Number of Participants With Post-baseline Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events for Head and Neck (PRO-CTCAE H&N) Scores >= 3
Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer · Source last updated 2026-07-20
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
End of treatment (approximately 6 weeks after baseline); and 3, 6, and 12 months after end of treatment (approximately 4.5, 7.5, and 13.5 months after baseline).
What was measured
PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials, asking the patient about experience over the last seven days. Scores may reflect worst severity of the symptom (0=None, 1=Mild, 2=Moderate, 3=Severe, and 4=Very severe), frequency of the symptom (0=Never, 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost constantly), or the symptom's interference with one's "usual or daily activities" (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). The symptom row title will indicate "Severity", "Frequency", or "Interference". All scores are compared between arms; statistical analysis results are entered for p-values \< 0.05.
Analysis population: Eligible participants enrolled in the QOL substudy who received protocol treatment and had data.
Groups in this outcome
IMRT + Cisplatin
Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin
Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT
IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
IMRT + Cetuximab
Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab
Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks
IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
IMRT + Cisplatin
176
IMRT + Cetuximab
172
Reported measurements
Discouraged Feelings Frequency
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
17
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
25
Not reported
Not reported
Not reported
Not reported
Discouraged Feelings Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
13
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
13
Not reported
Not reported
Not reported
Not reported
Discouraged Feelings Interference
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
13
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
18
Not reported
Not reported
Not reported
Not reported
Mouth Sores Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
96
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
84
Not reported
Not reported
Not reported
Not reported
Mouth Sores Interference
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
63
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
82
Not reported
Not reported
Not reported
Not reported
Hair Loss Presence
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
10
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
14
Not reported
Not reported
Not reported
Not reported
Difficulty Swallowing Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
116
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
80
Not reported
Not reported
Not reported
Not reported
Vomiting Frequency
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
22
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
15
Not reported
Not reported
Not reported
Not reported
Vomiting Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
25
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
17
Not reported
Not reported
Not reported
Not reported
Heartburn Frequency
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
26
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
22
Not reported
Not reported
Not reported
Not reported
Heartburn Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
16
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
11
Not reported
Not reported
Not reported
Not reported
Fatigue Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
67
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
61
Not reported
Not reported
Not reported
Not reported
Fatigue Interference
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
77
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
69
Not reported
Not reported
Not reported
Not reported
Constipation Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
34
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
32
Not reported
Not reported
Not reported
Not reported
Skin Radiation Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
46
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
57
Not reported
Not reported
Not reported
Not reported
Ringing In Ears Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
54
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
7
Not reported
Not reported
Not reported
Not reported
Nausea Frequency
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
56
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
38
Not reported
Not reported
Not reported
Not reported
Nausea Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
34
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
26
Not reported
Not reported
Not reported
Not reported
Itching Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
18
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
15
Not reported
Not reported
Not reported
Not reported
Dry Skin Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
21
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
28
Not reported
Not reported
Not reported
Not reported
Decreased Appetite Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
75
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
78
Not reported
Not reported
Not reported
Not reported
Decreased Appetite Interference
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
47
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
53
Not reported
Not reported
Not reported
Not reported
Dry Mouth Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
168
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
160
Not reported
Not reported
Not reported
Not reported
Hoarseness Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
69
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
50
Not reported
Not reported
Not reported
Not reported
Pain Frequency
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
142
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
113
Not reported
Not reported
Not reported
Not reported
Pain Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
98
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
64
Not reported
Not reported
Not reported
Not reported
Pain Interference
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
64
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
53
Not reported
Not reported
Not reported
Not reported
Taste Change Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
159
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
148
Not reported
Not reported
Not reported
Not reported
Diarrhea Frequency
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
14
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
12
Not reported
Not reported
Not reported
Not reported
Nail Loss Presence
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
0
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
0
Not reported
Not reported
Not reported
Not reported
Acne Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
5
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
20
Not reported
Not reported
Not reported
Not reported
Numbness And Tingling Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
8
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
6
Not reported
Not reported
Not reported
Not reported
Numbness And Tingling Interference
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
6
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
3
Not reported
Not reported
Not reported
Not reported
Cough Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
36
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
15
Not reported
Not reported
Not reported
Not reported
Cough Interference
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
23
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
11
Not reported
Not reported
Not reported
Not reported
Rash Presence
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
0
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
0
Not reported
Not reported
Not reported
Not reported
Anxiety Frequency
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
30
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
36
Not reported
Not reported
Not reported
Not reported
Anxiety Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
13
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
20
Not reported
Not reported
Not reported
Not reported
Anxiety Interference
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
14
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
17
Not reported
Not reported
Not reported
Not reported
Insomnia Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
54
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
38
Not reported
Not reported
Not reported
Not reported
Insomnia Interference
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
45
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
31
Not reported
Not reported
Not reported
Not reported
Sad Feelings Frequency
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
32
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
30
Not reported
Not reported
Not reported
Not reported
Sad Feelings Severity
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
18
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
15
Not reported
Not reported
Not reported
Not reported
Sad Feelings Interference
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
IMRT + Cisplatin
16
Not reported
Not reported
Not reported
Not reported
IMRT + Cetuximab
17
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
25
title
Discouraged Feelings Frequency
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
13
title
Discouraged Feelings Severity
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
18
title
Discouraged Feelings Interference
categories
measurements
group Id
OG000
value
96
group Id
OG001
value
84
title
Mouth Sores Severity
categories
measurements
group Id
OG000
value
63
group Id
OG001
value
82
title
Mouth Sores Interference
categories
measurements
group Id
OG000
value
10
group Id
OG001
value
14
title
Hair Loss Presence
categories
measurements
group Id
OG000
value
116
group Id
OG001
value
80
title
Difficulty Swallowing Severity
categories
measurements
group Id
OG000
value
22
group Id
OG001
value
15
title
Vomiting Frequency
categories
measurements
group Id
OG000
value
25
group Id
OG001
value
17
title
Vomiting Severity
categories
measurements
group Id
OG000
value
26
group Id
OG001
value
22
title
Heartburn Frequency
categories
measurements
group Id
OG000
value
16
group Id
OG001
value
11
title
Heartburn Severity
categories
measurements
group Id
OG000
value
67
group Id
OG001
value
61
title
Fatigue Severity
denoms
counts
group Id
OG000
value
176
group Id
OG001
value
172
units
Participants
description
PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials, asking the patient about experience over the last seven days. Scores may reflect worst severity of the symptom (0=None, 1=Mild, 2=Moderate, 3=Severe, and 4=Very severe), frequency of the symptom (0=Never, 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost constantly), or the symptom's interference with one's "usual or daily activities" (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). The symptom row title will indicate "Severity", "Frequency", or "Interference". All scores are compared between arms; statistical analysis results are entered for p-values \< 0.05.
groups
description
Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin
Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT
IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
id
OG000
title
IMRT + Cisplatin
description
Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab
Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks
IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
id
OG001
title
IMRT + Cetuximab
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible participants enrolled in the QOL substudy who received protocol treatment and had data.
reporting Status
POSTED
time Frame
End of treatment (approximately 6 weeks after baseline); and 3, 6, and 12 months after end of treatment (approximately 4.5, 7.5, and 13.5 months after baseline).
title
Number of Participants With Post-baseline Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events for Head and Neck (PRO-CTCAE H&N) Scores >= 3
Triangle