Trial Outcomes & Findings for An Effectiveness and Safety Study of Decitabine in Patients With Myelodysplastic Syndrome (NCT NCT01751867)
NCT ID: NCT01751867
Last Updated: 2016-04-05
Results Overview
IWG 2006 response criteria - CR: bone marrow evaluation shows less than or equal to (\<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin \>= 11 gram per deciliter (g/dL), neutrophils \>= 1000/mL, platelets \>= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by \>=50%, still greater than 5% in bone marrow.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
135 participants
Primary outcome timeframe
From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation
Results posted on
2016-04-05
Participant Flow
This study was conducted across 12 centers in China.
Participant milestones
| Measure |
3-Day Posology
Decitabine 15 milligram per meter\^2 (mg/m\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
|
5-Day Posology
Decitabine 20 mg/m\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
99
|
|
Overall Study
Treated
|
34
|
98
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
36
|
99
|
Reasons for withdrawal
| Measure |
3-Day Posology
Decitabine 15 milligram per meter\^2 (mg/m\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
|
5-Day Posology
Decitabine 20 mg/m\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
|
|---|---|---|
|
Overall Study
Completed treatment,dropped in follow-up
|
4
|
8
|
|
Overall Study
Diease Progression
|
4
|
18
|
|
Overall Study
Adverse Event
|
8
|
15
|
|
Overall Study
Poor Compliance
|
0
|
5
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Physician Decision
|
4
|
7
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Death
|
0
|
5
|
|
Overall Study
Other
|
11
|
37
|
|
Overall Study
Randomized but not treated.
|
2
|
1
|
Baseline Characteristics
An Effectiveness and Safety Study of Decitabine in Patients With Myelodysplastic Syndrome
Baseline characteristics by cohort
| Measure |
3-Day Posology
n=36 Participants
Decitabine 15 milligram per meter\^2 (mg/m\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
|
5-Day Posology
n=99 Participants
Decitabine 20 mg/m\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.2 Years
STANDARD_DEVIATION 16.04 • n=5 Participants
|
51.6 Years
STANDARD_DEVIATION 14.78 • n=7 Participants
|
51.0 Years
STANDARD_DEVIATION 15.11 • n=5 Participants
|
|
Age, Customized
18-60 Years (Y) (including 18 Y, excluding 60 Y)
|
25 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Age, Customized
Greater than or equal to (>=) 60 Y
|
11 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuationPopulation: Intent-to-treat (ITT) population: Participants who received at least one dose of study medication.
IWG 2006 response criteria - CR: bone marrow evaluation shows less than or equal to (\<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin \>= 11 gram per deciliter (g/dL), neutrophils \>= 1000/mL, platelets \>= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by \>=50%, still greater than 5% in bone marrow.
Outcome measures
| Measure |
3-Day Posology
n=34 Participants
Decitabine 15 milligram per meter\^2 (mg/m\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
|
5-Day Posology
n=98 Participants
Decitabine 20 mg/m\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
|
|---|---|---|
|
Overall Response Rate (ORR): Number of Participants Who Achieved Either Complete Remission (CR), Partial Remission (PR), or Marrow Complete Remission (mCR) - International Working Group (IWG) 2006 Response Criteria
|
10 Participants
Interval 12.9 to 44.4
|
25 Participants
Interval 13.9 to 31.2
|
SECONDARY outcome
Timeframe: From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuationPopulation: Intent-to-treat (ITT) population- Participants who received at least one dose of study drug.
IWG 2006 response criteria - CR: bone marrow evaluation shows \<= 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin \>= 11 g/dL, neutrophils \>= 1000/mL, platelets \>= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by \>= 50%, still greater than 5% in bone marrow; HI: hemoglobin increase of \>= 1.5 g/dL, platelet increase of \>= 30,000/mL (starting with \> 20,000/mL), neutrophils increase of \>= 100% and \> 500/μL.
Outcome measures
| Measure |
3-Day Posology
n=34 Participants
Decitabine 15 milligram per meter\^2 (mg/m\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
|
5-Day Posology
n=98 Participants
Decitabine 20 mg/m\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
|
|---|---|---|
|
Hematological Improvement Rate: Number of Participants Who Achieved Complete Remission (CR), Partial Remission (PR) and Hematologic Improvement (HI) - International Working Group (IWG) 2006 Response Criteria
|
16 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuationPopulation: Participants who had baseline cytogenetic abnormality and had at least one post baseline cytogenetic assessments during study.
As per IWG 2006 response criteria - Complete cytogenetic response: disappearance of the chromosomal abnormality without appearance of new ones; Partial cytogenetic response: At least 50% reduction of the chromosomal abnormality. Status of Clinical response - complete remission (CR); marrow CR (mCR); partial remission (PR).
Outcome measures
| Measure |
3-Day Posology
n=6 Participants
Decitabine 15 milligram per meter\^2 (mg/m\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
|
5-Day Posology
n=24 Participants
Decitabine 20 mg/m\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
|
|---|---|---|
|
Cytogenetic Response Rate: Percentage of Participants Who Achieved Cytogenetic Response (Complete+Partial) by Status of Clinical Overall Response - International Working Group (IWG) 2006 Response Criteria
Overall (n=6, 24)
|
66.7 Percentage of Participants
|
66.7 Percentage of Participants
|
|
Cytogenetic Response Rate: Percentage of Participants Who Achieved Cytogenetic Response (Complete+Partial) by Status of Clinical Overall Response - International Working Group (IWG) 2006 Response Criteria
CR+mCR+PR (n=3, 13)
|
100.0 Percentage of Participants
|
84.6 Percentage of Participants
|
|
Cytogenetic Response Rate: Percentage of Participants Who Achieved Cytogenetic Response (Complete+Partial) by Status of Clinical Overall Response - International Working Group (IWG) 2006 Response Criteria
CR (n=2, 3)
|
100.0 Percentage of Participants
|
66.7 Percentage of Participants
|
|
Cytogenetic Response Rate: Percentage of Participants Who Achieved Cytogenetic Response (Complete+Partial) by Status of Clinical Overall Response - International Working Group (IWG) 2006 Response Criteria
mCR (n=1, 10)
|
100.0 Percentage of Participants
|
90.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline; up to 2 yearsPopulation: Intent-to-treat (ITT) population: Participants who received at least one dose of study drug. Here, 'n' is the number of participants analyzed at specified time point.
A participant was considered to be transfusion independent, if the participant had no transfusions of Red Blood Cells (RBCs) or platelets for 8 consecutive weeks or more.
Outcome measures
| Measure |
3-Day Posology
n=34 Participants
Decitabine 15 milligram per meter\^2 (mg/m\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
|
5-Day Posology
n=98 Participants
Decitabine 20 mg/m\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
|
|---|---|---|
|
Transfusion Independence: Number of Participants Who Were Transfusion Independent
Baseline (Before First Dose) (n=34, 98)
|
7 Participants
|
37 Participants
|
|
Transfusion Independence: Number of Participants Who Were Transfusion Independent
Treatment Phase (n=34, 97)
|
18 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Intent-to-treat (ITT) population: Participants who received at least one dose of study drug.
Duration of hospitalization was calculated as, total number of days a participant stayed in hospital during study treatment divided by the study treatment duration
Outcome measures
| Measure |
3-Day Posology
n=34 Participants
Decitabine 15 milligram per meter\^2 (mg/m\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
|
5-Day Posology
n=98 Participants
Decitabine 20 mg/m\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
|
|---|---|---|
|
Mean Percentage of Duration of Hospitalization (Relative to Days on Study Treatment)
|
59.6 Percentage of total days
Standard Deviation 34.20
|
59.2 Percentage of total days
Standard Deviation 34.17
|
SECONDARY outcome
Timeframe: From the date of dosing until death or lost to follow-up for up to 2.5 years after last patient was enrolledPopulation: Intent-to-treat (ITT) population- Participants who received at least one dose of study drug.
Outcome measures
| Measure |
3-Day Posology
n=34 Participants
Decitabine 15 milligram per meter\^2 (mg/m\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
|
5-Day Posology
n=98 Participants
Decitabine 20 mg/m\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
|
|---|---|---|
|
Overall Survival Rate: Percentage of Participants Who Survived During 6 Months and 12 Months of Treatment.
6-month survival rate
|
91.1 Percentage of participants
Interval 74.8 to 97.0
|
84.7 Percentage of participants
Interval 75.9 to 90.5
|
|
Overall Survival Rate: Percentage of Participants Who Survived During 6 Months and 12 Months of Treatment.
12-month survival rate
|
75.9 Percentage of participants
Interval 57.5 to 87.2
|
65.9 Percentage of participants
Interval 55.5 to 74.4
|
SECONDARY outcome
Timeframe: Baseline to end of treatment (approximately up to 2 years)Population: Intent-to-treat (ITT) population- Participants who received at least one dose of study drug. The missing data was imputed by the Last Observation Carried Forward (LOCF).
EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from "1 = not at all" to "4 = very much". Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which will be rated on a 7-point scale ranging from "1 = very poor" to "7 = excellent". Lower scores indicate worsening. Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.
Outcome measures
| Measure |
3-Day Posology
n=34 Participants
Decitabine 15 milligram per meter\^2 (mg/m\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
|
5-Day Posology
n=98 Participants
Decitabine 20 mg/m\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
|
|---|---|---|
|
Mean Change From Baseline to End of Treatment in Scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ C-30) Physical Functioning Scale
|
-5.5 Scores on a scale
Standard Deviation 29.48
|
-9.1 Scores on a scale
Standard Deviation 26.34
|
Adverse Events
3-Day Posology
Serious events: 8 serious events
Other events: 33 other events
Deaths: 0 deaths
5-Day Posology
Serious events: 26 serious events
Other events: 97 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3-Day Posology
n=34 participants at risk
Decitabine 15 milligram per meter\^2 (mg/m\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
|
5-Day Posology
n=98 participants at risk
Decitabine 20 mg/m\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
4.1%
4/98 • Number of events 6 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
2.9%
1/34 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Nervous system disorders
Epilepsy
|
2.9%
1/34 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
0.00%
0/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
10.2%
10/98 • Number of events 13 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
1/34 • Number of events 2 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
5.1%
5/98 • Number of events 7 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Lung infection
|
2.9%
1/34 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
4.1%
4/98 • Number of events 4 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Septic Shock
|
2.9%
1/34 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
2.0%
2/98 • Number of events 2 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Sepsis
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Appendicitis
|
2.9%
1/34 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
0.00%
0/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Bacteraemia
|
2.9%
1/34 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
0.00%
0/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Oral infection
|
2.9%
1/34 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
0.00%
0/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
General disorders
Pyrexia
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma recurrent
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.9%
1/34 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
0.00%
0/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
2.9%
1/34 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
1/34 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
0.00%
0/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Psychiatric disorders
Mental disorder
|
2.9%
1/34 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
0.00%
0/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Surgical and medical procedures
Malignant tumour excision
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Vascular disorders
Hypertension
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
2.9%
1/34 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
0.00%
0/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.9%
1/34 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Anal infection
|
2.9%
1/34 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
0.00%
0/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Infection
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Respiratory tract infection fungal
|
2.9%
1/34 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
0.00%
0/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Rhinitis
|
2.9%
1/34 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
0.00%
0/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.9%
1/34 • Number of events 1 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
0.00%
0/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
Other adverse events
| Measure |
3-Day Posology
n=34 participants at risk
Decitabine 15 milligram per meter\^2 (mg/m\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
|
5-Day Posology
n=98 participants at risk
Decitabine 20 mg/m\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
|
|---|---|---|
|
Investigations
White blood cell count decreased
|
76.5%
26/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
70.4%
69/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Investigations
Platelet count decreased
|
70.6%
24/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
61.2%
60/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Investigations
Neutrophil count decreased
|
61.8%
21/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
53.1%
52/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Investigations
Haemoglobin decreased
|
47.1%
16/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
49.0%
48/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
26.5%
9/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
19.4%
19/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Investigations
Blood albumin decreased
|
14.7%
5/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
9.2%
9/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
8.8%
3/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
11.2%
11/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Investigations
Blood bilirubin increased
|
5.9%
2/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
7.1%
7/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Investigations
Blood creatinine increased
|
2.9%
1/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
6.1%
6/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
General disorders
Pyrexia
|
64.7%
22/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
55.1%
54/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
General disorders
Asthenia
|
14.7%
5/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
16.3%
16/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Constipation
|
17.6%
6/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
15.3%
15/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.6%
6/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
16.3%
16/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal distension
|
17.6%
6/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
10.2%
10/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Mouth ulceration
|
29.4%
10/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
14.3%
14/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
11.8%
4/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
9.2%
9/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
10.2%
10/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.8%
3/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
6.1%
6/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
8.8%
3/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
5.1%
5/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Gingival swelling
|
8.8%
3/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
7.1%
7/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.9%
2/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Proctalgia
|
8.8%
3/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
3.1%
3/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
29.4%
10/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
32.7%
32/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Lung infection
|
23.5%
8/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
23.5%
23/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Infection
|
5.9%
2/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
5.1%
5/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Pneumonia
|
20.6%
7/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
8.2%
8/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
3/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
3.1%
3/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Skin infection
|
5.9%
2/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
4.1%
4/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
8.8%
3/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
2.0%
2/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Gingival infection
|
5.9%
2/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.6%
6/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
13.3%
13/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
17.6%
6/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
12.2%
12/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.9%
2/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.6%
7/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
17.3%
17/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
2.9%
1/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
10.2%
10/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
2/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
3.1%
3/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.6%
7/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
19.4%
19/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
2.9%
1/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
14.3%
14/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.9%
1/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
11.2%
11/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.9%
2/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
4.1%
4/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.8%
3/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
15.3%
15/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.8%
4/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
4.1%
4/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
2/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
2.0%
2/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
2/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
3.1%
3/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
2/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
0.00%
0/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Nervous system disorders
Headache
|
8.8%
3/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
6.1%
6/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Nervous system disorders
Dizziness
|
11.8%
4/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
4.1%
4/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
11.8%
4/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
7.1%
7/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Psychiatric disorders
Insomnia
|
8.8%
3/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
4.1%
4/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Eye disorders
Conjunctival hyperaemia
|
5.9%
2/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
2.0%
2/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Cardiac disorders
Cardiac failure
|
2.9%
1/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
7.1%
7/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Renal and urinary disorders
Haematuria
|
5.9%
2/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
2.0%
2/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
5.9%
2/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
3.1%
3/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
6.1%
6/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Gingival bleeding
|
2.9%
1/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
5.1%
5/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Gingival pain
|
5.9%
2/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
2.0%
2/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Tongue ulceration
|
5.9%
2/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
General disorders
Oedema peripheral
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
10.2%
10/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
General disorders
Chest discomfort
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
5.1%
5/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
General disorders
Chest pain
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
5.1%
5/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Hepatobiliary disorders
Liver disorder
|
20.6%
7/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
6.1%
6/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Infections and infestations
Anal infection
|
8.8%
3/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
0.00%
0/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Investigations
Blood potassium decreased
|
2.9%
1/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
5.1%
5/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Investigations
Blood urea increased
|
0.00%
0/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
5.1%
5/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Investigations
Transaminases increased
|
5.9%
2/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
1.0%
1/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
1/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
7.1%
7/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.9%
2/34 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
2.0%
2/98 • From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
|
Additional Information
SR DIR COMPD DEV TM LDR
Janssen R&D US
Phone: 1 908 704-5197
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60