NCT02545907 · BASELINE

Baseline characteristics

A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis · Source last updated 2021-04-15

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

denoms

counts
group Id
BG000
value
3
group Id
BG001
value
7
group Id
BG002
value
10
units
Participants

groups

description
Participants received carfilzomib (K), thalidomide (T), and dexamethasone (D) in combination. The dose of thalidomide will be 50mg/day. The dose of dexamethasone will be 20mg on Day 1, 8, and 15. Carfilzomib will be 36mg/m\^2 administered on Day 1, 8, and 15,.
id
BG000
title
Dose Level 0 - 26/mg^2
description
Participants received carfilzomib (K), thalidomide (T), and dexamethasone (D) in combination. The dose of thalidomide will be 50mg/day. The dose of dexamethasone will be 20mg on Day 1, 8, and 15. Carfilzomib will be 36mg/m\^2 administered on Day 1, 8, and 15,.
id
BG001
title
Dose Level 1 - 45/mg^2
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
1
group Id
BG001
value
5
group Id
BG002
value
6
title
Between 18 and 65 years
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
>=65 years
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
7
group Id
BG002
value
10
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
61.0
upper Limit
75.0
value
75.0
group Id
BG001
lower Limit
51.0
upper Limit
73.0
value
62.0
group Id
BG002
lower Limit
51.0
upper Limit
75.0
value
63.0
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
7
group Id
BG002
value
10
units
Participants
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
5
group Id
BG002
value
6
title
Female
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Male
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
7
group Id
BG002
value
10
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
3
group Id
BG001
value
7
group Id
BG002
value
10
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
7
group Id
BG002
value
10
units
Participants
title
United Kingdom
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
3
group Id
BG001
value
7
group Id
BG002
value
10
units
Participants

groups

description
Participants received carfilzomib (K), thalidomide (T), and dexamethasone (D) in combination. The dose of thalidomide will be 50mg/day. The dose of dexamethasone will be 20mg on Day 1, 8, and 15. Carfilzomib will be 36mg/m\^2 administered on Day 1, 8, and 15,.
id
BG000
title
Dose Level 0 - 26/mg^2
description
Participants received carfilzomib (K), thalidomide (T), and dexamethasone (D) in combination. The dose of thalidomide will be 50mg/day. The dose of dexamethasone will be 20mg on Day 1, 8, and 15. Carfilzomib will be 36mg/m\^2 administered on Day 1, 8, and 15,.
id
BG001
title
Dose Level 1 - 45/mg^2
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
1
group Id
BG001
value
5
group Id
BG002
value
6
title
Between 18 and 65 years
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
>=65 years
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
7
group Id
BG002
value
10
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
61.0
upper Limit
75.0
value
75.0
group Id
BG001
lower Limit
51.0
upper Limit
73.0
value
62.0
group Id
BG002
lower Limit
51.0
upper Limit
75.0
value
63.0
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
7
group Id
BG002
value
10
units
Participants
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
5
group Id
BG002
value
6
title
Female
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Male
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
7
group Id
BG002
value
10
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
3
group Id
BG001
value
7
group Id
BG002
value
10
denoms
counts
group Id
BG000
value
3
group Id
BG001
value
7
group Id
BG002
value
10
units
Participants
title
United Kingdom
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice