NCT01265433 · BASELINE

Baseline characteristics

Galinpepimut-S (WT-1 Analog Peptide) Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy · Source last updated 2024-10-09

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

denoms

counts
group Id
BG000
value
20
group Id
BG001
value
21
group Id
BG002
value
41
units
Participants

groups

description
Galinpepimut-s + Montanide + GM-CSF
id
BG000
title
Galinpepimut-S
description
Montanide + GM-CSF
id
BG001
title
Control
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
34
upper Limit
84
value
70
group Id
BG001
lower Limit
48
upper Limit
79
value
67
group Id
BG002
lower Limit
34
upper Limit
84
value
68
denoms
counts
group Id
BG000
value
20
group Id
BG001
value
21
group Id
BG002
value
41
units
Participants
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
title
Female
measurements
group Id
BG000
value
17
group Id
BG001
value
18
group Id
BG002
value
35
title
Male
denoms
counts
group Id
BG000
value
20
group Id
BG001
value
21
group Id
BG002
value
41
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG002
value
0
denoms
counts
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Race and Ethnicity were not collected from any participant.
title
Race and Ethnicity Not Collected
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
3
group Id
BG002
value
4
title
70%
measurements
group Id
BG000
value
7
group Id
BG001
value
12
group Id
BG002
value
19
title
80%
measurements
group Id
BG000
value
11
group Id
BG001
value
6
group Id
BG002
value
17
title
90%
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
100%
denoms
counts
group Id
BG000
value
20
group Id
BG001
value
21
group Id
BG002
value
41
units
Participants
description
The Karnofsky Performance Scale Index classifies the patient's functional impairment, used to assess the prognosis in individual patients. The lower the score, the worse the prognosis. 100: Able to carry on normal activity; no special care needed. No evidence of disease 90: Able to carry on normal activity; minor signs/symptoms of disease 80: Normal activity with effort; some signs/symptoms of disease 70: Cares for self; unable to carry on normal activity 60: Requires occasional assistance, but able to care of personal needs 50: Requires considerable assistance and frequent medical care
param Type
COUNT_OF_PARTICIPANTS
title
Karnofsky performance status at enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
13
group Id
BG002
value
25
title
Former
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Current
measurements
group Id
BG000
value
8
group Id
BG001
value
8
group Id
BG002
value
16
title
Never
denoms
counts
group Id
BG000
value
20
group Id
BG001
value
21
group Id
BG002
value
41
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Smoking status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
21
group Id
BG002
value
39
title
Epithelioid
measurements
group Id
BG000
value
2
group Id
BG001
value
0
group Id
BG002
value
2
title
Mixed
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Sarcomatoid
denoms
counts
group Id
BG000
value
20
group Id
BG001
value
21
group Id
BG002
value
41
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Histology
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
20
group Id
BG001
value
21
group Id
BG002
value
41
units
Participants

groups

description
Galinpepimut-s + Montanide + GM-CSF
id
BG000
title
Galinpepimut-S
description
Montanide + GM-CSF
id
BG001
title
Control
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
34
upper Limit
84
value
70
group Id
BG001
lower Limit
48
upper Limit
79
value
67
group Id
BG002
lower Limit
34
upper Limit
84
value
68
denoms
counts
group Id
BG000
value
20
group Id
BG001
value
21
group Id
BG002
value
41
units
Participants
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
title
Female
measurements
group Id
BG000
value
17
group Id
BG001
value
18
group Id
BG002
value
35
title
Male
denoms
counts
group Id
BG000
value
20
group Id
BG001
value
21
group Id
BG002
value
41
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG002
value
0
denoms
counts
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Race and Ethnicity were not collected from any participant.
title
Race and Ethnicity Not Collected
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
3
group Id
BG002
value
4
title
70%
measurements
group Id
BG000
value
7
group Id
BG001
value
12
group Id
BG002
value
19
title
80%
measurements
group Id
BG000
value
11
group Id
BG001
value
6
group Id
BG002
value
17
title
90%
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
100%
denoms
counts
group Id
BG000
value
20
group Id
BG001
value
21
group Id
BG002
value
41
units
Participants
description
The Karnofsky Performance Scale Index classifies the patient's functional impairment, used to assess the prognosis in individual patients. The lower the score, the worse the prognosis. 100: Able to carry on normal activity; no special care needed. No evidence of disease 90: Able to carry on normal activity; minor signs/symptoms of disease 80: Normal activity with effort; some signs/symptoms of disease 70: Cares for self; unable to carry on normal activity 60: Requires occasional assistance, but able to care of personal needs 50: Requires considerable assistance and frequent medical care
param Type
COUNT_OF_PARTICIPANTS
title
Karnofsky performance status at enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
13
group Id
BG002
value
25
title
Former
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Current
measurements
group Id
BG000
value
8
group Id
BG001
value
8
group Id
BG002
value
16
title
Never
denoms
counts
group Id
BG000
value
20
group Id
BG001
value
21
group Id
BG002
value
41
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Smoking status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
21
group Id
BG002
value
39
title
Epithelioid
measurements
group Id
BG000
value
2
group Id
BG001
value
0
group Id
BG002
value
2
title
Mixed
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Sarcomatoid
denoms
counts
group Id
BG000
value
20
group Id
BG001
value
21
group Id
BG002
value
41
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Histology
unit Of Measure
Participants

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Preserved source evidence · Not medical advice