
4/37 • Baseline up to 30 days after last medication
|
|
General disorders
Chest pain
|
10.8%
4/37 • Baseline up to 30 days after last medication
|
|
General disorders
Oedema
|
10.8%
4/37 • Baseline up to 30 days after last medication
|
|
General disorders
Chills
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
General disorders
Pain
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
General disorders
Hyperhidrosis
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
General disorders
Ulcer
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Hepatobiliary disorders
Hepatic cyst
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Hepatobiliary disorders
Jaundice
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Immune system disorders
Hypersensitivity
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Pneumonia
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Upper respiratory tract infection
|
21.6%
8/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Cellulitis
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Septic shock
|
13.5%
5/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Herpes simplex
|
10.8%
4/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Urinary tract infection
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Oral Candidiasis
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Paronychia
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Sepsis
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Tinea pedis
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Infections and infestations
Onychomycosis
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
18.9%
7/37 • Baseline up to 30 days after last medication
|
|
Injury, poisoning and procedural complications
Wound complication
|
10.8%
4/37 • Baseline up to 30 days after last medication
|
|
Injury, poisoning and procedural complications
Contusion
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Investigations
Weight decreased
|
16.2%
6/37 • Baseline up to 30 days after last medication
|
|
Investigations
Alanine aminotransferase increased
|
13.5%
5/37 • Baseline up to 30 days after last medication
|
|
Investigations
Aspartate aminotransferase increased
|
10.8%
4/37 • Baseline up to 30 days after last medication
|
|
Investigations
Haemoglobin
|
10.8%
4/37 • Baseline up to 30 days after last medication
|
|
Investigations
Monocyte count decreased
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Investigations
Basophil count increased
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Investigations
Blood alkaline phosphatase increased
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Investigations
Blood creatinine increased
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Investigations
Cardiac murmur
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Investigations
Eosinophil count increased
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Investigations
Lymphocyte count increased
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Investigations
Neutrophil count
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Investigations
Urine output decrease
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Investigations
Weight increased
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.8%
14/37 • Baseline up to 30 days after last medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
27.0%
10/37 • Baseline up to 30 days after last medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
18.9%
7/37 • Baseline up to 30 days after last medication
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.2%
6/37 • Baseline up to 30 days after last medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
13.5%
5/37 • Baseline up to 30 days after last medication
|
|
Metabolism and nutrition disorders
Hyperbilirubinaemia
|
10.8%
4/37 • Baseline up to 30 days after last medication
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Metabolism and nutrition disorders
Increased appetite
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
27.0%
10/37 • Baseline up to 30 days after last medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.2%
6/37 • Baseline up to 30 days after last medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.5%
5/37 • Baseline up to 30 days after last medication
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
10.8%
4/37 • Baseline up to 30 days after last medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.8%
4/37 • Baseline up to 30 days after last medication
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Nervous system disorders
Dizziness
|
37.8%
14/37 • Baseline up to 30 days after last medication
|
|
Nervous system disorders
Headache
|
18.9%
7/37 • Baseline up to 30 days after last medication
|
|
Nervous system disorders
Hypoaesthesia
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Nervous system disorders
Poor quality sleep
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Nervous system disorders
Vertigo
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Psychiatric disorders
Insomnia
|
21.6%
8/37 • Baseline up to 30 days after last medication
|
|
Psychiatric disorders
Anxiety
|
13.5%
5/37 • Baseline up to 30 days after last medication
|
|
Psychiatric disorders
Depressed mood
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Renal and urinary disorders
Renal failure acute
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Renal and urinary disorders
Dysuria
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.8%
14/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
24.3%
9/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
24.3%
9/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.2%
6/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
13.5%
5/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
10.8%
4/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.8%
4/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute tonsillitis
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
29.7%
11/37 • Baseline up to 30 days after last medication
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
13.5%
5/37 • Baseline up to 30 days after last medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.2%
6/37 • Baseline up to 30 days after last medication
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Vascular disorders
Petechiae
|
13.5%
5/37 • Baseline up to 30 days after last medication
|
|
Vascular disorders
Haematoma
|
8.1%
3/37 • Baseline up to 30 days after last medication
|
|
Vascular disorders
Hypertension
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Vascular disorders
Hypotension
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
|
Gastrointestinal disorders
Periodontitis
|
5.4%
2/37 • Baseline up to 30 days after last medication
|
Additional Information
Medical Director
Medical Affairs, Janssen Taiwan
Phone: +886-2-23761255
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60