NCT00122460 · BASELINE

Baseline characteristics

Cetuximab (Erbitux) in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (EXTREME) · Source last updated 2014-07-23

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

denoms

counts
group Id
BG000
value
222
group Id
BG001
value
220
group Id
BG002
value
442
units
Participants

groups

description
Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
id
BG000
title
Cetuximab Plus Chemotherapy
description
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
id
BG001
title
Chemotherapy Alone
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
183
group Id
BG001
value
182
group Id
BG002
value
365
title
Between 18 and 65 years
measurements
group Id
BG000
value
39
group Id
BG001
value
38
group Id
BG002
value
77
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
8.0
value
57.1
group Id
BG001
spread
8.7
value
56.7
group Id
BG002
spread
8.3
value
56.9
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
25
group Id
BG001
value
18
group Id
BG002
value
43
title
Female
measurements
group Id
BG000
value
197
group Id
BG001
value
202
group Id
BG002
value
399
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
6
group Id
BG002
value
9
title
Portugal
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
Slovakia
categories
measurements
group Id
BG000
value
38
group Id
BG001
value
41
group Id
BG002
value
79
title
Spain
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
16
group Id
BG002
value
34
title
Ukraine
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
10
group Id
BG002
value
14
title
Austria
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
7
group Id
BG002
value
16
title
Russian Federation
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
9
title
United Kingdom
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
4
group Id
BG002
value
8
title
Switzerland
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
12
group Id
BG002
value
26
title
Italy
categories
measurements
group Id
BG000
value
45
group Id
BG001
value
31
group Id
BG002
value
76
title
France
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
9
title
Czech Republic
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
24
group Id
BG002
value
43
title
Hungary
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants

Complete source fields

denoms

counts
group Id
BG000
value
222
group Id
BG001
value
220
group Id
BG002
value
442
units
Participants

groups

description
Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
id
BG000
title
Cetuximab Plus Chemotherapy
description
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
id
BG001
title
Chemotherapy Alone
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
183
group Id
BG001
value
182
group Id
BG002
value
365
title
Between 18 and 65 years
measurements
group Id
BG000
value
39
group Id
BG001
value
38
group Id
BG002
value
77
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
8.0
value
57.1
group Id
BG001
spread
8.7
value
56.7
group Id
BG002
spread
8.3
value
56.9
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
25
group Id
BG001
value
18
group Id
BG002
value
43
title
Female
measurements
group Id
BG000
value
197
group Id
BG001
value
202
group Id
BG002
value
399
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
6
group Id
BG002
value
9
title
Portugal
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
Slovakia
categories
measurements
group Id
BG000
value
38
group Id
BG001
value
41
group Id
BG002
value
79
title
Spain
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
16
group Id
BG002
value
34
title
Ukraine
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
10
group Id
BG002
value
14
title
Austria
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
7
group Id
BG002
value
16
title
Russian Federation
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
9
title
United Kingdom
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
4
group Id
BG002
value
8
title
Switzerland
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
12
group Id
BG002
value
26
title
Italy
categories
measurements
group Id
BG000
value
45
group Id
BG001
value
31
group Id
BG002
value
76
title
France
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
9
title
Czech Republic
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
24
group Id
BG002
value
43
title
Hungary
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants

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

Preserved source evidence · Not medical advice