Trial Outcomes & Findings for RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer (NCT NCT00956007)
NCT ID: NCT00956007
Last Updated: 2026-01-06
Results Overview
Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
702 participants
Primary outcome timeframe
From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
Results posted on
2026-01-06
Participant Flow
After trial registration, tissue slides from the tumor specimen were sent to the NRG Oncology biorepository for immunohistochemical analysis of epidermal growth factor receptor (EGFR) expression and (for oropharynx cancer) p16, a surrogate biomarker for human papillomavirus (HPV) positivity. From 702 registered participants, 627 were randomized.
Participant milestones
| Measure |
IMRT
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
|
IMRT Plus Cetuximab
Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
|
|---|---|---|
|
Overall Study
STARTED
|
314
|
313
|
|
Overall Study
Eligible
|
287
|
290
|
|
Overall Study
Eligible and Started Protocol Treatment
|
282
|
276
|
|
Overall Study
COMPLETED
|
287
|
290
|
|
Overall Study
NOT COMPLETED
|
27
|
23
|
Reasons for withdrawal
| Measure |
IMRT
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
|
IMRT Plus Cetuximab
Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
27
|
23
|
Baseline Characteristics
Randomized eligible participants with data
Baseline characteristics by cohort
| Measure |
IMRT
n=287 Participants
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
|
IMRT Plus Cetuximab
n=290 Participants
Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
|
Total
n=577 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=287 Participants
|
57.5 years
n=290 Participants
|
57 years
n=577 Participants
|
|
Age, Customized
≤ 49 years
|
62 Participants
n=287 Participants
|
71 Participants
n=290 Participants
|
133 Participants
n=577 Participants
|
|
Age, Customized
50 - 59 years
|
111 Participants
n=287 Participants
|
95 Participants
n=290 Participants
|
206 Participants
n=577 Participants
|
|
Age, Customized
60 - 69 years
|
91 Participants
n=287 Participants
|
101 Participants
n=290 Participants
|
192 Participants
n=577 Participants
|
|
Age, Customized
≥ 70 years
|
23 Participants
n=287 Participants
|
23 Participants
n=290 Participants
|
46 Participants
n=577 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=287 Participants
|
90 Participants
n=290 Participants
|
173 Participants
n=577 Participants
|
|
Sex: Female, Male
Male
|
204 Participants
n=287 Participants
|
200 Participants
n=290 Participants
|
404 Participants
n=577 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=287 Participants
|
16 Participants
n=290 Participants
|
38 Participants
n=577 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
256 Participants
n=287 Participants
|
268 Participants
n=290 Participants
|
524 Participants
n=577 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=287 Participants
|
6 Participants
n=290 Participants
|
15 Participants
n=577 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=287 Participants
|
2 Participants
n=290 Participants
|
2 Participants
n=577 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=287 Participants
|
12 Participants
n=290 Participants
|
20 Participants
n=577 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=287 Participants
|
0 Participants
n=290 Participants
|
1 Participants
n=577 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=287 Participants
|
21 Participants
n=290 Participants
|
42 Participants
n=577 Participants
|
|
Race (NIH/OMB)
White
|
249 Participants
n=287 Participants
|
249 Participants
n=290 Participants
|
498 Participants
n=577 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=287 Participants
|
0 Participants
n=290 Participants
|
2 Participants
n=577 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=287 Participants
|
6 Participants
n=290 Participants
|
12 Participants
n=577 Participants
|
|
Zubrod performance status
0
|
134 Participants
n=287 Participants
|
152 Participants
n=290 Participants
|
286 Participants
n=577 Participants
|
|
Zubrod performance status
1
|
153 Participants
n=287 Participants
|
138 Participants
n=290 Participants
|
291 Participants
n=577 Participants
|
|
Smoking history
Never
|
92 Participants
n=287 Participants
|
110 Participants
n=290 Participants
|
202 Participants
n=577 Participants
|
|
Smoking history
Former
|
173 Participants
n=287 Participants
|
160 Participants
n=290 Participants
|
333 Participants
n=577 Participants
|
|
Smoking history
Current
|
21 Participants
n=287 Participants
|
18 Participants
n=290 Participants
|
39 Participants
n=577 Participants
|
|
Smoking history
Unknown
|
1 Participants
n=287 Participants
|
2 Participants
n=290 Participants
|
3 Participants
n=577 Participants
|
|
Smoking history: pack-years
≤ 10
|
139 Participants
n=251 Participants • Randomized eligible participants with data
|
152 Participants
n=259 Participants • Randomized eligible participants with data
|
291 Participants
n=510 Participants • Randomized eligible participants with data
|
|
Smoking history: pack-years
> 10
|
112 Participants
n=251 Participants • Randomized eligible participants with data
|
107 Participants
n=259 Participants • Randomized eligible participants with data
|
219 Participants
n=510 Participants • Randomized eligible participants with data
|
|
Type of radiation therapy
Intensity-modulated radiation therapy (IMRT)
|
129 Participants
n=287 Participants
|
146 Participants
n=290 Participants
|
275 Participants
n=577 Participants
|
|
Type of radiation therapy
IMRT+ image-guided radiation therapy (IGRT)
|
153 Participants
n=287 Participants
|
128 Participants
n=290 Participants
|
281 Participants
n=577 Participants
|
|
Type of radiation therapy
None
|
5 Participants
n=287 Participants
|
16 Participants
n=290 Participants
|
21 Participants
n=577 Participants
|
|
EGFR expression
High (≥ 80% of cells positive)
|
246 Participants
n=287 Participants
|
242 Participants
n=290 Participants
|
488 Participants
n=577 Participants
|
|
EGFR expression
Low (< 80% of cells positive)
|
38 Participants
n=287 Participants
|
44 Participants
n=290 Participants
|
82 Participants
n=577 Participants
|
|
EGFR expression
Not evaluable
|
3 Participants
n=287 Participants
|
4 Participants
n=290 Participants
|
7 Participants
n=577 Participants
|
|
Primary site
Oral cavity
|
183 Participants
n=287 Participants
|
184 Participants
n=290 Participants
|
367 Participants
n=577 Participants
|
|
Primary site
Larynx
|
44 Participants
n=287 Participants
|
38 Participants
n=290 Participants
|
82 Participants
n=577 Participants
|
|
Primary site
Oropharynx, p16-positive
|
50 Participants
n=287 Participants
|
55 Participants
n=290 Participants
|
105 Participants
n=577 Participants
|
|
Primary site
Oropharynx, p16-negative
|
6 Participants
n=287 Participants
|
8 Participants
n=290 Participants
|
14 Participants
n=577 Participants
|
|
Primary site
Oropharynx, p16 unknown
|
4 Participants
n=287 Participants
|
5 Participants
n=290 Participants
|
9 Participants
n=577 Participants
|
|
Lymph node > 3cm or multiple lymph nodes (centrally reviewed)
Indeterminate
|
2 Participants
n=287 Participants
|
0 Participants
n=290 Participants
|
2 Participants
n=577 Participants
|
|
Pathologic T stage
T1
|
54 Participants
n=287 Participants
|
55 Participants
n=290 Participants
|
109 Participants
n=577 Participants
|
|
Pathologic T stage
T2
|
120 Participants
n=287 Participants
|
116 Participants
n=290 Participants
|
236 Participants
n=577 Participants
|
|
Pathologic T stage
T3
|
42 Participants
n=287 Participants
|
51 Participants
n=290 Participants
|
93 Participants
n=577 Participants
|
|
Pathologic T stage
T4a
|
71 Participants
n=287 Participants
|
68 Participants
n=290 Participants
|
139 Participants
n=577 Participants
|
|
Pathologic N stage
N0
|
101 Participants
n=287 Participants
|
105 Participants
n=290 Participants
|
206 Participants
n=577 Participants
|
|
Pathologic N stage
N1
|
56 Participants
n=287 Participants
|
62 Participants
n=290 Participants
|
118 Participants
n=577 Participants
|
|
Pathologic N stage
N2a
|
15 Participants
n=287 Participants
|
13 Participants
n=290 Participants
|
28 Participants
n=577 Participants
|
|
Pathologic N stage
N2b
|
88 Participants
n=287 Participants
|
99 Participants
n=290 Participants
|
187 Participants
n=577 Participants
|
|
Pathologic N stage
N2c
|
23 Participants
n=287 Participants
|
6 Participants
n=290 Participants
|
29 Participants
n=577 Participants
|
|
Pathologic N stage
NX
|
4 Participants
n=287 Participants
|
5 Participants
n=290 Participants
|
9 Participants
n=577 Participants
|
|
Pathologic AJCC stage
Stage I (T1, N0, M0)
|
7 Participants
n=287 Participants
|
6 Participants
n=290 Participants
|
13 Participants
n=577 Participants
|
|
Lymph node > 3cm or multiple lymph nodes (centrally reviewed)
Unknown
|
6 Participants
n=287 Participants
|
14 Participants
n=290 Participants
|
20 Participants
n=577 Participants
|
|
Pathologic AJCC stage
Stage II (T2, N0, M0)
|
33 Participants
n=287 Participants
|
38 Participants
n=290 Participants
|
71 Participants
n=577 Participants
|
|
Pathologic AJCC stage
Stage III (T3, N0, M0; T1-3, N1, M0)
|
63 Participants
n=287 Participants
|
71 Participants
n=290 Participants
|
134 Participants
n=577 Participants
|
|
Pathologic AJCC stage
Stage IV (T4a, N0-2, M0; any T, N2, M0; T4b, any N, M0; any T, N3, M0; any T, Any N, M1)
|
182 Participants
n=287 Participants
|
171 Participants
n=290 Participants
|
353 Participants
n=577 Participants
|
|
Pathologic AJCC stage
Unknown
|
2 Participants
n=287 Participants
|
4 Participants
n=290 Participants
|
6 Participants
n=577 Participants
|
|
Number of intermediate risk factors (centrally reviewed)
5
|
8 Participants
n=287 Participants
|
9 Participants
n=290 Participants
|
17 Participants
n=577 Participants
|
|
Number of intermediate risk factors (centrally reviewed)
1
|
36 Participants
n=287 Participants
|
46 Participants
n=290 Participants
|
82 Participants
n=577 Participants
|
|
Number of intermediate risk factors (centrally reviewed)
2
|
121 Participants
n=287 Participants
|
105 Participants
n=290 Participants
|
226 Participants
n=577 Participants
|
|
Number of intermediate risk factors (centrally reviewed)
3
|
92 Participants
n=287 Participants
|
92 Participants
n=290 Participants
|
184 Participants
n=577 Participants
|
|
Number of intermediate risk factors (centrally reviewed)
4
|
30 Participants
n=287 Participants
|
37 Participants
n=290 Participants
|
67 Participants
n=577 Participants
|
|
Lymph node > 3cm or multiple lymph nodes (centrally reviewed)
Yes
|
119 Participants
n=287 Participants
|
121 Participants
n=290 Participants
|
240 Participants
n=577 Participants
|
|
Number of intermediate risk factors (centrally reviewed)
6
|
0 Participants
n=287 Participants
|
1 Participants
n=290 Participants
|
1 Participants
n=577 Participants
|
|
Perineural invasion (centrally reviewed)
No
|
161 Participants
n=287 Participants
|
148 Participants
n=290 Participants
|
309 Participants
n=577 Participants
|
|
Perineural invasion (centrally reviewed)
Yes
|
114 Participants
n=287 Participants
|
121 Participants
n=290 Participants
|
235 Participants
n=577 Participants
|
|
Perineural invasion (centrally reviewed)
Indeterminate
|
2 Participants
n=287 Participants
|
0 Participants
n=290 Participants
|
2 Participants
n=577 Participants
|
|
Perineural invasion (centrally reviewed)
Unknown
|
10 Participants
n=287 Participants
|
21 Participants
n=290 Participants
|
31 Participants
n=577 Participants
|
|
Lymphovascular invasion (centrally reviewed)
No
|
196 Participants
n=287 Participants
|
179 Participants
n=290 Participants
|
375 Participants
n=577 Participants
|
|
Lymphovascular invasion (centrally reviewed)
Yes
|
73 Participants
n=287 Participants
|
83 Participants
n=290 Participants
|
156 Participants
n=577 Participants
|
|
Lymphovascular invasion (centrally reviewed)
Indeterminate
|
5 Participants
n=287 Participants
|
5 Participants
n=290 Participants
|
10 Participants
n=577 Participants
|
|
Lymphovascular invasion (centrally reviewed)
Unknown
|
13 Participants
n=287 Participants
|
23 Participants
n=290 Participants
|
36 Participants
n=577 Participants
|
|
Lymph node > 3cm or multiple lymph nodes (centrally reviewed)
No
|
160 Participants
n=287 Participants
|
155 Participants
n=290 Participants
|
315 Participants
n=577 Participants
|
|
Close margins of resection (centrally reviewed)
No
|
39 Participants
n=287 Participants
|
33 Participants
n=290 Participants
|
72 Participants
n=577 Participants
|
|
Close margins of resection (centrally reviewed)
Yes
|
226 Participants
n=287 Participants
|
223 Participants
n=290 Participants
|
449 Participants
n=577 Participants
|
|
Close margins of resection (centrally reviewed)
Indeterminate
|
1 Participants
n=287 Participants
|
4 Participants
n=290 Participants
|
5 Participants
n=577 Participants
|
|
Close margins of resection (centrally reviewed)
Unknown
|
21 Participants
n=287 Participants
|
30 Participants
n=290 Participants
|
51 Participants
n=577 Participants
|
|
T3 or microscopic T4a (centrally reviewed)
No
|
175 Participants
n=287 Participants
|
179 Participants
n=290 Participants
|
354 Participants
n=577 Participants
|
|
T3 or microscopic T4a (centrally reviewed)
Yes
|
110 Participants
n=287 Participants
|
109 Participants
n=290 Participants
|
219 Participants
n=577 Participants
|
|
T3 or microscopic T4a (centrally reviewed)
Unknown
|
2 Participants
n=287 Participants
|
2 Participants
n=290 Participants
|
4 Participants
n=577 Participants
|
|
T2 oral cavity with >5mm depth of invasion (centrally reviewed)
No
|
203 Participants
n=287 Participants
|
207 Participants
n=290 Participants
|
410 Participants
n=577 Participants
|
|
T2 oral cavity with >5mm depth of invasion (centrally reviewed)
Yes
|
72 Participants
n=287 Participants
|
74 Participants
n=290 Participants
|
146 Participants
n=577 Participants
|
|
T2 oral cavity with >5mm depth of invasion (centrally reviewed)
Unknown
|
12 Participants
n=287 Participants
|
9 Participants
n=290 Participants
|
21 Participants
n=577 Participants
|
PRIMARY outcome
Timeframe: From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.Population: Randomized eligible participants
Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided.
Outcome measures
| Measure |
IMRT
n=287 Participants
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
|
IMRT Plus Cetuximab
n=290 Participants
Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
|
|---|---|---|
|
Percentage of Participants Alive (Overall Survival)
|
68.7 percentage of participants
Interval 63.1 to 74.3
|
76.5 percentage of participants
Interval 71.4 to 81.6
|
SECONDARY outcome
Timeframe: From start of radiation therapy to 90 daysPopulation: Randomized eligible participants who started protocol treatment
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events (AEs) assessed to be definitely, probably, or possibly related to protocol treatment were included. If relationship was missing, it was assumed to be definitely, probably, or possibly related to protocol treatment. Acute adverse events are those occurring within 90 days of the start of radiation therapy.
Outcome measures
| Measure |
IMRT
n=282 Participants
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
|
IMRT Plus Cetuximab
n=276 Participants
Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
|
|---|---|---|
|
Percentage of Participants With ≥ Grade 3 Acute Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment
Dysphagia
|
13.1 percentage of participants
Interval 9.7 to 17.6
|
21.7 percentage of participants
Interval 17.3 to 27.0
|
|
Percentage of Participants With ≥ Grade 3 Acute Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment
Dry mouth (xerostomia)
|
3.5 percentage of participants
Interval 1.9 to 6.4
|
1.8 percentage of participants
Interval 0.8 to 4.2
|
|
Percentage of Participants With ≥ Grade 3 Acute Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment
Dermatitis radiation
|
6.4 percentage of participants
Interval 4.1 to 9.9
|
17.0 percentage of participants
Interval 13.1 to 21.9
|
|
Percentage of Participants With ≥ Grade 3 Acute Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment
Rash acneiform
|
0.0 percentage of participants
Interval 0.0 to 1.3
|
13.4 percentage of participants
Interval 9.9 to 17.9
|
SECONDARY outcome
Timeframe: From start of radiation therapy to 90 days.Population: Randomized eligible participants who started protocol treatment
Adverse events other than dysphagia, dermatitis radiation, and rash acneiform. Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events (AEs) assessed to be definitely, probably, or possibly related to protocol treatment were included. If relationship was missing, it was assumed to be definitely, probably, or possibly related to protocol treatment. Acute adverse events are those occurring within 90 days of the start of radiation therapy.
Outcome measures
| Measure |
IMRT
n=282 Participants
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
|
IMRT Plus Cetuximab
n=276 Participants
Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
|
|---|---|---|
|
Percentage of Participants With Other ≥ Grade 3 Adverse Events Related to Protocol Treatment
|
33.0 percentage of participants
Interval 27.8 to 38.7
|
64.1 percentage of participants
Interval 58.3 to 69.6
|
SECONDARY outcome
Timeframe: From 91 days after start of radiation therapy to date of last reported follow-up. Maximum follow-up at time of analysis was 12.1 years.Population: Randomized eligible participants who started protocol treatment and had follow-up data at or after day 91 from start of radiation therapy
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events assessed to be definitely, probably, or possibly related to protocol treatment were included. If relationship was missing, it was assumed to be definitely, probably, or possibly related to protocol treatment. Late adverse events are those occurring after days from the start of radiation therapy.
Outcome measures
| Measure |
IMRT
n=279 Participants
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
|
IMRT Plus Cetuximab
n=268 Participants
Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
|
|---|---|---|
|
Percentage of Participants With ≥ Grade 3 Late Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment
Dermatitis radiation
|
1.4 percentage of participants
Interval 0.6 to 3.6
|
2.2 percentage of participants
Interval 1.0 to 4.8
|
|
Percentage of Participants With ≥ Grade 3 Late Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment
Rash acneiform
|
0.0 percentage of participants
Interval 0.0 to 1.4
|
1.5 percentage of participants
Interval 0.6 to 3.8
|
|
Percentage of Participants With ≥ Grade 3 Late Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment
Dysphagia
|
8.6 percentage of participants
Interval 5.8 to 12.5
|
12.3 percentage of participants
Interval 8.9 to 16.8
|
|
Percentage of Participants With ≥ Grade 3 Late Dysphagia, Dry Mouth, or Skin Toxicity Related to Protocol Treatment
Dry mouth (xerostomia)
|
3.2 percentage of participants
Interval 1.7 to 6.0
|
1.5 percentage of participants
Interval 0.6 to 3.8
|
SECONDARY outcome
Timeframe: From 91 days after start of radiation therapy to date of last reported follow-up. Maximum follow-up at time of analysis was 12.1 years.Population: Randomized eligible participants who started protocol treatment and had follow-up data at or after day 91 from start of radiation therapy
Adverse events other than dysphagia, dermatitis radiation, and rash acneiform. Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events (AEs) assessed to be definitely, probably, or possibly related to protocol treatment were included. If relationship was missing, it was assumed to be definitely, probably, or possibly related to protocol treatment. Late adverse events are those occurring after days from the start of radiation therapy.
Outcome measures
| Measure |
IMRT
n=279 Participants
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
|
IMRT Plus Cetuximab
n=268 Participants
Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
|
|---|---|---|
|
Percentage of Participants With Other ≥ Grade 3 Late Adverse Events Related to Protocol Treatment
|
20.8 percentage of participants
Interval 16.4 to 25.9
|
26.1 percentage of participants
Interval 21.2 to 31.7
|
SECONDARY outcome
Timeframe: From randomization to date of LRR, DM, death or last known follow-up, whichever occurred first. Maximum follow-up at time of analysis was 12.1 years.Population: Randomized eligible participants
Disease is defined as local-regional progression/recurrence (LRR) or distant metastasis (DM). LRR is defined as recurrent cancer in the tumor bed and/or neck not clearly attributable to a second primary neoplasm; both imaging and biopsy confirmation are strongly recommended. DM is defined as clear evidence of distant metastases; biopsy is recommended where possible. Disease-free survival time is defined as time from randomization to the date of first disease, death, or last known follow-up (censored), whichever occurred first. Disease-free survival rates are estimated using the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of disease-free survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided.
Outcome measures
| Measure |
IMRT
n=287 Participants
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
|
IMRT Plus Cetuximab
n=290 Participants
Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
|
|---|---|---|
|
Disease-free Survival
|
63.6 percentage of participants
Interval 57.8 to 69.3
|
71.7 percentage of participants
Interval 66.3 to 77.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to 2 years.Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to 2 years.Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to 2 years.Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to 2 years.Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to date of failure (local or regional progression or distant progression or death) or last follow-up. Analysis occurs at the same time as the primary outcome.Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.Population: Randomized eligible participants. Data were stratified by sex.
Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided.
Outcome measures
| Measure |
IMRT
n=287 Participants
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
|
IMRT Plus Cetuximab
n=290 Participants
Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
|
|---|---|---|
|
Percentage of Participants Alive (Overall Survival) by Sex
Female
|
75.3 percentage of participants
Interval 65.8 to 84.7
|
72.1 percentage of participants
Interval 62.4 to 81.8
|
|
Percentage of Participants Alive (Overall Survival) by Sex
Male
|
65.9 percentage of participants
Interval 59.0 to 72.7
|
78.5 percentage of participants
Interval 72.6 to 84.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.Population: Randomized eligible participants. Data were stratified by ethnicity.
NIH-required analysis. Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided.
Outcome measures
| Measure |
IMRT
n=287 Participants
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
|
IMRT Plus Cetuximab
n=290 Participants
Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
|
|---|---|---|
|
Percentage of Participants Alive (Overall Survival) by Ethnicity
Hispanic or Latino
|
81.8 percentage of participants
Interval 65.7 to 97.9
|
80.0 percentage of participants
Interval 59.8 to 100.0
|
|
Percentage of Participants Alive (Overall Survival) by Ethnicity
Not Hispanic or Latino
|
66.9 percentage of participants
Interval 60.9 to 72.9
|
76.2 percentage of participants
Interval 70.9 to 81.5
|
|
Percentage of Participants Alive (Overall Survival) by Ethnicity
Unknown or Not Reported
|
88.9 percentage of participants
Interval 68.4 to 100.0
|
83.3 percentage of participants
Interval 53.5 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.Population: Randomized eligible participants. Data were stratified by race.
NIH-required analysis. Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided.
Outcome measures
| Measure |
IMRT
n=287 Participants
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
|
IMRT Plus Cetuximab
n=290 Participants
Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
|
|---|---|---|
|
Percentage of Participants Alive (Overall Survival) by Race
White
|
70.1 percentage of participants
Interval 64.2 to 76.0
|
76.8 percentage of participants
Interval 71.3 to 82.3
|
|
Percentage of Participants Alive (Overall Survival) by Race
Unknown for Not Reported
|
83.3 percentage of participants
Interval 53.5 to 100.0
|
80.0 percentage of participants
Interval 44.9 to 100.0
|
|
Percentage of Participants Alive (Overall Survival) by Race
American Indian or Alaska Native
|
—
|
0 percentage of participants
Cannot be calculated because the participant was censored prior to the timepoint.
|
|
Percentage of Participants Alive (Overall Survival) by Race
Asian
|
53.6 percentage of participants
Interval 14.2 to 92.9
|
91.7 percentage of participants
Interval 76.0 to 100.0
|
|
Percentage of Participants Alive (Overall Survival) by Race
Native Hawaiian or Other Pacific Islander
|
0 percentage of participants
Cannot be calculated because the participant was censored prior to the timepoint.
|
—
|
|
Percentage of Participants Alive (Overall Survival) by Race
Black or African American
|
57.9 percentage of participants
Interval 35.7 to 80.1
|
69.6 percentage of participants
Interval 49.3 to 90.0
|
|
Percentage of Participants Alive (Overall Survival) by Race
More than one race
|
50.0 percentage of participants
Interval 0.0 to 100.0
|
—
|
Adverse Events
IMRT
Serious events: 50 serious events
Other events: 278 other events
Deaths: 97 deaths
IMRT Plus Cetuximab
Serious events: 83 serious events
Other events: 275 other events
Deaths: 87 deaths
Serious adverse events
| Measure |
IMRT
n=282 participants at risk
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
|
IMRT Plus Cetuximab
n=276 participants at risk
Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.1%
3/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.71%
2/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.71%
2/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.72%
2/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
1.8%
5/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.72%
2/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
2.5%
7/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
4.3%
12/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Esophageal fistula
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.8%
8/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
6.5%
18/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.71%
2/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
2.2%
6/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Oral pain
|
1.8%
5/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
1.4%
4/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.71%
2/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
2.9%
8/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
General disorders
Chills
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
General disorders
Edema limbs
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
General disorders
Fatigue
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
General disorders
Fever
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
1.8%
5/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
General disorders
Infusion related reaction
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
1.4%
4/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
General disorders
Malaise
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
General disorders
Pain
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.72%
2/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Infections and infestations
Infections and infestations - Other
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
1.1%
3/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Infections and infestations
Infective myositis
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Infections and infestations
Lung infection
|
0.71%
2/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
1.1%
3/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.72%
2/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Infections and infestations
Paronychia
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Infections and infestations
Salivary gland infection
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Infections and infestations
Sepsis
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.72%
2/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Infections and infestations
Skin infection
|
0.71%
2/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.72%
2/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Infections and infestations
Soft tissue infection
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Infections and infestations
Upper respiratory infection
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Infections and infestations
Wound infection
|
1.4%
4/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.71%
2/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
1.1%
3/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Investigations
Creatinine increased
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Investigations
Lymphocyte count decreased
|
1.1%
3/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
1.1%
3/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Investigations
Lymphocyte count increased
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Investigations
Platelet count decreased
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Investigations
Weight loss
|
0.71%
2/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Investigations
White blood cell decreased
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.71%
2/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.1%
6/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
4.3%
12/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
1.4%
4/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
1.1%
3/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Aphonia
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Dizziness
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.72%
2/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Myelitis
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Neuralgia
|
0.71%
2/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.72%
2/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Stroke
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Syncope
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Psychiatric disorders
Confusion
|
0.71%
2/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Psychiatric disorders
Insomnia
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.71%
2/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.72%
2/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
1.8%
5/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
1.1%
3/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.71%
2/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.72%
2/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.71%
2/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
1.8%
5/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.00%
0/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.35%
1/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.72%
2/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Vascular disorders
Hypotension
|
0.71%
2/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
1.1%
3/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
0.36%
1/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
Other adverse events
| Measure |
IMRT
n=282 participants at risk
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
|
IMRT Plus Cetuximab
n=276 participants at risk
Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
13.8%
39/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
26.8%
74/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
6.0%
17/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
8.3%
23/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Ear and labyrinth disorders
Hearing impaired
|
11.7%
33/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
14.5%
40/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
1.1%
3/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
5.8%
16/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Endocrine disorders
Hypothyroidism
|
15.2%
43/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
19.2%
53/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
6/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
7.6%
21/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Constipation
|
13.8%
39/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
29.0%
80/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
20/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
14.5%
40/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
89.7%
253/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
89.1%
246/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.6%
13/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
8.7%
24/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
86.5%
244/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
90.6%
250/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
17.7%
50/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
20.7%
57/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
79.4%
224/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
84.1%
232/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Nausea
|
29.4%
83/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
43.8%
121/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Oral pain
|
37.2%
105/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
41.3%
114/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
6.4%
18/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
7.6%
21/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Gastrointestinal disorders
Vomiting
|
16.0%
45/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
22.8%
63/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
General disorders
Chills
|
2.1%
6/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
6.5%
18/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
General disorders
Edema face
|
7.4%
21/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
8.3%
23/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
General disorders
Edema limbs
|
1.8%
5/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
5.8%
16/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
General disorders
Facial pain
|
5.7%
16/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
4.7%
13/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
General disorders
Fatigue
|
58.5%
165/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
69.6%
192/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
General disorders
Fever
|
2.1%
6/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
6.9%
19/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
General disorders
General disorders and administration site conditions - Other
|
3.5%
10/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
5.8%
16/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
General disorders
Localized edema
|
6.4%
18/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
3.3%
9/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
General disorders
Neck edema
|
11.7%
33/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
6.9%
19/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
General disorders
Pain
|
24.1%
68/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
23.9%
66/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Infections and infestations
Infections and infestations - Other
|
3.9%
11/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
8.3%
23/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Infections and infestations
Mucosal infection
|
8.5%
24/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
10.1%
28/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
79.1%
223/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
76.8%
212/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
4.6%
13/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
7.2%
20/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Investigations
Alanine aminotransferase increased
|
3.5%
10/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
12.3%
34/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Investigations
Alkaline phosphatase increased
|
4.3%
12/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
6.9%
19/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
15/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
10.1%
28/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Investigations
Lymphocyte count decreased
|
17.0%
48/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
31.5%
87/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Investigations
Platelet count decreased
|
3.5%
10/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
5.4%
15/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Investigations
Weight loss
|
37.6%
106/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
45.7%
126/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Investigations
White blood cell decreased
|
7.8%
22/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
13.8%
38/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
27.0%
76/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
33.3%
92/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.2%
23/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
10.1%
28/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.5%
7/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
5.4%
15/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.4%
21/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
15.9%
44/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.5%
7/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
6.9%
19/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.6%
13/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
18.5%
51/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.0%
14/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
11.2%
31/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.2%
9/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
11.6%
32/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.8%
8/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
12.3%
34/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.6%
13/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
18.1%
50/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.5%
10/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
5.4%
15/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
7.8%
22/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
7.6%
21/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
7.8%
22/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
12.3%
34/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
17.7%
50/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
24.6%
68/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck soft tissue necrosis
|
6.0%
17/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
5.8%
16/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
14/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
8.0%
22/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
12.1%
34/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
12.7%
35/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
20.2%
57/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
19.9%
55/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Dizziness
|
8.5%
24/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
12.3%
34/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Dysarthria
|
2.8%
8/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
6.2%
17/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Dysgeusia
|
51.1%
144/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
56.5%
156/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Headache
|
7.8%
22/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
16.3%
45/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Neuralgia
|
9.9%
28/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
7.2%
20/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Paresthesia
|
6.0%
17/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
4.7%
13/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.9%
28/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
13.0%
36/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Psychiatric disorders
Anxiety
|
10.3%
29/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
12.3%
34/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Psychiatric disorders
Depression
|
10.6%
30/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
13.0%
36/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Psychiatric disorders
Insomnia
|
8.2%
23/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
16.7%
46/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.1%
34/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
16.7%
46/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.5%
24/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
13.4%
37/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
12.8%
36/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
13.0%
36/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
16.0%
45/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
15.2%
42/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
9.6%
27/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
10.5%
29/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
18.8%
53/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
18.1%
50/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.8%
5/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
5.1%
14/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
15.6%
44/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
18.8%
52/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
7.4%
21/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
8.7%
24/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.0%
17/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
9.1%
25/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.6%
13/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
13.4%
37/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.9%
28/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
34.1%
94/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.8%
5/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
72.1%
199/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.5%
7/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
27.2%
75/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
6.0%
17/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
13.4%
37/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
10.3%
29/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
11.2%
31/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
20.9%
59/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
23.6%
65/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Vascular disorders
Hypertension
|
7.1%
20/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
11.2%
31/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
|
Vascular disorders
Lymphedema
|
14.2%
40/282 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
10.9%
30/276 • From randomization to date of death or last follow-up. Maximum follow-up at time of analysis was 12.1 years.
All-cause mortality was assessed in randomized eligible participants. Adverse events were assessed in randomized eligible participants who started protocol treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER