Trial Outcomes & Findings for Intensity-Modulated Radiation Therapy and Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Anaplastic Thyroid Cancer (NCT NCT01236547)
NCT ID: NCT01236547
Last Updated: 2022-07-19
Results Overview
Overall survival time is defined as time from randomization to the date of death (failure) from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after all eligible participants were potentially followed for 3 years.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
From randomization to last follow-up.Maximum follow-up for phase II participants at time of analysis was 4.2 years.
Results posted on
2022-07-19
Participant Flow
Participant milestones
| Measure |
(Run-in 1) Pazopanib, Paclitaxel, IMRT
Pre-Intensity-modulated radiation therapy (IMRT) pazopanib 800 mg oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 400 mg oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
Post-concurrent pazopanib 800 mg oral daily and paclitaxel 60 mg/m\^2 IV weekly, starting 4 weeks after IMRT for 12 weeks if no evidence of disease or until progression or significant toxicity if evidence of disease.
|
(Run-in 2) Pazopanib, Paclitaxil, IMRT
Pre-IMRT pazopanib 600 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Run-in 3) Pazopanib, Paclitaxel, IMRT
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Pazopanib, Paclitaxel, IMRT
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Placebo, Paclitaxel, IMRT
Pre-IMRT placebo 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent placebo 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
12
|
42
|
47
|
|
Overall Study
Eligible
|
11
|
10
|
11
|
36
|
35
|
|
Overall Study
Eligible and Started Study Treatment
|
11
|
10
|
11
|
36
|
34
|
|
Overall Study
Eligible and Response Assessed
|
0
|
0
|
0
|
23
|
27
|
|
Overall Study
COMPLETED
|
11
|
10
|
11
|
36
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
6
|
12
|
Reasons for withdrawal
| Measure |
(Run-in 1) Pazopanib, Paclitaxel, IMRT
Pre-Intensity-modulated radiation therapy (IMRT) pazopanib 800 mg oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 400 mg oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
Post-concurrent pazopanib 800 mg oral daily and paclitaxel 60 mg/m\^2 IV weekly, starting 4 weeks after IMRT for 12 weeks if no evidence of disease or until progression or significant toxicity if evidence of disease.
|
(Run-in 2) Pazopanib, Paclitaxil, IMRT
Pre-IMRT pazopanib 600 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Run-in 3) Pazopanib, Paclitaxel, IMRT
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Pazopanib, Paclitaxel, IMRT
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Placebo, Paclitaxel, IMRT
Pre-IMRT placebo 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent placebo 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
6
|
12
|
Baseline Characteristics
Intensity-Modulated Radiation Therapy and Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Anaplastic Thyroid Cancer
Baseline characteristics by cohort
| Measure |
(Run-in 1) Pazopanib, Paclitaxel, IMRT
n=11 Participants
Pre-IMRT pazopanib 800 mg oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 400 mg oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
Post-concurrent pazopanib 800 mg oral daily and paclitaxel 60 mg/m\^2 IV weekly, starting 4 weeks after IMRT for 12 weeks if no evidence of disease or until progression or significant toxicity if evidence of disease.
Intensity-Modulated Radiation Therapy: 33 fractions over 6.5 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 66 Gy
|
(Run-in 2) Pazopanib, Paclitaxil, IMRT
n=10 Participants
Pre-IMRT pazopanib 600 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Run-in 3) Pazopanib, Paclitaxel, IMRT
n=11 Participants
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Pazopanib, Paclitaxel, IMRT
n=36 Participants
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Placebo, Paclitaxel, IMRT
n=35 Participants
Pre-IMRT placebo 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent placebo 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
≤ 49
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
|
Age, Customized
50-59
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
17 Participants
n=30 Participants
|
|
Age, Customized
60-69
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
49 Participants
n=30 Participants
|
|
Age, Customized
≥ 70
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
28 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
52 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
51 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
81 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
77 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
14 Participants
n=30 Participants
|
|
Zubrod Performance Status
0
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
52 Participants
n=30 Participants
|
|
Zubrod Performance Status
1
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
44 Participants
n=30 Participants
|
|
Zubrod Performance Status
2
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
|
Prior surgery for study cancer
None
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
40 Participants
n=30 Participants
|
|
Prior surgery for study cancer
Total thyroidectomy
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
43 Participants
n=30 Participants
|
|
Prior surgery for study cancer
Partial thyroidectomy
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
20 Participants
n=30 Participants
|
|
T stage
T4a
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
30 Participants
n=30 Participants
|
|
T stage
T4b
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
73 Participants
n=30 Participants
|
|
N stage
N0
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
20 Participants
n=30 Participants
|
|
N stage
N1a
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
21 Participants
n=30 Participants
|
|
N stage
N1b
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
57 Participants
n=30 Participants
|
|
N stage
NX
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
|
M stage
M0
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
55 Participants
n=30 Participants
|
|
M stage
M1
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
39 Participants
n=30 Participants
|
|
M stage
Mx
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: From randomization to last follow-up.Maximum follow-up for phase II participants at time of analysis was 4.2 years.Population: Eligible participants on phase II arms
Overall survival time is defined as time from randomization to the date of death (failure) from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after all eligible participants were potentially followed for 3 years.
Outcome measures
| Measure |
(Phase II) Pazopanib, Paclitaxel, IMRT
n=36 Participants
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Placebo, Paclitaxel, IMRT
n=35 Participants
Pre-IMRT placebo 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent placebo 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Run-in 3) Pazopanib, Paclitaxel, IMRT
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Pazopanib, Paclitaxel, IMRT
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
Intensity-Modulated Radiation Therapy: 33 fractions over 6.5 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 66 Gy
|
|---|---|---|---|---|
|
(Phase II) Overall Survival
|
37.1 percentage of participants
Interval 21.1 to 53.2
|
29.0 percentage of participants
Interval 13.2 to 44.8
|
—
|
—
|
PRIMARY outcome
Timeframe: From registration to last follow-up. Maximum follow-up for run-in and phase II participants at time of analysis was 7.4 years.Population: First nine eligible participants in run-in each arm and first 15 eligible participants in phase II pazopanib arm.
Common Terminology Criteria for AEs (version 4.0) grades AE severity from 1=mild to 5=death. Discontinuation of treatment due to toxicity is defined as \< 75% of planned radiation therapy delivered. "Treatment-related" = definitely, probably, or possibly related to treatment. A single run-in arm was originally planned, but additional run-in arms were added due to amendments to the protocol regimen unrelated to toxicities. A two-stage design based on the binomial distribution was used in which the 1st stage analyzes the run-in arm and the 2nd stage analyzes run-in and phase II pazopanib arm participants combined. Because there were multiple run-in arms, only the last is used in the 2nd stage analysis. 1st stage: If ≤4 of 9 participants experience AEC, then conclude treatment is safe. 2nd stage: If ≤8 of 24 participants experience AEC, then conclude treatment safe. Otherwise conclude the treatment is too toxic. Summary data is provided here, see AE Module for specific AE data.
Outcome measures
| Measure |
(Phase II) Pazopanib, Paclitaxel, IMRT
n=9 Participants
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Placebo, Paclitaxel, IMRT
n=9 Participants
Pre-IMRT placebo 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent placebo 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Run-in 3) Pazopanib, Paclitaxel, IMRT
n=9 Participants
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Pazopanib, Paclitaxel, IMRT
n=15 Participants
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
Intensity-Modulated Radiation Therapy: 33 fractions over 6.5 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 66 Gy
|
|---|---|---|---|---|
|
(Phase I) Number of Participants With Treatment-related Grade 4 Hemorrhage, Grade 4 Febrile Neutropenia, or Grade 5 Adverse Event (AE), or Discontinuation of Treatment Due to Toxicity [Adverse Events of Concern (AEC)]
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From randomization to last follow-up.Maximum follow-up for phase II participants at time of analysis was 4.2 years. (Statistical analysis compares full distributions therefore all available follow-up was used.)Population: Eligible participants on phase II arms
Local-regional failure is defined as local-regional relapse/progression in the thyroid bed or regional lymph nodes. Time to local-regional failure is defined as time from randomization to the date of first local-regional recurrence, last known follow-up (censored), or death without local recurrence (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies 6- and 12-month estimates to be reported and for the full distributions of failure times to be compared between the arms. Analysis occurred after all eligible participants were potentially followed for 3 years.
Outcome measures
| Measure |
(Phase II) Pazopanib, Paclitaxel, IMRT
n=36 Participants
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Placebo, Paclitaxel, IMRT
n=35 Participants
Pre-IMRT placebo 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent placebo 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Run-in 3) Pazopanib, Paclitaxel, IMRT
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Pazopanib, Paclitaxel, IMRT
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
Intensity-Modulated Radiation Therapy: 33 fractions over 6.5 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 66 Gy
|
|---|---|---|---|---|
|
(Phase II) Local-regional Control
6 months
|
20.0 percentage of participants
Interval 8.6 to 34.8
|
27.3 percentage of participants
Interval 13.3 to 43.3
|
—
|
—
|
|
(Phase II) Local-regional Control
1 year
|
28.6 percentage of participants
Interval 14.6 to 44.3
|
33.6 percentage of participants
Interval 17.9 to 50.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment to last follow-up.Maximum follow-up for phase II participants at time of analysis was 4.2 years.Population: Eligible phase II participants who started study treatment
Common Terminology Criteria for Adverse Events (CTCAE, v. 4.0) grades adverse event severity from 1=mild to 5=death. Discontinuation of treatment due to toxicity is defined as \< 75% of planned radiation therapy delivered. Adverse events rated as definitely, probably, or possibly related to treatment were considered treatment-related. Summary data is provided in this outcome measure.; See Adverse Events Module for specific adverse event data.
Outcome measures
| Measure |
(Phase II) Pazopanib, Paclitaxel, IMRT
n=36 Participants
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Placebo, Paclitaxel, IMRT
n=34 Participants
Pre-IMRT placebo 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent placebo 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Run-in 3) Pazopanib, Paclitaxel, IMRT
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Pazopanib, Paclitaxel, IMRT
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
Intensity-Modulated Radiation Therapy: 33 fractions over 6.5 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 66 Gy
|
|---|---|---|---|---|
|
(Phase II) Percentage of Participants With Treatment-related Grade 4 Hemorrhage, Grade 4 Febrile Neutropenia, or Grade 5 Adverse Event, or Discontinuation of Treatment Due to Toxicity [Adverse Events of Concern]
|
2.8 percentage of participants
Interval 0.1 to 14.5
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment to last follow-up.Maximum follow-up for phase II participants at time of analysis was 4.2 years.Population: Eligible phase II participants who started study treatment
Common Terminology Criteria for Adverse Events (CTCAE, v. 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events rated as definitely, probably, or possibly related to treatment were considered treatment-related. Summary data is provided in this outcome measure.; See Adverse Events Module for specific adverse event data.
Outcome measures
| Measure |
(Phase II) Pazopanib, Paclitaxel, IMRT
n=36 Participants
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Placebo, Paclitaxel, IMRT
n=34 Participants
Pre-IMRT placebo 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent placebo 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Run-in 3) Pazopanib, Paclitaxel, IMRT
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Pazopanib, Paclitaxel, IMRT
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
Intensity-Modulated Radiation Therapy: 33 fractions over 6.5 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 66 Gy
|
|---|---|---|---|---|
|
(Phase II) Percentage of Participants With Treatment-related Grade 3 or 4 Adverse Events Other Than Grade 4 Hemorrhage or Grade 4 Febrile Neutropenia [Not Adverse Events of Concern]
|
86.1 percentage of participants
Interval 70.5 to 95.3
|
85.3 percentage of participants
Interval 68.9 to 95.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 2-4 weeks after treatment (approximately week 10-14)Population: Eligible participants on phase II arms that with response evaluated
Complete Response: Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
(Phase II) Pazopanib, Paclitaxel, IMRT
n=23 Participants
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Placebo, Paclitaxel, IMRT
n=27 Participants
Pre-IMRT placebo 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent placebo 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Run-in 3) Pazopanib, Paclitaxel, IMRT
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Pazopanib, Paclitaxel, IMRT
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
Intensity-Modulated Radiation Therapy: 33 fractions over 6.5 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 66 Gy
|
|---|---|---|---|---|
|
(Phase II) Percentage of Participants With Complete or Partial Response of the Primary Site After Chemoradiation Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
|
30.4 percentage of participants
Interval 13.2 to 52.9
|
33.3 percentage of participants
Interval 16.5 to 54.0
|
—
|
—
|
Adverse Events
(Run-in 1) Pazopanib, Paclitaxel, IMRT
Serious events: 9 serious events
Other events: 10 other events
Deaths: 9 deaths
(Run-in 2) Pazopanib, Paclitaxil, IMRT
Serious events: 6 serious events
Other events: 10 other events
Deaths: 10 deaths
(Run-in 3) Pazopanib, Paclitaxel, IMRT
Serious events: 8 serious events
Other events: 11 other events
Deaths: 11 deaths
(Phase II) Pazopanib, Paclitaxel, IMRT
Serious events: 28 serious events
Other events: 36 other events
Deaths: 31 deaths
(Phase II) Placebo, Paclitaxel, IMRT
Serious events: 22 serious events
Other events: 33 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
(Run-in 1) Pazopanib, Paclitaxel, IMRT
n=11 participants at risk
Pre-IMRT pazopanib 800 mg oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 400 mg oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
Post-concurrent pazopanib 800 mg oral daily and paclitaxel 60 mg/m\^2 IV weekly, starting 4 weeks after IMRT for 12 weeks if no evidence of disease or until progression or significant toxicity if evidence of disease.
|
(Run-in 2) Pazopanib, Paclitaxil, IMRT
n=10 participants at risk
Pre-IMRT pazopanib 600 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Run-in 3) Pazopanib, Paclitaxel, IMRT
n=11 participants at risk
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Pazopanib, Paclitaxel, IMRT
n=36 participants at risk
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Placebo, Paclitaxel, IMRT
n=34 participants at risk
Pre-IMRT placebo 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent placebo 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Cardiac disorders
Cardiac disorders - Other
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Dysphagia
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
40.0%
4/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
16.7%
6/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Esophageal fistula
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.8%
4/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.8%
3/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
General disorders
Death NOS
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
General disorders
Fever
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
General disorders
Neck edema
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
General disorders
Pain
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Infections and infestations
Catheter related infection
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Infections and infestations
Lung infection
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Infections and infestations
Sepsis
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.3%
3/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Infections and infestations
Skin infection
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Injury, poisoning and procedural complications
Tracheal hemorrhage
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Injury, poisoning and procedural complications
Tracheostomy site bleeding
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Alanine aminotransferase increased
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Alkaline phosphatase increased
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Blood bilirubin increased
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Investigations - Other
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Lymphocyte count decreased
|
45.5%
5/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
20.0%
2/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.3%
3/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Weight loss
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
White blood cell decreased
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.1%
4/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.1%
4/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.8%
3/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Nervous system disorders
Recurrent laryngeal nerve palsy
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Nervous system disorders
Syncope
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.3%
3/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.3%
3/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.8%
3/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Vascular disorders
Hematoma
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Vascular disorders
Hypotension
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.1%
4/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
Other adverse events
| Measure |
(Run-in 1) Pazopanib, Paclitaxel, IMRT
n=11 participants at risk
Pre-IMRT pazopanib 800 mg oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 400 mg oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
Post-concurrent pazopanib 800 mg oral daily and paclitaxel 60 mg/m\^2 IV weekly, starting 4 weeks after IMRT for 12 weeks if no evidence of disease or until progression or significant toxicity if evidence of disease.
|
(Run-in 2) Pazopanib, Paclitaxil, IMRT
n=10 participants at risk
Pre-IMRT pazopanib 600 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Run-in 3) Pazopanib, Paclitaxel, IMRT
n=11 participants at risk
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Pazopanib, Paclitaxel, IMRT
n=36 participants at risk
Pre-IMRT pazopanib 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent pazopanib 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
(Phase II) Placebo, Paclitaxel, IMRT
n=34 participants at risk
Pre-IMRT placebo 400 mg suspension oral daily and paclitaxel 80 mg/m\^2 IV weekly for 2-3 weeks.
Concurrent placebo 300 mg suspension oral daily, paclitaxel 50 mg/m\^2 IV weekly during 6.5 weeks of IMRT.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
72.7%
8/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
60.0%
6/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
54.5%
6/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
41.7%
15/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
38.2%
13/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Cardiac disorders
Sinus tachycardia
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.8%
4/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Endocrine disorders
Endocrine disorders - Other
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.1%
4/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Eye disorders
Blurred vision
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Constipation
|
36.4%
4/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
30.0%
3/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
22.2%
8/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
29.4%
10/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Diarrhea
|
72.7%
8/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
50.0%
5/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
44.4%
16/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
17.6%
6/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Dry mouth
|
45.5%
5/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
80.0%
8/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
45.5%
5/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
47.2%
17/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
44.1%
15/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.8%
4/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Dysphagia
|
81.8%
9/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
70.0%
7/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
90.9%
10/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
77.8%
28/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
70.6%
24/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Esophageal obstruction
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Esophageal pain
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Esophageal stenosis
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
20.0%
2/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.3%
3/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
22.2%
8/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Mucositis oral
|
54.5%
6/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
70.0%
7/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
63.6%
7/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
50.0%
18/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
47.1%
16/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Nausea
|
54.5%
6/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
70.0%
7/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
54.5%
6/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
55.6%
20/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
64.7%
22/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.1%
4/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
14.7%
5/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.3%
3/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.8%
3/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Gastrointestinal disorders
Vomiting
|
45.5%
5/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
40.0%
4/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
27.8%
10/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
38.2%
13/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
General disorders
Chills
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
General disorders
Edema limbs
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
20.0%
2/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.1%
4/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
General disorders
Fatigue
|
90.9%
10/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
90.0%
9/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
81.8%
9/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
72.2%
26/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
70.6%
24/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
General disorders
Fever
|
45.5%
5/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.3%
3/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
14.7%
5/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
General disorders
Gait disturbance
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
22.2%
8/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
General disorders
Infusion related reaction
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
General disorders
Localized edema
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
General disorders
Neck edema
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
General disorders
Non-cardiac chest pain
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
General disorders
Pain
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
20.0%
2/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
16.7%
6/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
29.4%
10/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Infections and infestations
Infections and infestations - Other
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Infections and infestations
Lung infection
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.3%
3/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Infections and infestations
Mucosal infection
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.8%
3/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Infections and infestations
Skin infection
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
20.0%
2/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Infections and infestations
Wound infection
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
63.6%
7/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
100.0%
10/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
72.7%
8/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
61.1%
22/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
76.5%
26/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Alanine aminotransferase increased
|
54.5%
6/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
80.0%
8/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
45.5%
5/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
47.2%
17/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.8%
3/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Alkaline phosphatase increased
|
45.5%
5/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
40.0%
4/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
27.8%
10/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Aspartate aminotransferase increased
|
63.6%
7/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
70.0%
7/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
36.4%
4/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
50.0%
18/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.8%
4/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Blood bilirubin increased
|
45.5%
5/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
30.0%
3/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
22.2%
8/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Creatinine increased
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.8%
4/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
GGT increased
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
INR increased
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Investigations - Other
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Lymphocyte count decreased
|
72.7%
8/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
41.7%
15/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
35.3%
12/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Neutrophil count decreased
|
36.4%
4/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
40.0%
4/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
36.1%
13/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Platelet count decreased
|
54.5%
6/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
30.0%
3/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
25.0%
9/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.8%
3/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
Weight loss
|
54.5%
6/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
50.0%
5/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
36.4%
4/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
27.8%
10/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
35.3%
12/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Investigations
White blood cell decreased
|
72.7%
8/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
60.0%
6/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
36.4%
4/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
47.2%
17/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
17.6%
6/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Anorexia
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
50.0%
5/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
30.6%
11/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
35.3%
12/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Dehydration
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
20.0%
2/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
13.9%
5/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
17.6%
6/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.8%
3/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
72.7%
8/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
50.0%
5/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
30.6%
11/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
26.5%
9/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
16.7%
6/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.8%
3/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
54.5%
6/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
60.0%
6/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
27.8%
10/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
23.5%
8/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
63.6%
7/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
60.0%
6/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
33.3%
12/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
26.5%
9/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.3%
3/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
20.0%
2/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
19.4%
7/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.8%
3/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
30.0%
3/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.1%
4/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.8%
3/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
45.5%
5/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
30.0%
3/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
33.3%
12/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
14.7%
5/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
36.4%
4/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
20.0%
2/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.1%
4/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
16.7%
6/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.8%
3/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.8%
3/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.1%
4/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
38.9%
14/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
29.4%
10/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Musculoskeletal and connective tissue disorders
Neck soft tissue necrosis
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.3%
3/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Nervous system disorders
Dizziness
|
63.6%
7/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.1%
4/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Nervous system disorders
Dysgeusia
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
50.0%
5/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
38.9%
14/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
29.4%
10/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Nervous system disorders
Headache
|
36.4%
4/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
20.0%
2/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
14.7%
5/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Nervous system disorders
Memory impairment
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.8%
4/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Nervous system disorders
Paresthesia
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
54.5%
6/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
40.0%
4/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
22.2%
8/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.8%
4/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Nervous system disorders
Syncope
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Nervous system disorders
Tremor
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
26.5%
9/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.8%
3/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Psychiatric disorders
Insomnia
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
20.0%
2/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
17.6%
6/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Renal and urinary disorders
Proteinuria
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Renal and urinary disorders
Urinary frequency
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
63.6%
7/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
16.7%
6/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
26.5%
9/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
54.5%
6/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
19.4%
7/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
14.7%
5/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
36.4%
4/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
20.0%
2/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
36.4%
4/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
33.3%
12/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
38.2%
13/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.9%
2/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
20.0%
2/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.8%
3/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
30.0%
3/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
13.9%
5/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
17.6%
6/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
30.0%
3/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
14.7%
5/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
13.9%
5/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
45.5%
5/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
30.0%
3/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.3%
3/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.8%
4/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
20.0%
2/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.1%
4/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.3%
3/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
70.0%
7/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.1%
4/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.8%
3/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.3%
3/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.2%
2/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
20.0%
2/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.3%
3/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
27.3%
3/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.8%
3/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
27.8%
10/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
14.7%
5/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
20.0%
2/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.3%
3/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
10.0%
1/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.3%
3/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
30.0%
3/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.9%
1/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Vascular disorders
Flushing
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
2.8%
1/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Vascular disorders
Hypertension
|
81.8%
9/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
40.0%
4/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
54.5%
6/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
36.1%
13/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
47.1%
16/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Vascular disorders
Hypotension
|
9.1%
1/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
19.4%
7/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
8.8%
3/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
5.6%
2/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/10 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/11 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
0.00%
0/36 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
11.8%
4/34 • Weekly pre-IMRT and during IMRT, 2 weeks after IMRT, every months for years 1-2, every 6 months for year 3, then annually. Maximum follow-up time was 7.4 years for run-in arms and 4.2 years for phase II arms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60