Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0006

source section id

NCT03765918-om-0006

source outcome index

6

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Scale Combined Score at Week 4

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 4

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0007

source section id

NCT03765918-om-0007

source outcome index

7

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 4

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 4

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0008

source section id

NCT03765918-om-0008

source outcome index

8

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QOL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 4

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 4

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0009

source section id

NCT03765918-om-0009

source outcome index

9

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 6

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 6

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0010

source section id

NCT03765918-om-0010

source outcome index

10

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 6

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 6

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0011

source section id

NCT03765918-om-0011

source outcome index

11

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 6

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 6

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0012

source section id

NCT03765918-om-0012

source outcome index

12

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 25

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants was presented.

time frame

Baseline and Week 25

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0013

source section id

NCT03765918-om-0013

source outcome index

13

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 25

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 was presented.

time frame

Baseline and Week 25

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0014

source section id

NCT03765918-om-0014

source outcome index

14

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 25

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 was presented.

time frame

Baseline and Week 25

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0015

source section id

NCT03765918-om-0015

source outcome index

15

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 51

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants was presented.

time frame

Baseline and Week 51

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0016

source section id

NCT03765918-om-0016

source outcome index

16

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 51

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 was presented.

time frame

Baseline and Week 51

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0017

source section id

NCT03765918-om-0017

source outcome index

17

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 51

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 was presented.

time frame

Baseline and Week 51

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0018

source section id

NCT03765918-om-0018

source outcome index

18

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 4

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 4

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0019

source section id

NCT03765918-om-0019

source outcome index

19

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 4

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 4

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0020

source section id

NCT03765918-om-0020

source outcome index

20

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 4

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 4

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0021

source section id

NCT03765918-om-0021

source outcome index

21

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 6

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 6

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0022

source section id

NCT03765918-om-0022

source outcome index

22

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 6

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 6

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0023

source section id

NCT03765918-om-0023

source outcome index

23

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 6

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 6

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0024

source section id

NCT03765918-om-0024

source outcome index

24

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 25

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants was presented.

time frame

Baseline and Week 25

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0025

source section id

NCT03765918-om-0025

source outcome index

25

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 25

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.

time frame

Baseline and Week 25

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0026

source section id

NCT03765918-om-0026

source outcome index

26

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 25

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.

time frame

Baseline and Week 25

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0027

source section id

NCT03765918-om-0027

source outcome index

27

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 51

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants was presented.

time frame

Baseline and Week 51

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0028

source section id

NCT03765918-om-0028

source outcome index

28

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 51

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.

time frame

Baseline and Week 51

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0029

source section id

NCT03765918-om-0029

source outcome index

29

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 51

measure definition

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.

time frame

Baseline and Week 51

analysis role

secondary

reporting status

POSTED

higher is better

1

direction quote

higher score indicated a better

population note

All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0030

source section id

NCT03765918-om-0030

source outcome index

30

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-Head and Neck Module 35 [H&N35] (Items 35-38) Swallowing Combined Score at Week 4

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 4

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0031

source section id

NCT03765918-om-0031

source outcome index

31

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 4

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 4

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0032

source section id

NCT03765918-om-0032

source outcome index

32

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 4

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 4

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0033

source section id

NCT03765918-om-0033

source outcome index

33

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 6

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 6

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0034

source section id

NCT03765918-om-0034

source outcome index

34

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 6

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 6

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0035

source section id

NCT03765918-om-0035

source outcome index

35

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 6

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 6

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0036

source section id

NCT03765918-om-0036

source outcome index

36

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 25

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants was presented.

time frame

Baseline and Week 25

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 25.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0037

source section id

NCT03765918-om-0037

source outcome index

37

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 25

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.

time frame

Baseline and Week 25

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 25.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0038

source section id

NCT03765918-om-0038

source outcome index

38

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 25

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.

time frame

Baseline and Week 25

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 25.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0039

source section id

NCT03765918-om-0039

source outcome index

39

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 51

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants was presented.

time frame

Baseline and Week 51

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 51.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0040

source section id

NCT03765918-om-0040

source outcome index

40

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 51

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.

time frame

Baseline and Week 51

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 51.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0041

source section id

NCT03765918-om-0041

source outcome index

41

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 51

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.

time frame

Baseline and Week 51

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 51.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0042

source section id

NCT03765918-om-0042

source outcome index

42

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 4

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 4

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0043

source section id

NCT03765918-om-0043

source outcome index

43

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 4

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 4

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0044

source section id

NCT03765918-om-0044

source outcome index

44

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 4

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 4

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0045

source section id

NCT03765918-om-0045

source outcome index

45

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 6

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 6

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0046

source section id

NCT03765918-om-0046

source outcome index

46

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 6

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 6

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0047

source section id

NCT03765918-om-0047

source outcome index

47

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 6

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 6

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0048

source section id

NCT03765918-om-0048

source outcome index

48

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 25

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants was presented.

time frame

Baseline and Week 25

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 25.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0049

source section id

NCT03765918-om-0049

source outcome index

49

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 25

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.

time frame

Baseline and Week 25

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 25.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0050

source section id

NCT03765918-om-0050

source outcome index

50

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 25

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.

time frame

Baseline and Week 25

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 25.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0051

source section id

NCT03765918-om-0051

source outcome index

51

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 51

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants was presented.

time frame

Baseline and Week 51

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 51.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0052

source section id

NCT03765918-om-0052

source outcome index

52

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 51

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.

time frame

Baseline and Week 51

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 51.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0053

source section id

NCT03765918-om-0053

source outcome index

53

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 51

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.

time frame

Baseline and Week 51

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 51.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0054

source section id

NCT03765918-om-0054

source outcome index

54

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 4

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 4

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0055

source section id

NCT03765918-om-0055

source outcome index

55

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 4

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 4

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0056

source section id

NCT03765918-om-0056

source outcome index

56

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 4

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 4

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0057

source section id

NCT03765918-om-0057

source outcome index

57

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 6

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 6

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0058

source section id

NCT03765918-om-0058

source outcome index

58

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 6

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 6

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0059

source section id

NCT03765918-om-0059

source outcome index

59

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 6

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.

time frame

Baseline and Week 6

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0060

source section id

NCT03765918-om-0060

source outcome index

60

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 25

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants was presented.

time frame

Baseline and Week 25

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 25.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0061

source section id

NCT03765918-om-0061

source outcome index

61

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 25

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.

time frame

Baseline and Week 25

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 25.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0062

source section id

NCT03765918-om-0062

source outcome index

62

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 25

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.

time frame

Baseline and Week 25

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 25.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0063

source section id

NCT03765918-om-0063

source outcome index

63

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 51

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants was presented.

time frame

Baseline and Week 51

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 51.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0064

source section id

NCT03765918-om-0064

source outcome index

64

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 51

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.

time frame

Baseline and Week 51

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 51.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id

clinical-indications-draft-1

disease state id

ds-head-and-neck-neoplasm

nct id

NCT03765918

qol key

qol-0065

source section id

NCT03765918-om-0065

source outcome index

65

instrument

EORTC QLQ

instrument basis

matched 'eortc' in the study's own wording

scale title

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 51

measure definition

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.

time frame

Baseline and Week 51

analysis role

secondary

reporting status

POSTED

higher is better

Source null

direction quote

Source null

population note

All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 51.

curation status

draft

reviewed by

Source null

reviewed at

Source null

created at

2026-09-10T00:00:00Z