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NCT00626990 · ADVERSE EVENTS

Adverse events

Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH) · Source last updated 2023-09-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.
Other-event reporting threshold
0%

Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
RT Alone

radiation therapy alone DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule

13 / 186182 / 186107 / 189
RT & Concurrent CT

Radiotherapy and concurrent temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule

27 / 185183 / 18597 / 188
RT + Adjuvant CT

Radiotherapy plus adjuvant temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy. quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule

32 / 183182 / 18378 / 186
RT & Concurrent CT + Adjuvant CT

Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy. quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule

32 / 185185 / 18574 / 188

Group identifiers: EG000: RT Alone · EG001: RT & Concurrent CT · EG002: RT + Adjuvant CT · EG003: RT & Concurrent CT + Adjuvant CT

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    term
    VASCULAR
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      185
    term
    ALLERGY/IMMUNOLOGY
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      185
    term
    CONSTITUTIONAL SYMPTOMS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      185
    term
    PAIN
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      185
    term
    CARDIAC(GENERAL)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      185
    term
    BLOOD
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    term
    LYMPHATICS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      185
    term
    PULMONARY/UPPER RESPIRATORY
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      185
    term
    NEUROLOGY
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      185
    term
    OCULAR/VISUAL
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      185
    term
    GASTROINTESTINAL
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      185
    term
    RENAL/GENITOURINARY

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      185
    term
    VASCULAR
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    term
    SURGERY/INTRA-OPERATIVE INJURY
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      185
    term
    ALLERGY/IMMUNOLOGY
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      151
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      160
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      170
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      160
      num At Risk
      185
    term
    CONSTITUTIONAL SYMPTOMS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      129
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      131
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      138
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      131
      num At Risk
      185
    term
    PAIN
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      185
    term
    SEXUAL/REPRODUCTIVE FUNCTION
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      185
    term
    CARDIAC(GENERAL)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      185
    term
    PULMONARY/UPPER RESPIRATORY
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      185
    term
    BLOOD
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      185
    term
    LYMPHATICS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      147
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      153
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      148
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      153
      num At Risk
      185
    term
    NEUROLOGY
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      48
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      62
      num At Risk
      185
    term
    OCULAR/VISUAL
Complete source fields
description
Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments
event Groups
  1. deaths Num Affected
    107
    deaths Num At Risk
    189
    description
    radiation therapy alone DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
    id
    EG000
    other Num Affected
    182
    other Num At Risk
    186
    serious Num Affected
    13
    serious Num At Risk
    186
    title
    RT Alone
  2. deaths Num Affected
    97
    deaths Num At Risk
    188
    description
    Radiotherapy and concurrent temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
    id
    EG001
    other Num Affected
    183
    other Num At Risk
    185
    serious Num Affected
    27
    serious Num At Risk
    185
    title
    RT & Concurrent CT
  3. deaths Num Affected
    78
    deaths Num At Risk
    186
    description
    Radiotherapy plus adjuvant temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy. quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
    id
    EG002
    other Num Affected
    182
    other Num At Risk
    183
    serious Num Affected
    32
    serious Num At Risk
    183
    title
    RT + Adjuvant CT
  4. deaths Num Affected
    74
    deaths Num At Risk
    188
    description
    Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy. quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
    id
    EG003
    other Num Affected
    185
    other Num At Risk
    185
    serious Num Affected
    32
    serious Num At Risk
    185
    title
    RT & Concurrent CT + Adjuvant CT
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      185
    term
    VASCULAR
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Surgical and medical procedures
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    term
    SURGERY/INTRA-OPERATIVE INJURY
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      185
    term
    ALLERGY/IMMUNOLOGY
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      151
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      160
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      170
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      160
      num At Risk
      185
    term
    CONSTITUTIONAL SYMPTOMS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      129
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      131
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      138
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      131
      num At Risk
      185
    term
    PAIN
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      185
    term
    SEXUAL/REPRODUCTIVE FUNCTION
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      185
    term
    CARDIAC(GENERAL)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      185
    term
    PULMONARY/UPPER RESPIRATORY
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      185
    term
    BLOOD
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      185
    term
    LYMPHATICS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      147
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      153
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      148
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      153
      num At Risk
      185
    term
    NEUROLOGY
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      48
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      62
      num At Risk
      185
    term
    OCULAR/VISUAL
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    term
    VASCULAR
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      185
    term
    ALLERGY/IMMUNOLOGY
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      185
    term
    CONSTITUTIONAL SYMPTOMS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      185
    term
    PAIN
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      185
    term
    CARDIAC(GENERAL)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      185
    term
    BLOOD
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      185
    term
    LYMPHATICS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      185
    term
    PULMONARY/UPPER RESPIRATORY
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      185
    term
    NEUROLOGY
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      185
    term
    OCULAR/VISUAL
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      185
    term
    GASTROINTESTINAL
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      186
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      183
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      185
    term
    RENAL/GENITOURINARY
time Frame
Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study.

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Preserved source evidence · Not medical advice