NCT02504372 · BASELINE

Baseline characteristics

Study of Pembrolizumab (MK-3475) vs Placebo for Participants With Non-small Cell Lung Cancer After Resection With or Without Standard Adjuvant Therapy (MK-3475-091/KEYNOTE-091) · Source last updated 2026-03-17

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

denoms

counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants

groups

description
Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.
id
BG000
title
Pembrolizumab
description
Participants received placebo, IV, every 3 weeks, for one year.
id
BG001
title
Placebo
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
8.5
value
64.1
group Id
BG001
spread
8.4
value
64.5
group Id
BG002
spread
8.4
value
64.3
denoms
counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
Years
classes
categories
measurements
group Id
BG000
value
189
group Id
BG001
value
184
group Id
BG002
value
373
title
Female
measurements
group Id
BG000
value
401
group Id
BG001
value
403
group Id
BG002
value
804
title
Male
denoms
counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
107
group Id
BG001
value
107
group Id
BG002
value
214
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
3
title
Black or African American
measurements
group Id
BG000
value
450
group Id
BG001
value
455
group Id
BG002
value
905
title
White
measurements
group Id
BG000
value
10
group Id
BG001
value
3
group Id
BG002
value
13
title
More than one race
measurements
group Id
BG000
value
22
group Id
BG001
value
19
group Id
BG002
value
41
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
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
85
group Id
BG001
value
87
group Id
BG002
value
172
title
Stage IB
measurements
group Id
BG000
value
330
group Id
BG001
value
338
group Id
BG002
value
668
title
Stage II
measurements
group Id
BG000
value
175
group Id
BG001
value
160
group Id
BG002
value
335
title
Stage IIIA
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Stage IV
denoms
counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants
description
Participants were classified per American Joint Committee on Cancer Manual Edition 7th (AJCC V7) based on TNM classification where T refers to size and extent of primary tumor and if it invaded nearby tissue, N refers to location of nearby lymph nodes that have cancer and M refers to distant metastasis (spread of cancer to other parts). In stages I, II and III the cancer is present. The higher the number, the larger the cancer tumor and the more it has spread into nearby tissues. In stage IV, the cancer has spread to distant parts of the body. Higher numbers mean the cancer is more advanced.
param Type
COUNT_OF_PARTICIPANTS
title
Disease Stage at Baseline
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
233
group Id
BG001
value
232
group Id
BG002
value
465
title
TPS <1%
measurements
group Id
BG000
value
189
group Id
BG001
value
190
group Id
BG002
value
379
title
TPS 1-49%
measurements
group Id
BG000
value
168
group Id
BG001
value
165
group Id
BG002
value
333
title
TPS ≥50%
denoms
counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants
description
Participants were assessed for their PD-L1 tumor expression status by immunohistochemistry assay using tumor tissue from a biopsy. Participants with a tumor proportion score (TPS) were classified as follows: \<1% = PD-L1 negative, 1-49% = PD-L1 weakly positive; and ≥50% = PD-L1 strongly positive.
param Type
COUNT_OF_PARTICIPANTS
title
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status at Baseline
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
506
group Id
BG001
value
504
group Id
BG002
value
1010
title
Yes
measurements
group Id
BG000
value
84
group Id
BG001
value
83
group Id
BG002
value
167
title
No
denoms
counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants
description
Participants were classified per receiving of standard adjuvant chemotherapy at baseline: Yes or No.
param Type
COUNT_OF_PARTICIPANTS
title
Adjuvant Chemotherapy at Baseline
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
303
group Id
BG001
value
301
group Id
BG002
value
604
title
Western Europe
measurements
group Id
BG000
value
116
group Id
BG001
value
113
group Id
BG002
value
229
title
Eastern Europe
measurements
group Id
BG000
value
65
group Id
BG001
value
68
group Id
BG002
value
133
title
Rest of the World
measurements
group Id
BG000
value
106
group Id
BG001
value
105
group Id
BG002
value
211
title
Asia
denoms
counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants
description
Participants were classified based on their geographic region as those from: Western Europe, Easter Europe, Asia and Rest of the world.
param Type
COUNT_OF_PARTICIPANTS
title
Geographic region
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
192
group Id
BG001
value
224
group Id
BG002
value
416
title
Squamous
measurements
group Id
BG000
value
398
group Id
BG001
value
363
group Id
BG002
value
761
title
Non-squamous
denoms
counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants
description
Participants were classified according to tumor histology: Squamous or Non-squamous. The tumor histology determined potential treatment regimen.
param Type
COUNT_OF_PARTICIPANTS
title
Tumor Histology
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
87
group Id
BG001
value
66
group Id
BG002
value
153
title
Never smoker
measurements
group Id
BG000
value
428
group Id
BG001
value
431
group Id
BG002
value
859
title
Former smoker
measurements
group Id
BG000
value
75
group Id
BG001
value
90
group Id
BG002
value
165
title
Current smoker
denoms
counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants
description
Participants were classified per centers of disease control and prevention (CDC) as: Never smoker (smoked fewer than 100 cigarettes in his/her lifetime), former smoker (smoked at least 100 cigarettes in his or her lifetime but who had quit smoking at the time of interview. and current smoker (smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes) at baseline.
param Type
COUNT_OF_PARTICIPANTS
title
Smoking status
unit Of Measure
Participants

population Description

All randomized participants. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.

Complete source fields

denoms

counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants

groups

description
Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.
id
BG000
title
Pembrolizumab
description
Participants received placebo, IV, every 3 weeks, for one year.
id
BG001
title
Placebo
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
8.5
value
64.1
group Id
BG001
spread
8.4
value
64.5
group Id
BG002
spread
8.4
value
64.3
denoms
counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
Years
classes
categories
measurements
group Id
BG000
value
189
group Id
BG001
value
184
group Id
BG002
value
373
title
Female
measurements
group Id
BG000
value
401
group Id
BG001
value
403
group Id
BG002
value
804
title
Male
denoms
counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
107
group Id
BG001
value
107
group Id
BG002
value
214
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
3
title
Black or African American
measurements
group Id
BG000
value
450
group Id
BG001
value
455
group Id
BG002
value
905
title
White
measurements
group Id
BG000
value
10
group Id
BG001
value
3
group Id
BG002
value
13
title
More than one race
measurements
group Id
BG000
value
22
group Id
BG001
value
19
group Id
BG002
value
41
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
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
85
group Id
BG001
value
87
group Id
BG002
value
172
title
Stage IB
measurements
group Id
BG000
value
330
group Id
BG001
value
338
group Id
BG002
value
668
title
Stage II
measurements
group Id
BG000
value
175
group Id
BG001
value
160
group Id
BG002
value
335
title
Stage IIIA
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Stage IV
denoms
counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants
description
Participants were classified per American Joint Committee on Cancer Manual Edition 7th (AJCC V7) based on TNM classification where T refers to size and extent of primary tumor and if it invaded nearby tissue, N refers to location of nearby lymph nodes that have cancer and M refers to distant metastasis (spread of cancer to other parts). In stages I, II and III the cancer is present. The higher the number, the larger the cancer tumor and the more it has spread into nearby tissues. In stage IV, the cancer has spread to distant parts of the body. Higher numbers mean the cancer is more advanced.
param Type
COUNT_OF_PARTICIPANTS
title
Disease Stage at Baseline
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
233
group Id
BG001
value
232
group Id
BG002
value
465
title
TPS <1%
measurements
group Id
BG000
value
189
group Id
BG001
value
190
group Id
BG002
value
379
title
TPS 1-49%
measurements
group Id
BG000
value
168
group Id
BG001
value
165
group Id
BG002
value
333
title
TPS ≥50%
denoms
counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants
description
Participants were assessed for their PD-L1 tumor expression status by immunohistochemistry assay using tumor tissue from a biopsy. Participants with a tumor proportion score (TPS) were classified as follows: \<1% = PD-L1 negative, 1-49% = PD-L1 weakly positive; and ≥50% = PD-L1 strongly positive.
param Type
COUNT_OF_PARTICIPANTS
title
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status at Baseline
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
506
group Id
BG001
value
504
group Id
BG002
value
1010
title
Yes
measurements
group Id
BG000
value
84
group Id
BG001
value
83
group Id
BG002
value
167
title
No
denoms
counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants
description
Participants were classified per receiving of standard adjuvant chemotherapy at baseline: Yes or No.
param Type
COUNT_OF_PARTICIPANTS
title
Adjuvant Chemotherapy at Baseline
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
303
group Id
BG001
value
301
group Id
BG002
value
604
title
Western Europe
measurements
group Id
BG000
value
116
group Id
BG001
value
113
group Id
BG002
value
229
title
Eastern Europe
measurements
group Id
BG000
value
65
group Id
BG001
value
68
group Id
BG002
value
133
title
Rest of the World
measurements
group Id
BG000
value
106
group Id
BG001
value
105
group Id
BG002
value
211
title
Asia
denoms
counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants
description
Participants were classified based on their geographic region as those from: Western Europe, Easter Europe, Asia and Rest of the world.
param Type
COUNT_OF_PARTICIPANTS
title
Geographic region
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
192
group Id
BG001
value
224
group Id
BG002
value
416
title
Squamous
measurements
group Id
BG000
value
398
group Id
BG001
value
363
group Id
BG002
value
761
title
Non-squamous
denoms
counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants
description
Participants were classified according to tumor histology: Squamous or Non-squamous. The tumor histology determined potential treatment regimen.
param Type
COUNT_OF_PARTICIPANTS
title
Tumor Histology
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
87
group Id
BG001
value
66
group Id
BG002
value
153
title
Never smoker
measurements
group Id
BG000
value
428
group Id
BG001
value
431
group Id
BG002
value
859
title
Former smoker
measurements
group Id
BG000
value
75
group Id
BG001
value
90
group Id
BG002
value
165
title
Current smoker
denoms
counts
group Id
BG000
value
590
group Id
BG001
value
587
group Id
BG002
value
1177
units
Participants
description
Participants were classified per centers of disease control and prevention (CDC) as: Never smoker (smoked fewer than 100 cigarettes in his/her lifetime), former smoker (smoked at least 100 cigarettes in his or her lifetime but who had quit smoking at the time of interview. and current smoker (smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes) at baseline.
param Type
COUNT_OF_PARTICIPANTS
title
Smoking status
unit Of Measure
Participants

population Description

All randomized participants. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.

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Preserved source evidence · Not medical advice