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NCT02195869 · OUTCOME

Corticosteroid Requirement Changes Over Time

Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease · Source last updated 2019-07-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEDIAN
Unit: Daily Dose of Steroid by Weight (mg/kg/d
Interval / dispersion: Full Range
Time frame: Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.

What was measured

Average daily corticosteroid dose assessed each week.

Analysis population: Phase 2 subjects includes all subjects who participated in Phase 1b.

Groups in this outcome

Phase 1b/Phase 2

Subjects receive daily dose of 420 mg of Ibrutinib capsules

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
Phase 1b/Phase 2	42

Reported measurements

Week 1

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	42

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.31	Not reported	0.06	1.3	Not reported

Week 2

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	42

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.32	Not reported	0.06	1.35	Not reported

Week 3

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	42

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.32	Not reported	0.06	1.35	Not reported

Week 4

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	41

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.31	Not reported	0.06	1.35	Not reported

Week 5

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	41

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.31	Not reported	0.06	1.53	Not reported

Week 6

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	41

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.30	Not reported	0.06	1.53	Not reported

Week 7

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	41

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.30	Not reported	0.06	1.53	Not reported

Week 8

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	39

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.30	Not reported	0.01	1.53	Not reported

Week 9

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	37

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.27	Not reported	0.00	1.03	Not reported

Week 10

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	36

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.25	Not reported	0.00	1.54	Not reported

Week 11

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	33

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.25	Not reported	0.00	2.02	Not reported

Week 12

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	30

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.25	Not reported	0.00	0.62	Not reported

Week 13

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	29

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.24	Not reported	0.00	0.62	Not reported

Week 14

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	28

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.23	Not reported	0.00	0.57	Not reported

Week 15

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	28

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.23	Not reported	0.00	0.58	Not reported

Week 16

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	27

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.23	Not reported	0.00	0.48	Not reported

Week 17

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	26

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.21	Not reported	0.00	0.47	Not reported

Week 18

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	26

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.20	Not reported	0.00	0.44	Not reported

Week 19

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	26

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.20	Not reported	0.00	0.44	Not reported

Week 20

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	26

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.21	Not reported	0.00	0.44	Not reported

Week 21

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	26

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.22	Not reported	0.00	0.37	Not reported

Week 22

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	26

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.22	Not reported	0.00	0.37	Not reported

Week 23

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	26

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.22	Not reported	0.00	0.60	Not reported

Week 24

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	26

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.21	Not reported	0.00	0.37	Not reported

Week 25

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	26

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.19	Not reported	0.00	0.38	Not reported

Week 26

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	23

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.18	Not reported	0.00	0.37	Not reported

Week 27

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	23

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.18	Not reported	0.00	0.37	Not reported

Week 28

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	23

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.18	Not reported	0.00	0.37	Not reported

Week 29

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	23

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.16	Not reported	0.00	0.37	Not reported

Week 30

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	23

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.16	Not reported	0.00	0.32	Not reported

Week 31

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	23

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.16	Not reported	0.00	0.29	Not reported

Week 32

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	22

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.18	Not reported	0.00	0.29	Not reported

Week 33

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	22

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.17	Not reported	0.00	0.29	Not reported

Week 34

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	22

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.17	Not reported	0.00	0.29	Not reported

Week 35

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	21

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.18	Not reported	0.00	0.29	Not reported

Week 36

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	21

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.18	Not reported	0.00	0.29	Not reported

Week 37

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	21

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.16	Not reported	0.00	0.29	Not reported

Week 38

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	21

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.15	Not reported	0.00	0.35	Not reported

Week 39

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	20

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.15	Not reported	0.00	0.30	Not reported

Week 40

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	20

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.15	Not reported	0.00	0.30	Not reported

Week 41

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	20

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.15	Not reported	0.00	0.30	Not reported

Week 42

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	20

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.15	Not reported	0.00	0.30	Not reported

Week 43

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	20

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.13	Not reported	0.00	0.30	Not reported

Week 44

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	20

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.13	Not reported	0.00	0.21	Not reported

Week 45

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	20

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.13	Not reported	0.00	0.21	Not reported

Week 46

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	19

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.13	Not reported	0.00	0.60	Not reported

Week 47

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	19

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.13	Not reported	0.00	0.60	Not reported

Week 48

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	19

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.13	Not reported	0.00	0.53	Not reported

Week 49

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	19

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.12	Not reported	0.00	0.46	Not reported

Week 50

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	19

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.10	Not reported	0.00	0.36	Not reported

Week 51

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	19

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.10	Not reported	0.00	0.24	Not reported

Week 52

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	19

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.10	Not reported	0.00	0.24	Not reported

Week 53

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	19

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.10	Not reported	0.00	0.24	Not reported

Week 54

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	19

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.10	Not reported	0.00	0.24	Not reported

Week 55

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	19

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.10	Not reported	0.00	0.24	Not reported

Week 56

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	19

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.10	Not reported	0.00	0.24	Not reported

Week 57

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	19

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.10	Not reported	0.00	0.24	Not reported

Week 58

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	18

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.10	Not reported	0.00	0.21	Not reported

Week 59

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	18

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.10	Not reported	0.00	0.27	Not reported

Week 60

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	18

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.21	Not reported

Week 61

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	18

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.21	Not reported

Week 62

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	16

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.21	Not reported

Week 63

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	16

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.21	Not reported

Week 64

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	16

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.21	Not reported

Week 65

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	16

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.21	Not reported

Week 66

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	16

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.21	Not reported

Week 67

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	16

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.21	Not reported

Week 68

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	16

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.21	Not reported

Week 69

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	16

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.21	Not reported

Week 70

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	15

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.21	Not reported

Week 71

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	15

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.07	Not reported	0.00	0.21	Not reported

Week 72

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	15

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.21	Not reported

Week 73

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	15

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.21	Not reported

Week 74

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	14

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.07	Not reported	0.00	0.21	Not reported

Week 75

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	14

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.07	Not reported	0.00	0.20	Not reported

Week 76

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	14

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.07	Not reported	0.00	0.20	Not reported

Week 77

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	14

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.07	Not reported	0.00	0.20	Not reported

Week 78

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	14

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.07	Not reported	0.00	0.20	Not reported

Week 79

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	14

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.07	Not reported	0.00	0.20	Not reported

Week 80

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	14

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.07	Not reported	0.00	0.20	Not reported

Week 81

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	14

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.07	Not reported	0.00	0.27	Not reported

Week 82

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	14

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.07	Not reported	0.00	0.31	Not reported

Week 83

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	14

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.07	Not reported	0.00	0.31	Not reported

Week 84

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	13

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.07	Not reported	0.00	0.31	Not reported

Week 85

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	12

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.31	Not reported

Week 86

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	12

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.32	Not reported

Week 87

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	12

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.32	Not reported

Week 88

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	12

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.32	Not reported

Week 89

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	12

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 90

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	12

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 91

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	12

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 92

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	12

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 93

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	12

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 94

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	12

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 95

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	11

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 96

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	11

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 97

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	11

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 98

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	11

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 99

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	11

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 100

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	11

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 101

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	11

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.09	Not reported	0.00	0.95	Not reported

Week 102

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	11

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.09	Not reported	0.00	0.95	Not reported

Week 103

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	11

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.09	Not reported	0.00	0.95	Not reported

Week 104

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	11

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.09	Not reported	0.00	0.95	Not reported

Week 105

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	11

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 106

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	11

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 107

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	11

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 108

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	11

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 109

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	11

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 110

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	11

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 111

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	11

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 112

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	9

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 113

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	8

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 114

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	8

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 115

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	8

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.12	Not reported	0.00	0.95	Not reported

Week 116

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	8

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.12	Not reported	0.00	0.95	Not reported

Week 117

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	7

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 118

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	7

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 119

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	7

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 120

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	7

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 121

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	7

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.95	Not reported

Week 122

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	6

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.12	Not reported	0.00	0.95	Not reported

Week 123

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	5

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.22	Not reported

Week 124

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	5

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.22	Not reported

Week 125

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	5

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.22	Not reported

Week 126

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	4

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.22	Not reported

Week 127

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	4

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.08	Not reported	0.00	0.22	Not reported

Week 128

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.22	Not reported

Week 129

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.22	Not reported

Week 130

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.22	Not reported

Week 131

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.19	Not reported

Week 132

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.15	Not reported

Week 133

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.15	Not reported

Week 134

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.15	Not reported

Week 135

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.15	Not reported

Week 136

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.15	Not reported

Week 137

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.15	Not reported

Week 138

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.15	Not reported

Week 139

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.15	Not reported

Week 140

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.15	Not reported

Week 141

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.16	Not reported

Week 142

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.17	Not reported

Week 143

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.17	Not reported

Week 144

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.17	Not reported

Week 145

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.17	Not reported

Week 146

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.17	Not reported

Week 147

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.17	Not reported

Week 148

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.17	Not reported

Week 149

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.17	Not reported

Week 150

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.17	Not reported

Week 151

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.17	Not reported

Week 152

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.17	Not reported

Week 153

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.15	Not reported

Week 154

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.14	Not reported

Week 155

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.14	Not reported

Week 156

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.14	Not reported

Week 157

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	3

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.00	Not reported	0.00	0.13	Not reported

Week 158

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	2

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.06	Not reported	0.00	0.11	Not reported

Week 159

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	2

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.06	Not reported	0.00	0.11	Not reported

Week 160

Analysis denominator · Participants

Group	Source count
Phase 1b/Phase 2	2

Values in Daily Dose of Steroid by Weight (mg/kg/d · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1b/Phase 2	0.06	Not reported	0.00	0.11	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.06
upper Limit
1.3
value
0.31
denoms
counts
group Id
OG000
value
42
units
Participants
title
Week 1
categories
measurements
group Id
OG000
lower Limit
0.06
upper Limit
1.35
value
0.32
denoms
counts
group Id
OG000
value
42
units
Participants
title
Week 2
categories
measurements
group Id
OG000
lower Limit
0.06
upper Limit
1.35
value
0.32
denoms
counts
group Id
OG000
value
42
units
Participants
title
Week 3
categories
measurements
group Id
OG000
lower Limit
0.06
upper Limit
1.35
value
0.31
denoms
counts
group Id
OG000
value
41
units
Participants
title
Week 4
categories
measurements
group Id
OG000
lower Limit
0.06
upper Limit
1.53
value
0.31
denoms
counts
group Id
OG000
value
41
units
Participants
title
Week 5
categories
measurements
group Id
OG000
lower Limit
0.06
upper Limit
1.53
value
0.30
denoms
counts
group Id
OG000
value
41
units
Participants
title
Week 6
categories
measurements
group Id
OG000
lower Limit
0.06
upper Limit
1.53
value
0.30
denoms
counts
group Id
OG000
value
41
units
Participants
title
Week 7
categories
measurements
group Id
OG000
lower Limit
0.01
upper Limit
1.53
value
0.30
denoms
counts
group Id
OG000
value
39
units
Participants
title
Week 8
categories
measurements
group Id
OG000
lower Limit
0.00
upper Limit
1.03
value
0.27
denoms
counts
group Id
OG000
value
37
units
Participants
title
Week 9
categories
measurements
group Id
OG000
lower Limit
0.00
upper Limit
1.54
value
0.25
denoms
counts
group Id
OG000
value
36
units
Participants
title
Week 10
categories
measurements
group Id
OG000
lower Limit
0.00
upper Limit
2.02
value
0.25
denoms
counts
group Id
OG000
value
33
units
Participants
title
Week 11
categories
measurements
group Id
OG000
lower Limit
0.00
upper Limit
0.62
value
0.25
denoms
counts
group Id
OG000
value
30
units
Participants
title
Week 12

denoms

counts
group Id
OG000
value
42
units
Participants

description

Average daily corticosteroid dose assessed each week.

dispersion Type

Full Range

groups

description
Subjects receive daily dose of 420 mg of Ibrutinib capsules
id
OG000
title
Phase 1b/Phase 2

param Type

MEDIAN

population Description

Phase 2 subjects includes all subjects who participated in Phase 1b.

reporting Status

POSTED

time Frame

Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.

title

Corticosteroid Requirement Changes Over Time

type

SECONDARY

unit Of Measure

Daily Dose of Steroid by Weight (mg/kg/d

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice