Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant · Source last updated 2024-02-15
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
score on a scale
Interval / dispersion
Full Range
Time frame
EORTC QLQ-C30 questionnaire will be collected at screening, after completion of therapy (HMA 4-6 month, and up to 6 months for induction-like chemotherapy) just prior to stem cell infusion and 100 (± 14) days after stem cell infusion (HSCT).
What was measured
The European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) (version 3) is a 30-item cancer-specific questionnaire for measuring the health-related quality of life (QOL) in cancer patients. It includes five functioning scales (physical, PF; role, RF; cognitive, CF; emotional, EF; and social, SF), three symptom scales (fatigue, FA; pain, PA; and nausea and vomiting, NV), a global health status/QOL scale (GL), and six single items (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial impact of the disease and treatment). All items employ a 4-point Likert scale, ranging from 1 (not at all) to 4 (very much) with lower scores representing a better outcome and higher scores a worse outcome; with the exception of two items in the GL scale, which use 7-point scales (1=very poor to 7=excellent) lower scores representing a worse outcome and higher score representing a better outcome.
Analysis population: The QLQ-C30 is a validated and widely used questionnaire to assess QOL in cancer patients. For Arm A (Azacitidine or Decitabine) only 22 subjects submitted EORTC QLQ-C30 at screening; 14 subjects completed EORTC QLQ-C30 at pre-transplant and 10 subjects post-transplant. For Arm B (induction chemo) 25 subjects submitted EORTC QLQ-C30 at screening; 13 subjects completed QLQ-C30 at pre-transplant and 10 subjects post-transplant. Scores for each question and timepoints were averaged to obtain mean.
Groups in this outcome
Arm A (Azacitidine or Decitabine)
Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.
Azacitidine (AZC): Given IV or SC
Decitabine: Given IV or SC
Arm B (Induction Like Chemotherapy)
Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
25
Arm B (Induction Like Chemotherapy)
25
Reported measurements
EORTCQLQ-C30 at Screening 1. Do you have any trouble doing strenuous activities?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.27
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.72
Not reported
1
4
Not reported
EORTCQLQ-C30 at Pre-Transplant 1. Do you have any trouble doing strenuous activities?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.14
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
2.0
Not reported
1
4
Not reported
EORTCQLQ-C30 at post-transplant 1. Do you have any trouble doing strenuous activities?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.0
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.81
Not reported
1
4
Not reported
EORTCQLQ-C30 at Screening 2. Do you have any trouble taking a long walk?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.40
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.96
Not reported
1
4
Not reported
EORTCQLQ-C30 at Pre-transplant 2. Do you have any trouble taking a long walk?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.85
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.83
Not reported
1
4
Not reported
EORTCQLQ-C30 at Post-transplant 2. Do you have any trouble taking a long walk?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.9
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.63
Not reported
1
4
Not reported
EORTCQLQ-C30 at Screening 3. Do you have any trouble taking a short walk outside of the house?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.5
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.24
Not reported
1
4
Not reported
EORTCQLQ-C30 at Pre-transplant 3. Do you have any trouble taking a short walk outside of the house?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.42
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.30
Not reported
1
4
Not reported
EORTCQLQ-C30 at Post-transplant 3.Do you have any trouble taking a short walk outside of the house?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.1
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.4
Not reported
1
4
Not reported
EORTCQLQ-C30 at Screening 4. Do you need to stay in bed or a chair during the day?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.68
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.66
Not reported
1
4
Not reported
EORTCQLQ-C30 at Pre transplant 4. Do you need to stay in bed or a chair during the day?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.42
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.30
Not reported
1
4
Not reported
EORTCQLQ-C30 at Post-transplant 4. Do you need to stay in bed or a chair during the day?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.45
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.5
Not reported
1
4
Not reported
EORTCQLQ-C30 at Screening 5. Do you need help with eating, dressing, washing yourself?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.04
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.08
Not reported
1
4
Not reported
EORTCQLQ-C30 at Pre-transplant 5. Do you need help with eating, dressing, washing yourself?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1
Not reported
1
4
Not reported
EORTCQLQ-C30 at Post-transplant 5. Do you need help with eating, dressing, washing yourself?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
25
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1
Not reported
1
4
Not reported
EORTCQLQ-C30 at Screening 6. Were you limited in doing either your work or other daily activities?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.22
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.92
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-transplant 6.Were you limited in doing either your work or other daily activities?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.07
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.61
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-Transplant 6.Were you limited in doing either your work/ other daily activities?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.8
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.8
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 7.Were you limited in pursing your hobbies or other leisure time activities?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.52
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.88
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-transplant 7.Were you limited in pursing your hobbies/other leisure activities?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.07
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.85
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-transplant 7.Were you limited in pursing your hobbies/other leisure activities?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.9
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.8
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 8. Were you short of breath?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.22
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
2
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-transplant 8. Were you short of breath?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.85
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.31
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-transplant 8. Were you short of breath?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.5
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.33
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 9. Have you had pain?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.54
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.48
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-transplant 9. Have you had pain?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.78
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.46
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-transplant 9. Have you had pain?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.6
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.4
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 10. Did you need to rest?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.38
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
2.16
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-transplant 10. Did you need to rest?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.21
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
2.15
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-transplant 10. Did you need to rest?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.9
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
2.0
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 11. Have you had trouble sleeping?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.0
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.8
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-transplant 11. Have you had trouble sleeping?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.35
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.69
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-transplant 11. Have you had trouble sleeping?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.0
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.6
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 12. Have you felt weak?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.42
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
2.04
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-transplant 12. Have you felt weak?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.85
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.77
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-transplant 12. Have you felt weak?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.1
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.7
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 13. Have you lacked appetite?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.54
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.72
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-transplant 13. Have you lacked appetite?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.71
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.85
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-transplant 13. Have you lacked appetite?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.5
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.70
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 14. Have you felt nauseated?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.31
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.4
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-transplant 14. Have you felt nauseated?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.07
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.53
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-transplant 14. Have you felt nauseated?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.5
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.4
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 15. Have you vomited?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.09
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.12
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-transplant 15. Have you vomited?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.08
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-transplant 15. Have you vomited?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.1
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.1
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 16. Have you been constipated?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.31
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.52
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-transplant 16. Have you been constipated?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.21
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.38
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-transplant 16. Have you been constipated?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 17. Have you had diarrhea?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.45
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.20
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-transplant 17. Have you had diarrhea?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.23
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.23
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-transplant 17. Have you had diarrhea?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.0
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.5
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 18. Were you tired?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.45
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
2.4
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-transplant 18. Were you tired?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.23
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
2.31
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-transplant 18. Were you tired?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
25
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.10
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
2.20
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 19. Did pain interfere with your daily activities?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.27
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.48
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-transplant 19. Did pain interfere with your daily activities?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.61
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.38
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-transplant 19. Did pain interfere with your daily activities?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.5
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.4
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 20. Difficulty concentrating on things like reading a or watching TV?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.81
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.32
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-transplant 20. Difficulty concentrating on things like reading a or watching TV?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.69
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.30
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-transplant 20. Difficulty concentrating on things like reading a or watching TV?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.3
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.2
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 21. Did you feel tense?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.72
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.60
Not reported
1
4
Not reported
EORTCQLQ-C30 pre-transplant 21. Did you feel tense?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.92
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.31
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-transplant 21. Did you feel tense?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.5
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.4
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 22. Did you worry?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.13
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.68
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-transplant 22. Did you worry?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.0
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.92
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-transplant 22. Did you worry?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.8
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.7
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 23. Did you feel irritable?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.63
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.41
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-Transplant 23. Did you feel irritable?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.77
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.54
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-Transplant 23. Did you feel irritable?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.7
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.6
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 24. Did you feel depressed?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.68
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.48
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-Transplant 24. Did you feel depressed?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.41
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.46
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-Transplant 24. Did you feel depressed?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.5
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.5
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 25. Have you had difficulty remembering things?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.86
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.60
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-transplant 25. Have you had difficulty remembering things?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.84
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.54
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-transplant 25. Have you had difficulty remembering things?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.9
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.6
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 26. Has your physical condition/medical treatment interfere with family?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.90
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.48
Not reported
1
4
Not reported
EORTCQLQ-C30 Pre-transplant 26.Has your physical condition/medical treatment interfere w/family?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.15
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
2.07
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-transplant 26.Has your physical condition/medical treatment interfere w/family?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
1.8
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.7
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 27.Has your physical condition/medical treatment interfere w/social life?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.09
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
1.92
Not reported
1
4
Not reported
EORTCQLQ-C30Pre-transplant 27.Has your physical condition/medical treatment interfere w/social life?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.5
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
2.38
Not reported
1
4
Not reported
EORTCQLQ-C30 Post-trans 27.Has your physical condition/medical treatment interfere w/social life?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
2.0
Not reported
1
4
Not reported
Arm B (Induction Like Chemotherapy)
2.0
Not reported
1
4
Not reported
EORTCQLQ-C30 Screening 29.How would you rate your overall health during the past week?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
4.52
Not reported
1
7
Not reported
Arm B (Induction Like Chemotherapy)
4.86
Not reported
1
7
Not reported
EORTCQLQ-C30 Pre-transplant 29.How would you rate your overall health during the past week?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
4.77
Not reported
1
7
Not reported
Arm B (Induction Like Chemotherapy)
4.61
Not reported
1
7
Not reported
EORTCQLQ-C30 Post-transplant 29.How would you rate your overall health during the past week?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
5.4
Not reported
1
7
Not reported
Arm B (Induction Like Chemotherapy)
5.1
Not reported
1
7
Not reported
EORTCQLQ-C30 Screening 30. How would you rate your overall quality of life during the past week?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
22
Arm B (Induction Like Chemotherapy)
25
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
4.5
Not reported
1
7
Not reported
Arm B (Induction Like Chemotherapy)
5.12
Not reported
1
7
Not reported
EORTCQLQ-C30 Pretransplant 30.How would you rate your overall quality of life during the past week?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
14
Arm B (Induction Like Chemotherapy)
13
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
4.46
Not reported
1
7
Not reported
Arm B (Induction Like Chemotherapy)
4.69
Not reported
1
7
Not reported
EORTCQLQ-C30 Posttransplant 30.How would you rate your overall QoL during the past week?
Analysis denominator · Participants
Group
Source count
Arm A (Azacitidine or Decitabine)
10
Arm B (Induction Like Chemotherapy)
10
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Arm A (Azacitidine or Decitabine)
5.1
Not reported
1
7
Not reported
Arm B (Induction Like Chemotherapy)
5.1
Not reported
1
7
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
2.27
group Id
OG001
lower Limit
1
upper Limit
4
value
1.72
denoms
counts
group Id
OG000
value
22
group Id
OG001
value
25
units
Participants
title
EORTCQLQ-C30 at Screening 1. Do you have any trouble doing strenuous activities?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
2.14
group Id
OG001
lower Limit
1
upper Limit
4
value
2.0
denoms
counts
group Id
OG000
value
14
group Id
OG001
value
13
units
Participants
title
EORTCQLQ-C30 at Pre-Transplant 1. Do you have any trouble doing strenuous activities?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
2.0
group Id
OG001
lower Limit
1
upper Limit
4
value
1.81
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
10
units
Participants
title
EORTCQLQ-C30 at post-transplant 1. Do you have any trouble doing strenuous activities?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
2.40
group Id
OG001
lower Limit
1
upper Limit
4
value
1.96
denoms
counts
group Id
OG000
value
22
group Id
OG001
value
25
units
Participants
title
EORTCQLQ-C30 at Screening 2. Do you have any trouble taking a long walk?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.85
group Id
OG001
lower Limit
1
upper Limit
4
value
1.83
denoms
counts
group Id
OG000
value
14
group Id
OG001
value
13
units
Participants
title
EORTCQLQ-C30 at Pre-transplant 2. Do you have any trouble taking a long walk?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.9
group Id
OG001
lower Limit
1
upper Limit
4
value
1.63
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
10
units
Participants
title
EORTCQLQ-C30 at Post-transplant 2. Do you have any trouble taking a long walk?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.5
group Id
OG001
lower Limit
1
upper Limit
4
value
1.24
denoms
counts
group Id
OG000
value
22
group Id
OG001
value
25
units
Participants
title
EORTCQLQ-C30 at Screening 3. Do you have any trouble taking a short walk outside of the house?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.42
group Id
OG001
lower Limit
1
upper Limit
4
value
1.30
denoms
counts
group Id
OG000
value
14
group Id
OG001
value
13
units
Participants
title
EORTCQLQ-C30 at Pre-transplant 3. Do you have any trouble taking a short walk outside of the house?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.1
group Id
OG001
lower Limit
1
upper Limit
4
value
1.4
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
10
units
Participants
title
EORTCQLQ-C30 at Post-transplant 3.Do you have any trouble taking a short walk outside of the house?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.68
group Id
OG001
lower Limit
1
upper Limit
4
value
1.66
denoms
counts
group Id
OG000
value
22
group Id
OG001
value
25
units
Participants
title
EORTCQLQ-C30 at Screening 4. Do you need to stay in bed or a chair during the day?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.42
group Id
OG001
lower Limit
1
upper Limit
4
value
1.30
denoms
counts
group Id
OG000
value
14
group Id
OG001
value
13
units
Participants
title
EORTCQLQ-C30 at Pre transplant 4. Do you need to stay in bed or a chair during the day?
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
4
value
1.45
group Id
OG001
lower Limit
1
upper Limit
4
value
1.5
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
10
units
Participants
title
EORTCQLQ-C30 at Post-transplant 4. Do you need to stay in bed or a chair during the day?
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
25
units
Participants
description
The European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) (version 3) is a 30-item cancer-specific questionnaire for measuring the health-related quality of life (QOL) in cancer patients. It includes five functioning scales (physical, PF; role, RF; cognitive, CF; emotional, EF; and social, SF), three symptom scales (fatigue, FA; pain, PA; and nausea and vomiting, NV), a global health status/QOL scale (GL), and six single items (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial impact of the disease and treatment). All items employ a 4-point Likert scale, ranging from 1 (not at all) to 4 (very much) with lower scores representing a better outcome and higher scores a worse outcome; with the exception of two items in the GL scale, which use 7-point scales (1=very poor to 7=excellent) lower scores representing a worse outcome and higher score representing a better outcome.
dispersion Type
Full Range
groups
description
Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.
Azacitidine (AZC): Given IV or SC
Decitabine: Given IV or SC
id
OG000
title
Arm A (Azacitidine or Decitabine)
description
Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only.
id
OG001
title
Arm B (Induction Like Chemotherapy)
param Type
MEAN
population Description
The QLQ-C30 is a validated and widely used questionnaire to assess QOL in cancer patients. For Arm A (Azacitidine or Decitabine) only 22 subjects submitted EORTC QLQ-C30 at screening; 14 subjects completed EORTC QLQ-C30 at pre-transplant and 10 subjects post-transplant. For Arm B (induction chemo) 25 subjects submitted EORTC QLQ-C30 at screening; 13 subjects completed QLQ-C30 at pre-transplant and 10 subjects post-transplant. Scores for each question and timepoints were averaged to obtain mean.
reporting Status
POSTED
time Frame
EORTC QLQ-C30 questionnaire will be collected at screening, after completion of therapy (HMA 4-6 month, and up to 6 months for induction-like chemotherapy) just prior to stem cell infusion and 100 (± 14) days after stem cell infusion (HSCT).
title
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
Triangle