Trial Outcomes & Findings for A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma (NCT NCT03345095)

Last Updated: 2025-07-01

Results Overview

Overall Survival (OS): OS is defined as the number of days from date of randomization to the date of death due to any cause. If a patient has not died, the data will be censored at the last date documented to be alive.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

749 participants

Primary outcome timeframe

From the date of randomization up to the date of death, assessed up to 49 months

Results posted on

2025-07-01

Participant Flow

Patient registration was accepted from authorized investigators. Patients were registered on the Electronic Data Capture system. To access it, the investigator needed a user name and a password which were provided by the EORTC Headquarters. In case of problems investigators could contact the EORTC Clinical Data Manager. A Subject Identifier was allocated to the patient. This number allowed the identification of the patient in the Electronic Data Capture.

Eligibility criteria were checked at time of randomization. Once eligibility had been verified, treatment was randomly allocated to the patient, together with a sequential patient identification number. This number allowed the identification of the patients in the Electronic Data Capture system that was used to complete the Case Report Forms.

Participant milestones

Participant milestones
Measure	Experimental Arm Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib Marizomib: Intravenous administration of Marizomib Temozolomide: Oral Administration of Temozolomide radiotherapy: 60 Gy in 30 fractions over 6 weeks	Standard Arm Radiotherapy + Temozolomide followed by adjuvant Temozolomide Temozolomide: Oral Administration of Temozolomide radiotherapy: 60 Gy in 30 fractions over 6 weeks
Overall Study STARTED	374	375
Overall Study COMPLETED	125	8
Overall Study NOT COMPLETED	249	367

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Arm Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib Marizomib: Intravenous administration of Marizomib Temozolomide: Oral Administration of Temozolomide radiotherapy: 60 Gy in 30 fractions over 6 weeks	Standard Arm Radiotherapy + Temozolomide followed by adjuvant Temozolomide Temozolomide: Oral Administration of Temozolomide radiotherapy: 60 Gy in 30 fractions over 6 weeks
Overall Study Lack of Efficacy	184	156
Overall Study Adverse Event	36	118
Overall Study Withdrawal by Subject	22	59
Overall Study Physician Decision	3	18
Overall Study Death	2	4
Overall Study Other reasons	2	11
Overall Study Protocol Violation	0	1

Baseline Characteristics

A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Arm n=374 Participants Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib Marizomib: Intravenous administration of Marizomib Temozolomide: Oral Administration of Temozolomide radiotherapy: 60 Gy in 30 fractions over 6 weeks	Standard Arm n=375 Participants Radiotherapy + Temozolomide followed by adjuvant Temozolomide Temozolomide: Oral Administration of Temozolomide radiotherapy: 60 Gy in 30 fractions over 6 weeks	Total n=749 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	287 Participants n=5 Participants	276 Participants n=7 Participants	563 Participants n=5 Participants
Age, Categorical >=65 years	87 Participants n=5 Participants	99 Participants n=7 Participants	186 Participants n=5 Participants
Age, Continuous	58.5 years n=5 Participants	58.0 years n=7 Participants	58.0 years n=5 Participants
Sex: Female, Male Female	119 Participants n=5 Participants	142 Participants n=7 Participants	261 Participants n=5 Participants
Sex: Female, Male Male	255 Participants n=5 Participants	233 Participants n=7 Participants	488 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	279 Participants n=5 Participants	290 Participants n=7 Participants	569 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	85 Participants n=5 Participants	79 Participants n=7 Participants	164 Participants n=5 Participants
Region of Enrollment Canada	104 participants n=5 Participants	108 participants n=7 Participants	212 participants n=5 Participants
Region of Enrollment Austria	6 participants n=5 Participants	7 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment Netherlands	45 participants n=5 Participants	44 participants n=7 Participants	89 participants n=5 Participants
Region of Enrollment Belgium	30 participants n=5 Participants	32 participants n=7 Participants	62 participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	19 participants n=7 Participants	40 participants n=5 Participants
Region of Enrollment Norway	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Denmark	9 participants n=5 Participants	10 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment United Kingdom	8 participants n=5 Participants	7 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment France	55 participants n=5 Participants	54 participants n=7 Participants	109 participants n=5 Participants
Region of Enrollment Switzerland	20 participants n=5 Participants	24 participants n=7 Participants	44 participants n=5 Participants
Region of Enrollment Germany	38 participants n=5 Participants	37 participants n=7 Participants	75 participants n=5 Participants
Region of Enrollment Spain	34 participants n=5 Participants	29 participants n=7 Participants	63 participants n=5 Participants
Karnofsky Performance Status 70/80	126 Participants n=5 Participants	123 Participants n=7 Participants	249 Participants n=5 Participants
Karnofsky Performance Status 90/100	248 Participants n=5 Participants	252 Participants n=7 Participants	500 Participants n=5 Participants
Extent of surgery Gross total	192 Participants n=5 Participants	192 Participants n=7 Participants	384 Participants n=5 Participants
Extent of surgery Partial/biopsy	182 Participants n=5 Participants	183 Participants n=7 Participants	365 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the date of randomization up to the date of death, assessed up to 49 months

Population: Analysis population is Intention-to-treat population (ITT): All randomized patients will be analyzed in the arm they were allocated by randomization

Outcome measures

Outcome measures
Measure	Experimental Arm n=309 Participants Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib Marizomib: Intravenous administration of Marizomib Temozolomide: Oral Administration of Temozolomide radiotherapy: 60 Gy in 30 fractions over 6 weeks	Standard Arm n=307 Participants Radiotherapy + Temozolomide followed by adjuvant Temozolomide Temozolomide: Oral Administration of Temozolomide radiotherapy: 60 Gy in 30 fractions over 6 weeks
Overall Survival (OS)	16.13 Months Interval 14.92 to 17.77	15.08 Months Interval 13.73 to 16.99

SECONDARY outcome

Timeframe: From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first, assessed up to 49 months

Population: The analysis population is Intention-to-treat population (ITT): All randomized patients will be analyzed in the arm they were allocated by randomization.

PFS is defined as the number of days from date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology criteria (by investigator) or to the date of death due to any cause, if disease progression does not occur. Patients for whom neither death nor progression have been documented were censored on the date of the last radiological assessment that the patient was progression-free. If a patient with no post-baseline radiological assessment then the data were censored at the date of randomization. Patients with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where the patient was documented to be progression free. Patients who received new anti-cancer therapy or cancer-related surgery prior to progression or death were not censored at the last assessment where the patient was documented as progression free prior to the new therapy.

Outcome measures

Outcome measures
Measure	Experimental Arm n=309 Participants Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib Marizomib: Intravenous administration of Marizomib Temozolomide: Oral Administration of Temozolomide radiotherapy: 60 Gy in 30 fractions over 6 weeks	Standard Arm n=307 Participants Radiotherapy + Temozolomide followed by adjuvant Temozolomide Temozolomide: Oral Administration of Temozolomide radiotherapy: 60 Gy in 30 fractions over 6 weeks
Progression Free Survival (PFS)	6.34 Months Interval 5.82 to 7.85	6.11 Months Interval 4.93 to 7.29

SECONDARY outcome

Timeframe: From randomization until progression or death which ever occurs first, reported at week 16 by the mean difference from baseline assessment.

Population: At week 16 during the TMZ maintenance phase, HRQol was obtained from 212 patients in the Experimental arm and 207 patients in the Standard arm.

HRQoL was assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) version 3. The primary HRQol score is Physical Functioning. It is reported at week 16 during the Temozolomide (TMZ) maintenance phase. Physical functioning score is ranging 0 to 100. A large scores indicate a good physical functioning. A negative difference indicates a worsening physical functioning.

Outcome measures

Outcome measures
Measure	Experimental Arm n=212 Participants Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib Marizomib: Intravenous administration of Marizomib Temozolomide: Oral Administration of Temozolomide radiotherapy: 60 Gy in 30 fractions over 6 weeks	Standard Arm n=207 Participants Radiotherapy + Temozolomide followed by adjuvant Temozolomide Temozolomide: Oral Administration of Temozolomide radiotherapy: 60 Gy in 30 fractions over 6 weeks
Health-related Quality of Life (HRQol)	-11.8 score on a scale Interval -15.0 to -8.7	-5.4 score on a scale Interval -8.0 to -2.9

SECONDARY outcome

Timeframe: From the date of randomization until end of treatment. It is reported at week 16 by the mean difference from baseline assessment.

Population: At week 16 during the TMZ maintenance phase, HRQol was obtained from 180 patients in the Experimental arm and 166 patients in the Standard arm.

MMSE is a brief, standardized tool to grade patients' neurocognitive function. It is an 11-question measure that tests five areas of neurocognitive function: orientation, registration, attention and calculation, recall, and language. A large MMSE score indicates a good cognitive functioning. The maximum MMSE score is 30 which corresponds to the best neurocognitive function and minimum MMSE score is 0 the worst neurocognitive function.The patient's neurocognitive function are considered 'impaired' if MMSE is 26 or less and 'normal' if it is 27 or more. MMSE has been validated and extensively used in both clinical practice and research. It is reported at week 16 during the Temozolomide (TMZ) maintenance phase. A negative difference indicates a worsening cognitive functioning. Difference range reported in the data table is min -19 and max 10. The mean difference is reported with 95% confidence interval (CI). A CI which excludes 0 indicates a significant mean MMSE score change.

Outcome measures

Outcome measures
Measure	Experimental Arm n=180 Participants Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib Marizomib: Intravenous administration of Marizomib Temozolomide: Oral Administration of Temozolomide radiotherapy: 60 Gy in 30 fractions over 6 weeks	Standard Arm n=166 Participants Radiotherapy + Temozolomide followed by adjuvant Temozolomide Temozolomide: Oral Administration of Temozolomide radiotherapy: 60 Gy in 30 fractions over 6 weeks
Mini Mental State Examination (MMSE)	-0.95 score on a scale Interval -1.51 to -0.38	-0.39 score on a scale Interval -0.82 to 0.04

Adverse Events

Experimental Arm

Serious events: 114 serious events

Other events: 300 other events

Deaths: 55 deaths

Standard Arm

Serious events: 80 serious events

Other events: 283 other events

Deaths: 57 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Thierry Gorlia

EORTC

Phone: +32 2 7741652

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Experimental Arm n=305 participants at risk Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib Marizomib: Intravenous administration of Marizomib Temozolomide: Oral Administration of Temozolomide radiotherapy: 60 Gy in 30 fractions over 6 weeks	Standard Arm n=297 participants at risk Radiotherapy + Temozolomide followed by adjuvant Temozolomide Temozolomide: Oral Administration of Temozolomide radiotherapy: 60 Gy in 30 fractions over 6 weeks
Blood and lymphatic system disorders Anaemia	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Febrile Neutropenia	0.00% 0/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Leukopenia	0.66% 2/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Neutropenia	0.98% 3/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Pancytopenia	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Thrombocytopenia	2.3% 7/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Angina Pectoris	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Atrial Flutter	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Diplopia	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Colitis	0.00% 0/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Diarrhoea	0.66% 2/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Enterocolitis	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Gastritis	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Inflammation	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Nausea	2.3% 7/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Upper Gastrointestinal Haemorrhage	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Vomiting	1.6% 5/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.67% 2/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Catheter Site Thrombosis	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Fatigue	1.3% 4/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Gait Disturbance	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.67% 2/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 General Physical Health Deterioration	1.3% 4/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	1.7% 5/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Impaired Healing	0.00% 0/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Influenza Like Illness	0.00% 0/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Oedema Peripheral	0.00% 0/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Peripheral Swelling	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Pyrexia	0.66% 2/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	1.0% 3/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Vascular Device Occlusion	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Drug-Induced Liver Injury	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Anal Abscess	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Bacterial Infection	0.00% 0/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Brain Abscess	0.00% 0/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Covid-19	0.00% 0/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Cystitis	0.66% 2/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Cytomegalovirus Infection	0.00% 0/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Device Related Infection	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Device Related Sepsis	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Enterocolitis Infectious	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Gastroenteritis Viral	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Herpes Zoster Infection Neurological	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Influenza	0.00% 0/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	Experimental Arm n=305 participants at risk Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib Marizomib: Intravenous administration of Marizomib Temozolomide: Oral Administration of Temozolomide radiotherapy: 60 Gy in 30 fractions over 6 weeks	Standard Arm n=297 participants at risk Radiotherapy + Temozolomide followed by adjuvant Temozolomide Temozolomide: Oral Administration of Temozolomide radiotherapy: 60 Gy in 30 fractions over 6 weeks
Blood and lymphatic system disorders Anaemia	5.2% 16/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	6.1% 18/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Febrile Neutropenia	0.00% 0/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Leukopenia	2.6% 8/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	2.0% 6/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Lymphopenia	5.9% 18/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	6.1% 18/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Neutropenia	4.3% 13/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	3.7% 11/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Pancytopenia	0.66% 2/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Thrombocytopenia	8.9% 27/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	9.8% 29/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Angina Pectoris	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Atrial Fibrillation	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Atrial Flutter	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Failure	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Palpitations	1.6% 5/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.67% 2/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Sinus Bradycardia	0.00% 0/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Sinus Tachycardia	0.66% 2/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.67% 2/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Supraventricular Tachycardia	0.00% 0/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Tachycardia	0.66% 2/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Deafness	0.00% 0/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	1.0% 3/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Ear Congestion	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Ear Discomfort	1.3% 4/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Ear Pain	1.6% 5/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	1.0% 3/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Hyperacusis	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Hypoacusis	2.3% 7/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Presbyacusis	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Tinnitus	3.6% 11/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	1.7% 5/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Vertigo	8.2% 25/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	1.0% 3/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Vestibular Disorder	0.66% 2/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Cushing's Syndrome	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Cushingoid	2.3% 7/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	1.7% 5/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Altered Visual Depth Perception	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Asthenopia	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Blindness	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Cataract	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.67% 2/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Diplopia	7.2% 22/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.67% 2/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Dry Eye	1.3% 4/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Dyschromatopsia	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Eye Discharge	0.33% 1/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Eye Inflammation	0.00% 0/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Eye Irritation	0.66% 2/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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% 0/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Eye Pain	0.66% 2/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	1.0% 3/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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 Eye Paraesthesia	0.00% 0/305 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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	0.34% 1/297 • Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study. Both serious and non-serious AEs were collected. We reported serious adverse events (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