Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score
A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia · Source last updated 2019-01-09
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
Standard Error
Time frame
Day 1 of each cycle prior to dosing and EoT
What was measured
This questionnaire comprised 30 questions within which are 9 multi-item scales \& 6 single-item measures. There are 5 functional scales; physical, role, cognitive, emotional \& social, 3 symptom scales; fatigue, pain, \& nausea \& vomiting, \& a global health status/quality of life (QoL) scale. There are 5 single item measures assessing additional symptoms commonly reported by cancer patients (loss of appetite, insomnia, constipation, diarrhea, \& dyspnea) \& a single item concerning perceived financial impact of the disease. Most questions used a 4 point scale (1='not at all' to 4='very much'); 2 questions used a 7-point scale (1='very poor' to 7='excellent'). Scores were averaged \& transformed to a scale ranging from 0 to 100; a higher score indicates a better level of functioning or greater degree of symptoms.
Analysis population: ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population
Groups in this outcome
Inotuzumab Ozogamicin
Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\^2 (for a total cycle dose of 1.5 mg/m\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
Defined Investigator's Choice of Chemotherapy
Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.
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
Inotuzumab Ozogamicin
164
Defined Investigator's Choice of Chemotherapy
162
Reported measurements
Physical Functioning C2D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
0.48
1.53
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.32
3.55
Not reported
Not reported
Not reported
Physical Functioning C3D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
3.15
1.97
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-13.33
7.70
Not reported
Not reported
Not reported
Physical Functioning C4D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
5.33
2.84
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
NA
Not reported
Not reported
n=1
Physical Functioning C5D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
11.52
3.51
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Physical Functioning C6D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
7.22
5.94
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Physical Functioning EoT
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-3.38
2.03
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-8.17
2.67
Not reported
Not reported
Not reported
Role Functioning C2D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
5.45
2.79
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-1.59
8.21
Not reported
Not reported
Not reported
Role Functioning C3D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
11.81
3.19
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-11.11
5.56
Not reported
Not reported
Not reported
Role Functioning C4D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
16.67
5.47
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
NA
Not reported
Not reported
n=1
Role Functioning C5D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
12.88
6.10
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Role Functioning C6D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
16.67
11.42
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Role Functioning EoT
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
1.32
3.59
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-12.37
4.09
Not reported
Not reported
Not reported
Emotional Functioning C2D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
5.21
1.76
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
4.76
6.77
Not reported
Not reported
Not reported
Emotional Functioning C3D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
7.41
1.85
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-19.44
10.02
Not reported
Not reported
Not reported
Emotional Functioning C4D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
5.69
1.63
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
NA
Not reported
Not reported
n=1
Emotional Functioning C5D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
6.82
2.83
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Emotional Functioning C6D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
2.78
4.27
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Emotional Functioning EoT
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-0.91
1.80
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
4.35
2.96
Not reported
Not reported
Not reported
Cognitive Functioning C2D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
4.05
1.47
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
3.98
Not reported
Not reported
Not reported
Cognitive Functioning C3D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
5.79
2.11
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-5.56
14.70
Not reported
Not reported
Not reported
Cognitive Functioning C4D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
4.58
2.86
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
16.67
NA
Not reported
Not reported
n=1
Cognitive Functioning C5D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
0.76
4.17
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Cognitive Functioning C6D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-8.33
2.51
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Cognitive Functioning EoT
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
0.83
1.82
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.54
2.89
Not reported
Not reported
Not reported
Social Functioning C2D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
4.20
2.46
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-2.38
7.21
Not reported
Not reported
Not reported
Social Functioning C3D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
5.56
3.25
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-27.78
20.03
Not reported
Not reported
Not reported
Social Functioning C4D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
10.42
4.95
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
NA
Not reported
Not reported
n=1
Social Functioning C5D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
12.88
6.00
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Social Functioning C6D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
16.67
5.03
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Social Functioning EoT
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
1.82
2.84
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-2.15
4.78
Not reported
Not reported
Not reported
Global Health Status C2D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
3.98
2.03
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.40
4.62
Not reported
Not reported
Not reported
Global Health Status C3D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
9.38
3.15
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-16.67
12.73
Not reported
Not reported
Not reported
Global Health Status C4D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
11.25
3.69
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
8.33
NA
Not reported
Not reported
n=1
Global Health Status C5D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
8.71
6.68
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Global Health Status C6D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
0.69
6.76
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Global Health Status EoT
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
0.00
2.83
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-0.40
3.28
Not reported
Not reported
Not reported
Dyspnoea C2D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-5.41
2.72
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-7.94
6.47
Not reported
Not reported
Not reported
Dyspnoea C3D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-7.41
3.24
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
11.11
11.11
Not reported
Not reported
Not reported
Dyspnoea C4D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-12.50
4.25
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
NA
Not reported
Not reported
n=1
Dyspnoea C5D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-3.03
6.55
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Dyspnoea C6D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-2.78
6.43
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Dyspnoea EoT
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-2.31
3.09
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.54
3.95
Not reported
Not reported
Not reported
Insomnia C2D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-2.40
3.01
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
1.59
5.85
Not reported
Not reported
Not reported
Insomnia C3D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-9.26
3.38
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
19.25
Not reported
Not reported
Not reported
Insomnia C4D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-7.50
3.27
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
NA
Not reported
Not reported
n=1
Insomnia C5D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-4.55
4.55
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Insomnia C6D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-11.11
9.48
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Insomnia EoT
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-2.31
3.09
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
3.91
Not reported
Not reported
Not reported
Appetite Loss C2D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-4.20
2.83
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
3.17
7.24
Not reported
Not reported
Not reported
Appetite Loss C3D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-8.33
4.31
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
0.00
Not reported
Not reported
Not reported
Appetite Loss C4D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-11.67
5.54
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
NA
Not reported
Not reported
n=1
Appetite Loss C5D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-6.06
7.80
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Appetite Loss C6D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
2.78
9.59
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Appetite Loss EoT
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-1.32
3.54
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
11.83
4.41
Not reported
Not reported
Not reported
Constipation C2D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-1.21
2.47
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
5.14
Not reported
Not reported
Not reported
Constipation C3D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
0.47
3.44
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
0.00
Not reported
Not reported
Not reported
Constipation C4D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-2.50
3.66
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
NA
Not reported
Not reported
n=1
Constipation C5D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
0.00
5.37
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Constipation C6D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
5.56
5.56
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Constipation EoT
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
2.64
2.60
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-0.54
2.71
Not reported
Not reported
Not reported
Diarrhoea C2D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-3.30
2.17
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-1.59
4.87
Not reported
Not reported
Not reported
Diarrhoea C3D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-5.09
2.61
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-11.11
11.11
Not reported
Not reported
Not reported
Diarrhoea C4D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-0.83
3.27
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
NA
Not reported
Not reported
n=1
Diarrhoea C5D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-9.52
4.68
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Diarrhoea C6D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-2.78
4.95
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Diarrhoea EoT
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
2.31
1.89
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
3.76
3.35
Not reported
Not reported
Not reported
Financial Difficulties C2D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-1.80
1.99
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
8.72
Not reported
Not reported
Not reported
Financial Difficulties C3D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
0.47
3.24
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
0.00
Not reported
Not reported
Not reported
Financial Difficulties C4D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-1.67
3.37
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
NA
Not reported
Not reported
n=1
Financial Difficulties C5D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-3.03
3.74
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Financial Difficulties C6D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-5.56
3.75
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Financial Difficulties EoT
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
0.33
3.09
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
2.19
2.80
Not reported
Not reported
Not reported
Fatigue C2D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-4.10
2.40
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
5.82
6.88
Not reported
Not reported
Not reported
Fatigue C3D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-8.33
3.02
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
22.22
6.42
Not reported
Not reported
Not reported
Fatigue C4D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-9.17
4.64
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-11.11
NA
Not reported
Not reported
n=1
Fatigue C5D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-7.32
5.61
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Fatigue C6D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
0.00
6.42
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Fatigue Eot
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-0.33
2.66
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
5.73
3.27
Not reported
Not reported
Not reported
Nausea and Vomiting C2D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
0.15
2.16
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-0.79
2.69
Not reported
Not reported
Not reported
Nausea and Vomiting C3D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-4.63
2.80
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
0.00
0.00
Not reported
Not reported
Not reported
Nausea and Vomiting C4D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-3.33
3.17
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-16.67
NA
Not reported
Not reported
n=1
Nausea and Vomiting C5D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
2.27
2.96
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Nausea and Vomiting C6D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
0.00
2.90
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Nausea and Vomiting EoT
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-0.17
2.33
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
3.49
2.43
Not reported
Not reported
Not reported
Pain C2D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-8.86
2.71
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-7.14
7.68
Not reported
Not reported
Not reported
Pain C3D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-8.56
3.73
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-5.56
14.70
Not reported
Not reported
Not reported
Pain C4D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-4.17
3.81
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-33.33
NA
Not reported
Not reported
n=1
Pain C5D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
0.76
7.48
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Pain C6D1
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-2.78
9.59
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
NA
NA
Not reported
Not reported
n=0
Pain EoT
Values in Score on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Inotuzumab Ozogamicin
-1.98
2.88
Not reported
Not reported
Not reported
Defined Investigator's Choice of Chemotherapy
-7.26
3.75
Not reported
Not reported
Not reported
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
ci Lower Limit
1.4
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
12.3
group Description
Physical Functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0139
param Type
Mean Difference (Net)
param Value
6.9
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
3.2
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
19.5
group Description
Role Functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0065
param Type
Mean Difference (Net)
param Value
11.4
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
-6.9
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.3
group Description
Emotional Functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.3307
param Type
Mean Difference (Net)
param Value
-2.3
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
-1.4
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
7.0
group Description
Cognitive Functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.1904
param Type
Mean Difference (Net)
param Value
2.8
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
0.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
16.1
group Description
Social Functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0336
param Type
Mean Difference (Net)
param Value
8.4
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
-1.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
10.3
group Description
Global Health Status
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.1572
param Type
Mean Difference (Net)
param Value
4.3
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
-10.8
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.4
group Description
Dyspnoea
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.1281
param Type
Mean Difference (Net)
param Value
-4.7
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
-8.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.2
group Description
Insomnia
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.6207
param Type
Mean Difference (Net)
param Value
-1.7
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
-16.0
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
-1.4
group Description
Appetite Loss
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0193
param Type
Mean Difference (Net)
param Value
-8.7
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
-4.4
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
7.3
group Description
Constipation
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.6249
param Type
Mean Difference (Net)
param Value
1.4
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
-7.2
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.1
group Description
Diarrhoea
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.1534
param Type
Mean Difference (Net)
param Value
-3.0
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
-9.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
4.7
group Description
Financial Difficulties
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.4915
param Type
Mean Difference (Net)
param Value
-2.5
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
Complete source fields
analyses
ci Lower Limit
1.4
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
12.3
group Description
Physical Functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0139
param Type
Mean Difference (Net)
param Value
6.9
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
3.2
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
19.5
group Description
Role Functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0065
param Type
Mean Difference (Net)
param Value
11.4
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
-6.9
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.3
group Description
Emotional Functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.3307
param Type
Mean Difference (Net)
param Value
-2.3
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
-1.4
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
7.0
group Description
Cognitive Functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.1904
param Type
Mean Difference (Net)
param Value
2.8
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
0.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
16.1
group Description
Social Functioning
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0336
param Type
Mean Difference (Net)
param Value
8.4
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
-1.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
10.3
group Description
Global Health Status
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.1572
param Type
Mean Difference (Net)
param Value
4.3
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
-10.8
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.4
group Description
Dyspnoea
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.1281
param Type
Mean Difference (Net)
param Value
-4.7
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
-8.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.2
group Description
Insomnia
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.6207
param Type
Mean Difference (Net)
param Value
-1.7
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
-16.0
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
-1.4
group Description
Appetite Loss
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0193
param Type
Mean Difference (Net)
param Value
-8.7
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
-4.4
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
7.3
group Description
Constipation
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.6249
param Type
Mean Difference (Net)
param Value
1.4
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
-7.2
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.1
group Description
Diarrhoea
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.1534
param Type
Mean Difference (Net)
param Value
-3.0
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
ci Lower Limit
-9.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
4.7
group Description
Financial Difficulties
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.4915
param Type
Mean Difference (Net)
param Value
-2.5
statistical Comment
Treatment, time, treatment-by-time interaction, and baseline included as covariate.
statistical Method
Mixed Models Analysis
classes
categories
measurements
group Id
OG000
spread
1.53
value
0.48
group Id
OG001
spread
3.55
value
0.32
title
Physical Functioning C2D1
categories
measurements
group Id
OG000
spread
1.97
value
3.15
group Id
OG001
spread
7.70
value
-13.33
title
Physical Functioning C3D1
categories
measurements
group Id
OG000
spread
2.84
value
5.33
comment
n=1
group Id
OG001
spread
NA
value
0.00
title
Physical Functioning C4D1
categories
measurements
group Id
OG000
spread
3.51
value
11.52
comment
n=0
group Id
OG001
spread
NA
value
NA
title
Physical Functioning C5D1
categories
measurements
group Id
OG000
spread
5.94
value
7.22
comment
n=0
group Id
OG001
spread
NA
value
NA
title
Physical Functioning C6D1
categories
measurements
group Id
OG000
spread
2.03
value
-3.38
group Id
OG001
spread
2.67
value
-8.17
title
Physical Functioning EoT
categories
measurements
group Id
OG000
spread
2.79
value
5.45
group Id
OG001
spread
8.21
value
-1.59
title
Role Functioning C2D1
categories
measurements
group Id
OG000
spread
3.19
value
11.81
group Id
OG001
spread
5.56
value
-11.11
title
Role Functioning C3D1
categories
measurements
group Id
OG000
spread
5.47
value
16.67
comment
n=1
group Id
OG001
spread
NA
value
0.00
title
Role Functioning C4D1
categories
measurements
group Id
OG000
spread
6.10
value
12.88
comment
n=0
group Id
OG001
spread
NA
value
NA
title
Role Functioning C5D1
categories
measurements
group Id
OG000
spread
11.42
value
16.67
comment
n=0
group Id
OG001
spread
NA
value
NA
title
Role Functioning C6D1
categories
measurements
group Id
OG000
spread
3.59
value
1.32
group Id
OG001
spread
4.09
value
-12.37
title
Role Functioning EoT
denoms
counts
group Id
OG000
value
164
group Id
OG001
value
162
units
Participants
description
This questionnaire comprised 30 questions within which are 9 multi-item scales \& 6 single-item measures. There are 5 functional scales; physical, role, cognitive, emotional \& social, 3 symptom scales; fatigue, pain, \& nausea \& vomiting, \& a global health status/quality of life (QoL) scale. There are 5 single item measures assessing additional symptoms commonly reported by cancer patients (loss of appetite, insomnia, constipation, diarrhea, \& dyspnea) \& a single item concerning perceived financial impact of the disease. Most questions used a 4 point scale (1='not at all' to 4='very much'); 2 questions used a 7-point scale (1='very poor' to 7='excellent'). Scores were averaged \& transformed to a scale ranging from 0 to 100; a higher score indicates a better level of functioning or greater degree of symptoms.
dispersion Type
Standard Error
groups
description
Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\^2 (for a total cycle dose of 1.5 mg/m\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
id
OG000
title
Inotuzumab Ozogamicin
description
Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.
id
OG001
title
Defined Investigator's Choice of Chemotherapy
param Type
MEAN
population Description
ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population
reporting Status
POSTED
time Frame
Day 1 of each cycle prior to dosing and EoT
title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score
Triangle