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NCT01524783 · OUTCOME

Change From Baseline in Chromogranin A (CgA) Levels

Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin) · Source last updated 2021-08-05

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

Measure: MEAN
Unit: microgram/liter (ug/L)
Interval / dispersion: Standard Deviation
Time frame: From baseline (every 4 weeks) up to 116 weeks

What was measured

CgA is a potential biomarker for tumor response. Blood samples were collected for assessment of CgA levels. Change from Baseline at a particular visit was calculated as the CgA level at that visit minus Baseline.

Analysis population: The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization. Number analyzed signified number of participants with available data for this outcome measure at specified timepoints.

Groups in this outcome

Everolimus + BSC

Participants received everolimus 10 mg once daily BSC throughout the study

Placebo + BSC

Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period

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
Everolimus + BSC	205
Placebo + BSC	97

Reported measurements

Week 4

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	164
Placebo + BSC	90

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	434.8	2306.70	Not reported	Not reported	Not reported
Placebo + BSC	1154.3	9083.39	Not reported	Not reported	Not reported

Week 8

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	156
Placebo + BSC	88

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	162.3	2550.65	Not reported	Not reported	Not reported
Placebo + BSC	2697.6	19956.90	Not reported	Not reported	Not reported

Week 12

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	143
Placebo + BSC	75

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	396.7	2401.78	Not reported	Not reported	Not reported
Placebo + BSC	1176.0	3322.13	Not reported	Not reported	Not reported

Week 16

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	141
Placebo + BSC	62

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	263.5	2946.76	Not reported	Not reported	Not reported
Placebo + BSC	1450.4	4825.78	Not reported	Not reported	Not reported

Week 20

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	131
Placebo + BSC	51

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	162.1	2464.47	Not reported	Not reported	Not reported
Placebo + BSC	3640.1	12653.42	Not reported	Not reported	Not reported

Week 24

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	119
Placebo + BSC	39

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	253.2	3487.27	Not reported	Not reported	Not reported
Placebo + BSC	1783.9	5399.98	Not reported	Not reported	Not reported

Week 28

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	112
Placebo + BSC	35

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	587.2	4861.35	Not reported	Not reported	Not reported
Placebo + BSC	1350.3	5701.70	Not reported	Not reported	Not reported

Week 32

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	109
Placebo + BSC	31

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	508.5	6102.61	Not reported	Not reported	Not reported
Placebo + BSC	2000.7	6362.83	Not reported	Not reported	Not reported

Week 36

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	97
Placebo + BSC	26

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	94.7	4905.17	Not reported	Not reported	Not reported
Placebo + BSC	180.9	383.93	Not reported	Not reported	Not reported

Week 40

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	87
Placebo + BSC	24

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	511.4	6180.67	Not reported	Not reported	Not reported
Placebo + BSC	207.6	403.30	Not reported	Not reported	Not reported

Week 44

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	86
Placebo + BSC	23

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	552.8	4173.44	Not reported	Not reported	Not reported
Placebo + BSC	140.6	328.02	Not reported	Not reported	Not reported

Week 48

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	77
Placebo + BSC	23

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	1326.2	8718.92	Not reported	Not reported	Not reported
Placebo + BSC	129.0	326.69	Not reported	Not reported	Not reported

Week 52

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	70
Placebo + BSC	24

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	1196.2	7737.76	Not reported	Not reported	Not reported
Placebo + BSC	124.2	452.38	Not reported	Not reported	Not reported

Week 56

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	60
Placebo + BSC	21

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	1920.6	11250.07	Not reported	Not reported	Not reported
Placebo + BSC	134.9	346.33	Not reported	Not reported	Not reported

Week 60

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	60
Placebo + BSC	19

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	1722.0	13155.03	Not reported	Not reported	Not reported
Placebo + BSC	120.9	415.73	Not reported	Not reported	Not reported

Week 64

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	59
Placebo + BSC	19

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	3811.0	26656.45	Not reported	Not reported	Not reported
Placebo + BSC	141.6	281.38	Not reported	Not reported	Not reported

Week 68

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	56
Placebo + BSC	17

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	1413.3	9588.68	Not reported	Not reported	Not reported
Placebo + BSC	222.6	333.93	Not reported	Not reported	Not reported

Week 72

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	53
Placebo + BSC	17

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	239.5	2318.79	Not reported	Not reported	Not reported
Placebo + BSC	233.7	400.43	Not reported	Not reported	Not reported

Week 76

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	51
Placebo + BSC	16

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	3256.5	19395.40	Not reported	Not reported	Not reported
Placebo + BSC	210.9	522.62	Not reported	Not reported	Not reported

Week 80

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	49
Placebo + BSC	15

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	5421.0	32471.22	Not reported	Not reported	Not reported
Placebo + BSC	286.3	425.45	Not reported	Not reported	Not reported

Week 84

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	45
Placebo + BSC	14

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	4379.9	28302.84	Not reported	Not reported	Not reported
Placebo + BSC	175.4	575.98	Not reported	Not reported	Not reported

Week 88

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	36
Placebo + BSC	11

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	571.2	2694.44	Not reported	Not reported	Not reported
Placebo + BSC	-9.4	473.66	Not reported	Not reported	Not reported

Week 92

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	30
Placebo + BSC	10

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	765.5	2913.15	Not reported	Not reported	Not reported
Placebo + BSC	63.7	477.53	Not reported	Not reported	Not reported

Week 96

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	24
Placebo + BSC	10

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	984.6	3379.28	Not reported	Not reported	Not reported
Placebo + BSC	146.5	468.24	Not reported	Not reported	Not reported

Week 100

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	22
Placebo + BSC	6

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	935.3	2961.60	Not reported	Not reported	Not reported
Placebo + BSC	-12.7	399.25	Not reported	Not reported	Not reported

Week 104

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	15
Placebo + BSC	6

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	1466.4	4257.03	Not reported	Not reported	Not reported
Placebo + BSC	-21.7	285.99	Not reported	Not reported	Not reported

Week 108

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	12
Placebo + BSC	6

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	2245.8	6077.99	Not reported	Not reported	Not reported
Placebo + BSC	215.9	293.87	Not reported	Not reported	Not reported

Week 112

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	12
Placebo + BSC	4

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	2817.0	7786.28	Not reported	Not reported	Not reported
Placebo + BSC	514.5	661.80	Not reported	Not reported	Not reported

Week 116

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	6
Placebo + BSC	4

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	2951.8	6745.06	Not reported	Not reported	Not reported
Placebo + BSC	99.6	92.91	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
2306.70
value
434.8
group Id
OG001
spread
9083.39
value
1154.3
denoms
counts
group Id
OG000
value
164
group Id
OG001
value
90
units
Participants
title
Week 4
categories
measurements
group Id
OG000
spread
2550.65
value
162.3
group Id
OG001
spread
19956.90
value
2697.6
denoms
counts
group Id
OG000
value
156
group Id
OG001
value
88
units
Participants
title
Week 8
categories
measurements
group Id
OG000
spread
2401.78
value
396.7
group Id
OG001
spread
3322.13
value
1176.0
denoms
counts
group Id
OG000
value
143
group Id
OG001
value
75
units
Participants
title
Week 12
categories
measurements
group Id
OG000
spread
2946.76
value
263.5
group Id
OG001
spread
4825.78
value
1450.4
denoms
counts
group Id
OG000
value
141
group Id
OG001
value
62
units
Participants
title
Week 16
categories
measurements
group Id
OG000
spread
2464.47
value
162.1
group Id
OG001
spread
12653.42
value
3640.1
denoms
counts
group Id
OG000
value
131
group Id
OG001
value
51
units
Participants
title
Week 20
categories
measurements
group Id
OG000
spread
3487.27
value
253.2
group Id
OG001
spread
5399.98
value
1783.9
denoms
counts
group Id
OG000
value
119
group Id
OG001
value
39
units
Participants
title
Week 24
categories
measurements
group Id
OG000
spread
4861.35
value
587.2
group Id
OG001
spread
5701.70
value
1350.3
denoms
counts
group Id
OG000
value
112
group Id
OG001
value
35
units
Participants
title
Week 28
categories
measurements
group Id
OG000
spread
6102.61
value
508.5
group Id
OG001
spread
6362.83
value
2000.7
denoms
counts
group Id
OG000
value
109
group Id
OG001
value
31
units
Participants
title
Week 32
categories
measurements
group Id
OG000
spread
4905.17
value
94.7
group Id
OG001
spread
383.93
value
180.9
denoms
counts
group Id
OG000
value
97
group Id
OG001
value
26
units
Participants
title
Week 36
categories
measurements
group Id
OG000
spread
6180.67
value
511.4
group Id
OG001
spread
403.30
value
207.6
denoms
counts
group Id
OG000
value
87
group Id
OG001
value
24
units
Participants
title
Week 40
categories
measurements
group Id
OG000
spread
4173.44
value
552.8
group Id
OG001
spread
328.02
value
140.6
denoms
counts
group Id
OG000
value
86
group Id
OG001
value
23
units
Participants
title
Week 44
categories
measurements
group Id
OG000
spread
8718.92
value
1326.2
group Id
OG001
spread
326.69
value
129.0
denoms
counts
group Id
OG000
value
77
group Id
OG001
value
23
units
Participants
title
Week 48

denoms

counts
group Id
OG000
value
205
group Id
OG001
value
97
units
Participants

description

CgA is a potential biomarker for tumor response. Blood samples were collected for assessment of CgA levels. Change from Baseline at a particular visit was calculated as the CgA level at that visit minus Baseline.

dispersion Type

Standard Deviation

groups

description
Participants received everolimus 10 mg once daily BSC throughout the study
id
OG000
title
Everolimus + BSC
description
Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
id
OG001
title
Placebo + BSC

param Type

MEAN

population Description

The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization. Number analyzed signified number of participants with available data for this outcome measure at specified timepoints.

reporting Status

POSTED

time Frame

From baseline (every 4 weeks) up to 116 weeks

title

Change From Baseline in Chromogranin A (CgA) Levels

type

SECONDARY

unit Of Measure

microgram/liter (ug/L)

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

Preserved source evidence · Not medical advice