Trial Outcomes & Findings for TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer. (NCT NCT01711658)
NCT ID: NCT01711658
Last Updated: 2023-10-17
Results Overview
An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of survival times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided. Analysis occurred after 67 progressions or deaths were reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
142 participants
Primary outcome timeframe
From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years.
Results posted on
2023-10-17
Participant Flow
After first step registration and prior to randomization, patients with oropharyngeal cancer were tested for p16. Only patients with p16-negative tumors continued to randomization. Patients with larynx or hypopharynx cancer did not require p16 testing. In total, 142 patients were enrolled and 127 were randomized.
Participant milestones
| Measure |
IMRT + Cisplatin + Placebo
Intensity Modulated Radiation Therapy (IMRT), 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Placebo: 1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
IMRT + Cisplatin + Lapatinib
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Lapatinib: 1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
63
|
|
Overall Study
Participants Who Started Protocol Treatment
|
59
|
60
|
|
Overall Study
COMPLETED
|
64
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two patients are missing smoking history data.
Baseline characteristics by cohort
| Measure |
IMRT + Cisplatin + Placebo
n=64 Participants
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Placebo: 1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
IMRT + Cisplatin + Lapatinib
n=63 Participants
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Lapatinib: 1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=64 Participants
|
57 years
n=63 Participants
|
58 years
n=127 Participants
|
|
Age, Customized
<=65
|
54 Participants
n=64 Participants
|
56 Participants
n=63 Participants
|
110 Participants
n=127 Participants
|
|
Age, Customized
>65
|
10 Participants
n=64 Participants
|
7 Participants
n=63 Participants
|
17 Participants
n=127 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=64 Participants
|
16 Participants
n=63 Participants
|
29 Participants
n=127 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=64 Participants
|
47 Participants
n=63 Participants
|
98 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=64 Participants
|
1 Participants
n=63 Participants
|
4 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=64 Participants
|
61 Participants
n=63 Participants
|
121 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=64 Participants
|
1 Participants
n=63 Participants
|
2 Participants
n=127 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=64 Participants
|
1 Participants
n=63 Participants
|
2 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=64 Participants
|
0 Participants
n=63 Participants
|
2 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=64 Participants
|
0 Participants
n=63 Participants
|
2 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=64 Participants
|
10 Participants
n=63 Participants
|
19 Participants
n=127 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=64 Participants
|
50 Participants
n=63 Participants
|
99 Participants
n=127 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=64 Participants
|
1 Participants
n=63 Participants
|
1 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=64 Participants
|
1 Participants
n=63 Participants
|
2 Participants
n=127 Participants
|
|
Zubrod performance status
0
|
33 Participants
n=64 Participants
|
27 Participants
n=63 Participants
|
60 Participants
n=127 Participants
|
|
Zubrod performance status
1
|
31 Participants
n=64 Participants
|
36 Participants
n=63 Participants
|
67 Participants
n=127 Participants
|
|
Smoking history: pack-years
|
38 pack-years
n=63 Participants • Two patients are missing smoking history data.
|
29.5 pack-years
n=62 Participants • Two patients are missing smoking history data.
|
30 pack-years
n=125 Participants • Two patients are missing smoking history data.
|
|
Smoking history: pack-years
<=10
|
13 Participants
n=63 Participants • Two patients are missing smoking history data.
|
17 Participants
n=62 Participants • Two patients are missing smoking history data.
|
30 Participants
n=125 Participants • Two patients are missing smoking history data.
|
|
Smoking history: pack-years
>10
|
50 Participants
n=63 Participants • Two patients are missing smoking history data.
|
45 Participants
n=62 Participants • Two patients are missing smoking history data.
|
95 Participants
n=125 Participants • Two patients are missing smoking history data.
|
|
Primary site
Oropharynx, p16-negative (central review)
|
15 Participants
n=64 Participants
|
16 Participants
n=63 Participants
|
31 Participants
n=127 Participants
|
|
Primary site
Oropharynx, unknown p16 (central review)
|
0 Participants
n=64 Participants
|
1 Participants
n=63 Participants
|
1 Participants
n=127 Participants
|
|
Primary site
Hypopharynx
|
16 Participants
n=64 Participants
|
7 Participants
n=63 Participants
|
23 Participants
n=127 Participants
|
|
Primary site
Larynx
|
33 Participants
n=64 Participants
|
39 Participants
n=63 Participants
|
72 Participants
n=127 Participants
|
|
T stage (stratification factor)
T1
|
2 Participants
n=64 Participants
|
0 Participants
n=63 Participants
|
2 Participants
n=127 Participants
|
|
T stage (stratification factor)
T2
|
9 Participants
n=64 Participants
|
7 Participants
n=63 Participants
|
16 Participants
n=127 Participants
|
|
T stage (stratification factor)
T3
|
35 Participants
n=64 Participants
|
38 Participants
n=63 Participants
|
73 Participants
n=127 Participants
|
|
T stage (stratification factor)
T4
|
18 Participants
n=64 Participants
|
18 Participants
n=63 Participants
|
36 Participants
n=127 Participants
|
|
N stage (stratification factor)
N0
|
18 Participants
n=64 Participants
|
20 Participants
n=63 Participants
|
38 Participants
n=127 Participants
|
|
N stage (stratification factor)
N1
|
7 Participants
n=64 Participants
|
8 Participants
n=63 Participants
|
15 Participants
n=127 Participants
|
|
N stage (stratification factor)
N2a
|
3 Participants
n=64 Participants
|
2 Participants
n=63 Participants
|
5 Participants
n=127 Participants
|
|
N stage (stratification factor)
N2b
|
19 Participants
n=64 Participants
|
19 Participants
n=63 Participants
|
38 Participants
n=127 Participants
|
|
N stage (stratification factor)
N2c
|
15 Participants
n=64 Participants
|
13 Participants
n=63 Participants
|
28 Participants
n=127 Participants
|
|
N stage (stratification factor)
N3
|
2 Participants
n=64 Participants
|
1 Participants
n=63 Participants
|
3 Participants
n=127 Participants
|
|
Overall stage
II
|
1 Participants
n=64 Participants
|
0 Participants
n=63 Participants
|
1 Participants
n=127 Participants
|
|
Overall stage
III
|
18 Participants
n=64 Participants
|
20 Participants
n=63 Participants
|
38 Participants
n=127 Participants
|
|
Overall stage
IV
|
45 Participants
n=64 Participants
|
43 Participants
n=63 Participants
|
88 Participants
n=127 Participants
|
PRIMARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years.Population: All randomized participants
An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of survival times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided. Analysis occurred after 67 progressions or deaths were reported.
Outcome measures
| Measure |
IMRT + Cisplatin + Placebo
n=64 Participants
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Placebo: 1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
IMRT + Cisplatin + Lapatinib
n=63 Participants
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Lapatinib: 1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
|---|---|---|
|
Percentage of Participants Alive Without Progression (Progression-free Survival)
|
34.6 percentage of participants
Interval 21.2 to 48.0
|
43.1 percentage of participants
Interval 30.1 to 56.1
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years.Population: All randomized participants
An event for overall survival is death due to any cause. Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of survival times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided.
Outcome measures
| Measure |
IMRT + Cisplatin + Placebo
n=64 Participants
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Placebo: 1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
IMRT + Cisplatin + Lapatinib
n=63 Participants
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Lapatinib: 1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
|---|---|---|
|
Percentage of Participants Alive (Overall Survival)
|
55.1 percentage of participants
Interval 40.6 to 69.5
|
49.9 percentage of participants
Interval 35.5 to 64.3
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years.Population: All randomized participants
Failure for distant metastasis endpoint was defined as distant progression; local-regional failure and death due to any cause were considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided.
Outcome measures
| Measure |
IMRT + Cisplatin + Placebo
n=64 Participants
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Placebo: 1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
IMRT + Cisplatin + Lapatinib
n=63 Participants
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Lapatinib: 1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
|---|---|---|
|
Percentage of Participants With Distant Metastases
|
19.9 percentage of participants
Interval 10.1 to 32.2
|
12.4 percentage of participants
Interval 5.4 to 22.5
|
SECONDARY outcome
Timeframe: From start of treatment to last follow-up. Maximum follow-up at time of analysis was 7.1 years.Population: Participants Who Started Protocol Treatment
Adverse events (AE) were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event. "Treatment-related" is defined definitely, probably, or possibly related to treatment.
Outcome measures
| Measure |
IMRT + Cisplatin + Placebo
n=59 Participants
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Placebo: 1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
IMRT + Cisplatin + Lapatinib
n=60 Participants
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Lapatinib: 1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
|---|---|---|
|
Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events
|
84.7 percentage of participants
Interval 73.0 to 92.8
|
86.7 percentage of participants
Interval 75.4 to 94.1
|
SECONDARY outcome
Timeframe: From start of treatment to end of treatment (approximately 5 months from randomization).Population: All randomized participants
Compliance with protocol treatment is defined as "per protocol" or "acceptable variation" per study chair review for IMRT, cisplatin, pre-IMRT lapatinib/placebo, concurrent lapatinib/placebo, and maintenance lapatinib/placebo. Rates of treatment compliance were compared between groups by a 2-sided Fisher's exact test.
Outcome measures
| Measure |
IMRT + Cisplatin + Placebo
n=64 Participants
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Placebo: 1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
IMRT + Cisplatin + Lapatinib
n=63 Participants
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Lapatinib: 1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
|---|---|---|
|
Percentage of Participants Who Complied With Protocol Treatment
IMRT
|
76.6 percentage of participants
Interval 66.2 to 86.9
|
84.1 percentage of participants
Interval 75.1 to 93.2
|
|
Percentage of Participants Who Complied With Protocol Treatment
Cisplatin
|
90.6 percentage of participants
Interval 83.5 to 97.8
|
88.9 percentage of participants
Interval 81.1 to 96.6
|
|
Percentage of Participants Who Complied With Protocol Treatment
Pre-IMRT lapatinib/placebo
|
84.4 percentage of participants
Interval 75.5 to 93.3
|
87.3 percentage of participants
Interval 79.1 to 95.5
|
|
Percentage of Participants Who Complied With Protocol Treatment
Concurrent lapatinib/placebo
|
79.7 percentage of participants
Interval 69.8 to 89.5
|
84.1 percentage of participants
Interval 75.1 to 93.2
|
|
Percentage of Participants Who Complied With Protocol Treatment
Maintenance lapatinib/placebo
|
56.3 percentage of participants
Interval 44.1 to 68.4
|
49.2 percentage of participants
Interval 36.9 to 61.6
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 7.1 years.Population: All randomized participants
Failure for local-regional control endpoint was defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown \> 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression; distant metastasis and death due to other causes were considered competing risks. Local-regional failure time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Failure rates are estimated by the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided.
Outcome measures
| Measure |
IMRT + Cisplatin + Placebo
n=64 Participants
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Placebo: 1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
IMRT + Cisplatin + Lapatinib
n=63 Participants
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Lapatinib: 1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
|---|---|---|
|
Percentage of Participants With Local-regional Progression
|
33.7 percentage of participants
Interval 21.2 to 46.7
|
37.7 percentage of participants
Interval 25.0 to 50.4
|
SECONDARY outcome
Timeframe: 3 months, 1 year, and 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months, 1 year, and 2 years.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months, 1 year, and 2 years.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of StudyPopulation: No assays were performed, and no data were collected for this outcome measure. Specimen use will require funding separate from this trial.
Outcome measures
Outcome data not reported
Adverse Events
IMRT + Cisplatin + Placebo
Serious events: 26 serious events
Other events: 59 other events
Deaths: 23 deaths
IMRT + Cisplatin + Lapatinib
Serious events: 31 serious events
Other events: 60 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
IMRT + Cisplatin + Placebo
n=59 participants at risk
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Placebo: 1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
IMRT + Cisplatin + Lapatinib
n=60 participants at risk
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Lapatinib: 1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
3.3%
2/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Cardiac disorders
Cardiac arrest
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Cardiac disorders
Sinus tachycardia
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
3.3%
2/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Colitis
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
5.0%
3/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Dysphagia
|
10.2%
6/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Esophagitis
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Ileus
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Nausea
|
8.5%
5/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
11.7%
7/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Oral pain
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Vomiting
|
8.5%
5/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
10.0%
6/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
General disorders
Death NOS
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
General disorders
Edema limbs
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
General disorders
Fatigue
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
General disorders
Fever
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
3.3%
2/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
General disorders
Pain
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
General disorders
Sudden death NOS
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Infections and infestations
Bronchial infection
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Infections and infestations
Infections and infestations - Other
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Infections and infestations
Lung infection
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Infections and infestations
Sepsis
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Injury, poisoning and procedural complications
Injury to carotid artery
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Injury, poisoning and procedural complications
Tracheal hemorrhage
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Investigations
Creatinine increased
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
3.3%
2/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
3.3%
2/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Investigations
Weight loss
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Investigations
White blood cell decreased
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
8.3%
5/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
13.6%
8/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
11.7%
7/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
5.0%
3/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Nervous system disorders
Cognitive disturbance
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Nervous system disorders
Dizziness
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Nervous system disorders
Stroke
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Psychiatric disorders
Depression
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
8.5%
5/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
13.3%
8/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
3.3%
2/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.1%
3/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
6.8%
4/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
5.0%
3/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal mucositis
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Vascular disorders
Hypertension
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Vascular disorders
Hypotension
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
Other adverse events
| Measure |
IMRT + Cisplatin + Placebo
n=59 participants at risk
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Placebo: 1500 mg placebo daily by mouth or by feeding tube starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
IMRT + Cisplatin + Lapatinib
n=60 participants at risk
IMRT: IMRT, 35 fractions over 6 weeks, 6 fractions per week for 5 weeks and 5 fractions per week for 1 week, 2 Gy per fraction to total dose of 70 Gy
Cisplatin: 100 mg/m\^2 administered intravenously on days 8 and 29
Lapatinib: 1500 mg lapatinib by mouth or by feeding tube daily starting 7 days before IMRT for 7 weeks prior to and during IMRT and 3 months after completion of IMRT
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
64.4%
38/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
60.0%
36/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
11.9%
7/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
8.3%
5/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Cardiac disorders
Sinus tachycardia
|
6.8%
4/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Ear and labyrinth disorders
Ear pain
|
23.7%
14/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
20.0%
12/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Ear and labyrinth disorders
Hearing impaired
|
30.5%
18/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
25.0%
15/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
39.0%
23/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
23.3%
14/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Endocrine disorders
Hyperthyroidism
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
5.0%
3/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Endocrine disorders
Hypothyroidism
|
28.8%
17/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
26.7%
16/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
6.8%
4/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Constipation
|
54.2%
32/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
28.3%
17/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Dental caries
|
5.1%
3/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Diarrhea
|
13.6%
8/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
40.0%
24/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Dry mouth
|
79.7%
47/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
76.7%
46/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
13.6%
8/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
13.3%
8/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Dysphagia
|
89.8%
53/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
91.7%
55/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Esophageal pain
|
6.8%
4/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
3.3%
2/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Esophageal stenosis
|
5.1%
3/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
5.0%
3/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Esophagitis
|
5.1%
3/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
5.0%
3/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
13.6%
8/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
8.3%
5/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
20.3%
12/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
30.0%
18/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
76.3%
45/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
80.0%
48/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Nausea
|
54.2%
32/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
58.3%
35/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Oral pain
|
16.9%
10/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
21.7%
13/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
8.5%
5/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
10.0%
6/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Gastrointestinal disorders
Vomiting
|
33.9%
20/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
41.7%
25/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
General disorders
Chills
|
6.8%
4/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
General disorders
Edema face
|
10.2%
6/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
10.0%
6/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
General disorders
Edema limbs
|
5.1%
3/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
8.3%
5/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
General disorders
Fatigue
|
83.1%
49/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
81.7%
49/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
General disorders
Fever
|
13.6%
8/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
General disorders
General disorders and administration site conditions - Other
|
11.9%
7/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
8.3%
5/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
General disorders
Localized edema
|
6.8%
4/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
13.3%
8/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
General disorders
Neck edema
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
11.7%
7/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
General disorders
Non-cardiac chest pain
|
6.8%
4/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
10.0%
6/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
General disorders
Pain
|
37.3%
22/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
23.3%
14/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Infections and infestations
Infections and infestations - Other
|
8.5%
5/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Infections and infestations
Laryngitis
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
5.0%
3/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Infections and infestations
Lung infection
|
5.1%
3/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Infections and infestations
Mucosal infection
|
15.3%
9/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
8.3%
5/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Infections and infestations
Skin infection
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
5.0%
3/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Infections and infestations
Urinary tract infection
|
5.1%
3/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
3.3%
2/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
66.1%
39/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
58.3%
35/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Injury, poisoning and procedural complications
Fall
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Investigations
Alanine aminotransferase increased
|
20.3%
12/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
23.3%
14/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Investigations
Alkaline phosphatase increased
|
15.3%
9/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Investigations
Aspartate aminotransferase increased
|
10.2%
6/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
11.7%
7/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Investigations
Blood bilirubin increased
|
6.8%
4/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
16.7%
10/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Investigations
CD4 lymphocytes decreased
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
5.0%
3/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Investigations
Creatinine increased
|
30.5%
18/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
31.7%
19/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Investigations
Investigations - Other
|
8.5%
5/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Investigations
Lymphocyte count decreased
|
37.3%
22/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
43.3%
26/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Investigations
Neutrophil count decreased
|
37.3%
22/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
21.7%
13/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Investigations
Platelet count decreased
|
27.1%
16/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
23.3%
14/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Investigations
Weight loss
|
52.5%
31/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
68.3%
41/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Investigations
White blood cell decreased
|
42.4%
25/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
40.0%
24/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
54.2%
32/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
56.7%
34/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
25.4%
15/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
23.3%
14/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.8%
4/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
8.3%
5/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
27.1%
16/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
30.0%
18/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.5%
5/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
8.5%
5/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.1%
3/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
3.3%
2/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
5.1%
3/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
30.5%
18/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
33.3%
20/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.4%
15/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
26.7%
16/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.8%
17/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
38.3%
23/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
27.1%
16/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
38.3%
23/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
44.1%
26/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
48.3%
29/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.5%
5/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
11.9%
7/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
18.3%
11/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
3/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
5.0%
3/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.9%
7/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
8.3%
5/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
5.0%
3/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
6.8%
4/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
5.0%
3/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.5%
5/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
10.0%
6/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
13.6%
8/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
18.3%
11/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.3%
12/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
28.3%
17/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Neck soft tissue necrosis
|
8.5%
5/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
3.3%
2/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
15.3%
9/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
10.0%
6/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
8.5%
5/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Nervous system disorders
Dizziness
|
8.5%
5/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
13.3%
8/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Nervous system disorders
Dysgeusia
|
61.0%
36/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
63.3%
38/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Nervous system disorders
Headache
|
22.0%
13/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
20.0%
12/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Nervous system disorders
Nervous system disorders - Other
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
8.3%
5/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
5.0%
3/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
18.6%
11/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
18.3%
11/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Nervous system disorders
Tremor
|
6.8%
4/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Psychiatric disorders
Anxiety
|
27.1%
16/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
23.3%
14/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Psychiatric disorders
Confusion
|
6.8%
4/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Psychiatric disorders
Depression
|
16.9%
10/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
18.3%
11/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Psychiatric disorders
Insomnia
|
22.0%
13/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
33.3%
20/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
8.5%
5/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
5.0%
3/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
8.5%
5/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
10.0%
6/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Renal and urinary disorders
Hematuria
|
5.1%
3/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Renal and urinary disorders
Proteinuria
|
6.8%
4/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Renal and urinary disorders
Urinary retention
|
5.1%
3/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
13.6%
8/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.3%
22/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
33.3%
20/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
35.6%
21/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
26.7%
16/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
49.2%
29/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
48.3%
29/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
20.3%
12/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
20.0%
12/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
5.1%
3/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
3.3%
2/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal fistula
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
5.0%
3/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
23.7%
14/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
18.3%
11/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.5%
5/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.1%
3/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
13.6%
8/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
8.3%
5/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
16.9%
10/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
16.7%
10/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
35.6%
21/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
41.7%
25/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
20.3%
12/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
16.7%
10/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.7%
1/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
11.7%
7/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.1%
3/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
1.7%
1/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.8%
4/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
11.7%
7/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.4%
2/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
8.3%
5/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
11.9%
7/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
15.0%
9/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
8.5%
5/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
11.7%
7/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
5.1%
3/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Vascular disorders
Hot flashes
|
5.1%
3/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
0.00%
0/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Vascular disorders
Hypertension
|
13.6%
8/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
18.3%
11/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Vascular disorders
Hypotension
|
18.6%
11/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
6.7%
4/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
|
Vascular disorders
Lymphedema
|
10.2%
6/59 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in participants who started protocol treatment
|
10.0%
6/60 • Weekly during radiation therapy, then every 3 months for years 1 and 2, every 6 months for years 3-5, then annually
All-cause mortality was assessed in all randomized participants. Adverse events were assessed in 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