Trial Outcomes & Findings for Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH) (NCT NCT00626990)
NCT ID: NCT00626990
Last Updated: 2023-09-11
Results Overview
The duration of survival is the time interval between randomization and the date of death due to any cause. Patients not reported dead or lost to follow up will be censored at the date of the last follow up examination.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
751 participants
Primary outcome timeframe
from date from enrollment till the date of death (time till death is up to 10.9 years after patient enrollment in the study)
Results posted on
2023-09-11
Participant Flow
After registration step was completed, eligible patients were randomized into the trial within 8 days from the start of radiotherapy; at this time, all baseline requirements for the study had to be fulfilled.
The patients were first registered to the trial by authorized sites. For all patients, tumor and blood samples had to be sent for histology review, 1p/19q analysis and O6-Methylguanine-DNA Methyltransferase (MGMT) assay. If inclusion was based on central pathology and 1p/19q diagnosis the patient could be randomized into the trial once found eligible at central assessment.
Participant milestones
| Measure |
RT Alone
radiation therapy alone
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
RT & Concurrent CT
Radiotherapy and concurrent temozolomide chemotherapy
temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
RT + Adjuvant CT
Radiotherapy plus adjuvant temozolomide chemotherapy
temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
RT & Concurrent CT + Adjuvant CT
Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy
temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
189
|
188
|
186
|
188
|
|
Overall Study
COMPLETED
|
175
|
163
|
109
|
93
|
|
Overall Study
NOT COMPLETED
|
14
|
25
|
77
|
95
|
Reasons for withdrawal
| Measure |
RT Alone
radiation therapy alone
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
RT & Concurrent CT
Radiotherapy and concurrent temozolomide chemotherapy
temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
RT + Adjuvant CT
Radiotherapy plus adjuvant temozolomide chemotherapy
temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
RT & Concurrent CT + Adjuvant CT
Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy
temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
6
|
7
|
49
|
40
|
|
Overall Study
Adverse Event
|
1
|
7
|
14
|
28
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
5
|
11
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
0
|
|
Overall Study
Various different reasons/missing
|
4
|
8
|
8
|
16
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
RT Alone
n=189 Participants
radiation therapy alone
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
RT & Concurrent CT
n=188 Participants
Radiotherapy and concurrent temozolomide chemotherapy
temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
RT + Adjuvant CT
n=186 Participants
Radiotherapy plus adjuvant temozolomide chemotherapy
temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
RT & Concurrent CT + Adjuvant CT
n=188 Participants
Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy
temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
Total
n=751 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Region of Enrollment
Belgium
|
19 participants
n=189 Participants
|
20 participants
n=188 Participants
|
16 participants
n=186 Participants
|
18 participants
n=188 Participants
|
73 participants
n=751 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=189 Participants
|
0 Participants
n=188 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=188 Participants
|
0 Participants
n=751 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
174 Participants
n=189 Participants
|
168 Participants
n=188 Participants
|
174 Participants
n=186 Participants
|
180 Participants
n=188 Participants
|
696 Participants
n=751 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=189 Participants
|
20 Participants
n=188 Participants
|
12 Participants
n=186 Participants
|
8 Participants
n=188 Participants
|
55 Participants
n=751 Participants
|
|
Age, Continuous
|
42 years
n=189 Participants
|
43.1 years
n=188 Participants
|
40 years
n=186 Participants
|
42.8 years
n=188 Participants
|
42.2 years
n=751 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=189 Participants
|
68 Participants
n=188 Participants
|
82 Participants
n=186 Participants
|
82 Participants
n=188 Participants
|
307 Participants
n=751 Participants
|
|
Sex: Female, Male
Male
|
114 Participants
n=189 Participants
|
120 Participants
n=188 Participants
|
104 Participants
n=186 Participants
|
106 Participants
n=188 Participants
|
444 Participants
n=751 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
6 participants
n=189 Participants
|
5 participants
n=188 Participants
|
6 participants
n=186 Participants
|
6 participants
n=188 Participants
|
23 participants
n=751 Participants
|
|
Region of Enrollment
Netherlands
|
19 participants
n=189 Participants
|
20 participants
n=188 Participants
|
19 participants
n=186 Participants
|
14 participants
n=188 Participants
|
72 participants
n=751 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=189 Participants
|
22 participants
n=188 Participants
|
21 participants
n=186 Participants
|
28 participants
n=188 Participants
|
101 participants
n=751 Participants
|
|
Region of Enrollment
Italy
|
13 participants
n=189 Participants
|
10 participants
n=188 Participants
|
16 participants
n=186 Participants
|
11 participants
n=188 Participants
|
50 participants
n=751 Participants
|
|
Region of Enrollment
United Kingdom
|
31 participants
n=189 Participants
|
39 participants
n=188 Participants
|
39 participants
n=186 Participants
|
34 participants
n=188 Participants
|
143 participants
n=751 Participants
|
|
Region of Enrollment
Australia
|
14 participants
n=189 Participants
|
22 participants
n=188 Participants
|
21 participants
n=186 Participants
|
25 participants
n=188 Participants
|
82 participants
n=751 Participants
|
|
Region of Enrollment
France
|
26 participants
n=189 Participants
|
23 participants
n=188 Participants
|
22 participants
n=186 Participants
|
22 participants
n=188 Participants
|
93 participants
n=751 Participants
|
|
Region of Enrollment
Switzerland
|
5 participants
n=189 Participants
|
7 participants
n=188 Participants
|
7 participants
n=186 Participants
|
7 participants
n=188 Participants
|
26 participants
n=751 Participants
|
|
Region of Enrollment
Germany
|
22 participants
n=189 Participants
|
13 participants
n=188 Participants
|
17 participants
n=186 Participants
|
18 participants
n=188 Participants
|
70 participants
n=751 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=189 Participants
|
6 participants
n=188 Participants
|
1 participants
n=186 Participants
|
3 participants
n=188 Participants
|
14 participants
n=751 Participants
|
|
Region of Enrollment
Turkey
|
0 participants
n=189 Participants
|
1 participants
n=188 Participants
|
1 participants
n=186 Participants
|
2 participants
n=188 Participants
|
4 participants
n=751 Participants
|
|
Presence of oligodendroglial elements
No
|
146 Participants
n=189 Participants
|
144 Participants
n=188 Participants
|
143 Participants
n=186 Participants
|
144 Participants
n=188 Participants
|
577 Participants
n=751 Participants
|
|
Presence of oligodendroglial elements
Yes
|
43 Participants
n=189 Participants
|
44 Participants
n=188 Participants
|
43 Participants
n=186 Participants
|
44 Participants
n=188 Participants
|
174 Participants
n=751 Participants
|
|
World Health Organization (WHO) Performance Status
ECOG performance status 0 (good prognosis)
|
111 Participants
n=189 Participants
|
110 Participants
n=188 Participants
|
108 Participants
n=186 Participants
|
112 Participants
n=188 Participants
|
441 Participants
n=751 Participants
|
|
World Health Organization (WHO) Performance Status
ECOG performance status >0 (poorer prognosis)
|
78 Participants
n=189 Participants
|
78 Participants
n=188 Participants
|
78 Participants
n=186 Participants
|
76 Participants
n=188 Participants
|
310 Participants
n=751 Participants
|
|
Procedure for pathology and genetic testing
by local site laboratory assessment
|
70 Participants
n=189 Participants
|
70 Participants
n=188 Participants
|
68 Participants
n=186 Participants
|
54 Participants
n=188 Participants
|
262 Participants
n=751 Participants
|
|
Procedure for pathology and genetic testing
by central laboratory assessment
|
119 Participants
n=189 Participants
|
118 Participants
n=188 Participants
|
116 Participants
n=186 Participants
|
134 Participants
n=188 Participants
|
487 Participants
n=751 Participants
|
|
Procedure for pathology and genetic testing
Unknown
|
0 Participants
n=189 Participants
|
0 Participants
n=188 Participants
|
2 Participants
n=186 Participants
|
0 Participants
n=188 Participants
|
2 Participants
n=751 Participants
|
|
Presence of 1p LOH
No loss
|
175 Participants
n=189 Participants
|
176 Participants
n=188 Participants
|
172 Participants
n=186 Participants
|
175 Participants
n=188 Participants
|
698 Participants
n=751 Participants
|
|
Presence of 1p LOH
Loss
|
14 Participants
n=189 Participants
|
12 Participants
n=188 Participants
|
14 Participants
n=186 Participants
|
13 Participants
n=188 Participants
|
53 Participants
n=751 Participants
|
|
MGMT Methylation status
Methylated
|
62 Participants
n=189 Participants
|
55 Participants
n=188 Participants
|
66 Participants
n=186 Participants
|
56 Participants
n=188 Participants
|
239 Participants
n=751 Participants
|
|
MGMT Methylation status
Unmethylated
|
83 Participants
n=189 Participants
|
79 Participants
n=188 Participants
|
78 Participants
n=186 Participants
|
87 Participants
n=188 Participants
|
327 Participants
n=751 Participants
|
|
MGMT Methylation status
Undetermined/invalid
|
44 Participants
n=189 Participants
|
54 Participants
n=188 Participants
|
42 Participants
n=186 Participants
|
45 Participants
n=188 Participants
|
185 Participants
n=751 Participants
|
PRIMARY outcome
Timeframe: from date from enrollment till the date of death (time till death is up to 10.9 years after patient enrollment in the study)Population: This trial studied 2 questions 1) effect of concomitant Temozolomide (TMZ) 2) effect of adjuvant TMZ. The 4 randomized arms were combined. Absence of concomitant TMZ including Arm Radiotherapy (RT) alone \& Arm RT followed by adjuvant TMZ. Presence of concomitant TMZ including Arm TMZ/RT \& Arm TMZ/RT followed by adjuvant TMZ. Absence of adjuvant TMZ including Arm RT alone \& Arm TMZ/RT. Presence of adjuvant TMZ including Arm RT followed by adjuvant TMZ \& Arm TMZ/RT followed by adjuvant TMZ
The duration of survival is the time interval between randomization and the date of death due to any cause. Patients not reported dead or lost to follow up will be censored at the date of the last follow up examination.
Outcome measures
| Measure |
Absence of Concomitant Temozolomide (TMZ)
n=375 Participants
Including 2 randomized arms: Arm RT alone and Arm RT followed by adjuvant TMZ
|
Presence of Concomitant Temozolomide (TMZ)
n=376 Participants
Including 2 randomized arms: Arm TMZ/RT and Arm TMZ/RT followed by adjuvant TMZ
|
Absence of Adjuvant Temozolomide (TMZ)
n=377 Participants
Including two randomized arms: Arm RT alone and Arm TMZ/RT
|
Presence of Adjuvant Temozolomide (TMZ)
n=374 Participants
Including to 2 randomized arms: Arm RT followed by adjuvant TMZ and Arm TMZ/RT followed by adjuvant TMZ
|
|---|---|---|---|---|
|
Overall Survival as Measured From the Day of Randomization
|
60.42 Months
Interval 45.7 to 71.49
|
66.92 Months
Interval 48.53 to 82.33
|
46.92 Months
Interval 37.88 to 56.94
|
82.33 Months
Interval 67.19 to 116.63
|
SECONDARY outcome
Timeframe: from randomization till the date of disease progression or death (time till death is up to 10.9 years after patient enrollment in the study)Population: This trial studied separately two questions 1) effect of concomitant TMZ 2) effect of adjuvant TMZ. The 4 randomized arms were combined before analysis. Absence of concomitant TMZ including Arm RT alone \& Arm RT followed by adjuvant TMZ. Presence of concomitant TMZ including Arm TMZ/RT \& Arm TMZ/RT followed by adjuvant TMZ. Absence of adjuvant TMZ including Arm RT alone \& Arm TMZ/RT. Presence of adjuvant TMZ including Arm RT followed by adjuvant TMZ \& Arm TMZ/RT followed by adjuvant TMZ
Disease progression is defined as radiological or neurological/clinical progression (whichever occurs first); progression free survival (PFS) is the time interval between the date of randomization and the date of disease progression or death whichever occurs first. If neither event has been observed, the patient is censored at the date of the last follow up examination. Radiological progression was defined as increase of contrast enhancing area on MRI or CT scans of more than 25% as measured by two perpendicular diameters compared to the smallest measurements ever recorded for the same lesion by the same technique. The appearance of new lesions with or without contrast enhancement Neurological/clinical progression was defined as:decrease in WHO performance status,deterioration of neurological functions,appearance of signs/symptoms of increased intracranial pressure,and/or start of corticosteroid or increase of corticosteroid dosage by 50% for control of neurological symptoms.
Outcome measures
| Measure |
Absence of Concomitant Temozolomide (TMZ)
n=375 Participants
Including 2 randomized arms: Arm RT alone and Arm RT followed by adjuvant TMZ
|
Presence of Concomitant Temozolomide (TMZ)
n=376 Participants
Including 2 randomized arms: Arm TMZ/RT and Arm TMZ/RT followed by adjuvant TMZ
|
Absence of Adjuvant Temozolomide (TMZ)
n=377 Participants
Including two randomized arms: Arm RT alone and Arm TMZ/RT
|
Presence of Adjuvant Temozolomide (TMZ)
n=374 Participants
Including to 2 randomized arms: Arm RT followed by adjuvant TMZ and Arm TMZ/RT followed by adjuvant TMZ
|
|---|---|---|---|---|
|
Progression-free Survival
|
20.9 Months
Interval 17.25 to 26.64
|
33.02 Months
Interval 23.82 to 46.06
|
19.09 Months
Interval 14.59 to 23.82
|
42.81 Months
Interval 27.83 to 56.44
|
SECONDARY outcome
Timeframe: from 14 days prior to randomization till five years or death (time till death is up to 10.9 years after patient enrollment in the study)Quality of life was assessed by the EORTC Quality of Life Questionnaire (QLQ-C30) version 3 and the Brain Cancer Module-20
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: within 2 weeks of randomization; during radiotherapy at week 4 and 6; 4 weeks after the end of radiotherapy; Six monthly after the end of radiotherapy; Prior to each cycle of adjuvant therapy; Every six months after the documentation of first progression.Neurological deterioration is defined as a decrease in WHO performance status as follows: decrease in WHO performance status * for patients with baseline WHO performance status 0: deterioration to WHO performance status 2 or worse for which no other explanation is present, and which is maintained for at least three months * for patients with baseline WHO performance status 1 or 2: deterioration to WHO performance status 3 or worse for which no other explanation is present and which is maintained for at least three months The date of neurological deterioration will be the first date the persistent decrease in performance status was diagnosed. Neurological deterioration free progression is the time interval between the date of randomization and the date of neurological deterioration or death whichever occurs first. If neither event has been observed, the patient is censored at the date of the last follow up examination
Outcome measures
Outcome data not reported
Adverse Events
RT Alone
Serious events: 13 serious events
Other events: 182 other events
Deaths: 107 deaths
RT & Concurrent CT
Serious events: 27 serious events
Other events: 183 other events
Deaths: 97 deaths
RT + Adjuvant CT
Serious events: 32 serious events
Other events: 182 other events
Deaths: 78 deaths
RT & Concurrent CT + Adjuvant CT
Serious events: 32 serious events
Other events: 185 other events
Deaths: 74 deaths
Serious adverse events
| Measure |
RT Alone
n=186 participants at risk
radiation therapy alone
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
RT & Concurrent CT
n=185 participants at risk
Radiotherapy and concurrent temozolomide chemotherapy
temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
RT + Adjuvant CT
n=183 participants at risk
Radiotherapy plus adjuvant temozolomide chemotherapy
temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
RT & Concurrent CT + Adjuvant CT
n=185 participants at risk
Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy
temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
|---|---|---|---|---|
|
Vascular disorders
VASCULAR
|
0.00%
0/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.54%
1/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.55%
1/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Immune system disorders
ALLERGY/IMMUNOLOGY
|
0.00%
0/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
1.1%
2/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
1.1%
2/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
General disorders
CONSTITUTIONAL SYMPTOMS
|
0.00%
0/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
3.8%
7/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
1.1%
2/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
1.1%
2/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
General disorders
PAIN
|
1.1%
2/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
1.1%
2/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
2.2%
4/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
1.6%
3/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Cardiac disorders
CARDIAC(GENERAL)
|
0.54%
1/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.54%
1/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Blood and lymphatic system disorders
BLOOD
|
1.1%
2/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
1.1%
2/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
1.1%
2/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
2.7%
5/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Blood and lymphatic system disorders
LYMPHATICS
|
1.1%
2/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.55%
1/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY
|
0.00%
0/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.54%
1/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Nervous system disorders
NEUROLOGY
|
4.8%
9/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
8.1%
15/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
6.6%
12/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
5.4%
10/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Eye disorders
OCULAR/VISUAL
|
0.00%
0/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
1.1%
2/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.54%
1/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Gastrointestinal disorders
GASTROINTESTINAL
|
0.54%
1/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
1.1%
2/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
2.2%
4/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
2.7%
5/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Renal and urinary disorders
RENAL/GENITOURINARY
|
0.00%
0/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.55%
1/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.54%
1/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN
|
0.54%
1/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
1.1%
2/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
1.1%
2/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE
|
0.00%
0/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.55%
1/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY
|
0.54%
1/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
1.1%
2/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.55%
1/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.54%
1/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Infections and infestations
INFECTION
|
3.2%
6/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
2.2%
4/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
4.4%
8/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
3.2%
6/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
Other adverse events
| Measure |
RT Alone
n=186 participants at risk
radiation therapy alone
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
RT & Concurrent CT
n=185 participants at risk
Radiotherapy and concurrent temozolomide chemotherapy
temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
RT + Adjuvant CT
n=183 participants at risk
Radiotherapy plus adjuvant temozolomide chemotherapy
temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
RT & Concurrent CT + Adjuvant CT
n=185 participants at risk
Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy
temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.
DNA methylation analysis: MGMT methylation status is used for stratification at randomization.
laboratory biomarker analysis: Prognostic factor analyses
adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.
quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression
radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
|
|---|---|---|---|---|
|
Vascular disorders
VASCULAR
|
1.1%
2/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
3.8%
7/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
2.7%
5/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
3.8%
7/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Surgical and medical procedures
SURGERY/INTRA-OPERATIVE INJURY
|
0.00%
0/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Immune system disorders
ALLERGY/IMMUNOLOGY
|
3.8%
7/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
4.9%
9/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
6.0%
11/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
4.9%
9/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
General disorders
CONSTITUTIONAL SYMPTOMS
|
81.2%
151/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
86.5%
160/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
92.9%
170/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
86.5%
160/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
General disorders
PAIN
|
69.4%
129/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
70.8%
131/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
75.4%
138/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
70.8%
131/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Reproductive system and breast disorders
SEXUAL/REPRODUCTIVE FUNCTION
|
1.1%
2/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
2.2%
4/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
3.8%
7/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
2.2%
4/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Cardiac disorders
CARDIAC(GENERAL)
|
4.8%
9/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
8.1%
15/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
9.3%
17/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
8.1%
15/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY
|
4.3%
8/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
4.9%
9/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
9.3%
17/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
4.9%
9/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Blood and lymphatic system disorders
BLOOD
|
2.7%
5/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
6.5%
12/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
5.5%
10/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
6.5%
12/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Blood and lymphatic system disorders
LYMPHATICS
|
6.5%
12/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
5.4%
10/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
7.7%
14/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
5.4%
10/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Nervous system disorders
NEUROLOGY
|
79.0%
147/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
82.7%
153/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
80.9%
148/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
82.7%
153/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Eye disorders
OCULAR/VISUAL
|
27.4%
51/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
33.5%
62/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
26.2%
48/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
33.5%
62/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Ear and labyrinth disorders
AUDITORY/EAR
|
16.1%
30/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
12.4%
23/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
18.0%
33/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
12.4%
23/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Gastrointestinal disorders
GASTROINTESTINAL
|
57.5%
107/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
73.5%
136/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
86.3%
158/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
73.5%
136/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Renal and urinary disorders
RENAL/GENITOURINARY
|
5.9%
11/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
3.8%
7/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
8.7%
16/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
3.8%
7/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Hepatobiliary disorders
HEPATOBILIAR/PANCREAS
|
0.00%
0/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
0.00%
0/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN
|
78.5%
146/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
75.1%
139/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
80.3%
147/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
75.1%
139/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE
|
8.6%
16/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
9.2%
17/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
12.6%
23/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
9.2%
17/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Endocrine disorders
ENDOCRINE
|
3.2%
6/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
4.3%
8/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
4.9%
9/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
4.3%
8/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY
|
3.8%
7/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
3.8%
7/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
4.4%
8/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
3.8%
7/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
|
Infections and infestations
INFECTION
|
19.9%
37/186 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
18.9%
35/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
39.3%
72/183 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
18.9%
35/185 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place