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NCT01344018 · ADVERSE EVENTS

Adverse events

Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma · Source last updated 2023-04-24

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
Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.
Other-event reporting threshold
0%

Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)

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

En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated. therapeutic conventional surgery

37 / 128124 / 12822 / 133
Preoperative Radiotherapy Followed by En-bloc Surgery

3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions therapeutic conventional surgery 3-dimensional conformal radiation therapy

48 / 127127 / 12725 / 133

Group identifiers: EG000: Surgery Alone · EG001: Preoperative Radiotherapy Followed by En-bloc Surgery

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      127
      num Events
      3
    term
    ANAEMIA
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    ARRHYTHMIA
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      127
      num Events
      2
    term
    CARDIAC ARREST
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
      num Events
      0
    term
    TACHYCARDIA
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    ABDOMINAL ADHESIONS
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
      num Events
      0
    term
    ABDOMINAL HERNIA
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      2
    term
    ABDOMINAL PAIN
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      127
      num Events
      3
    term
    ASCITES
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      127
      num Events
      2
    term
    CONSTIPATION
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    CROHN'S DISEASE
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    DIAPHRAGMATIC HERNIA, OBSTRUCTIVE
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    DIARRHOEA

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      127
      num Events
      5
    term
    ANEMIA
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    ATRIAL FIBRILLATION
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    CAR OTH ARRHYTHMIA
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
      num Events
      0
    term
    CAR OTH TACHYCARDIA, PT ON CHEMOTHERAPY, NOT RELATED TO PRIMARY DISEASE TX
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      127
      num Events
      3
    term
    CARDIAC ARREST
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
      num Events
      0
    term
    MYOCARDIAL INFARCTION
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    SINUS BRADYCARDIA
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
      num Events
      0
    term
    SINUS TACHYCARDIA
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    EAR PAIN
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      3
    term
    HEARING IMPAIRED
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    VERTIGO
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
      num Events
      0
    term
    ADRENAL INSUFFICIENCY
Complete source fields
description
Patient population: * all cause mortality: all patients * serious and non-serious adverse events: safety population consisting of all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation)
event Groups
  1. deaths Num Affected
    22
    deaths Num At Risk
    133
    description
    En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated. therapeutic conventional surgery
    id
    EG000
    other Num Affected
    124
    other Num At Risk
    128
    serious Num Affected
    37
    serious Num At Risk
    128
    title
    Surgery Alone
  2. deaths Num Affected
    25
    deaths Num At Risk
    133
    description
    3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions therapeutic conventional surgery 3-dimensional conformal radiation therapy
    id
    EG001
    other Num Affected
    127
    other Num At Risk
    127
    serious Num Affected
    48
    serious Num At Risk
    127
    title
    Preoperative Radiotherapy Followed by En-bloc Surgery
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      127
      num Events
      5
    term
    ANEMIA
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    ATRIAL FIBRILLATION
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    CAR OTH ARRHYTHMIA
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
      num Events
      0
    term
    CAR OTH TACHYCARDIA, PT ON CHEMOTHERAPY, NOT RELATED TO PRIMARY DISEASE TX
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      127
      num Events
      3
    term
    CARDIAC ARREST
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
      num Events
      0
    term
    MYOCARDIAL INFARCTION
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    SINUS BRADYCARDIA
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
      num Events
      0
    term
    SINUS TACHYCARDIA
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    EAR PAIN
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      3
    term
    HEARING IMPAIRED
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    VERTIGO
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
      num Events
      0
    term
    ADRENAL INSUFFICIENCY
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      127
      num Events
      3
    term
    ANAEMIA
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    ARRHYTHMIA
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      127
      num Events
      2
    term
    CARDIAC ARREST
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
      num Events
      0
    term
    TACHYCARDIA
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    ABDOMINAL ADHESIONS
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      128
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      127
      num Events
      0
    term
    ABDOMINAL HERNIA
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      2
    term
    ABDOMINAL PAIN
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      127
      num Events
      3
    term
    ASCITES
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      127
      num Events
      2
    term
    CONSTIPATION
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    CROHN'S DISEASE
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    DIAPHRAGMATIC HERNIA, OBSTRUCTIVE
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE_v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      128
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      127
      num Events
      1
    term
    DIARRHOEA
time Frame
Arm 1: within 21 days before randomization, 15 and 60 days after surgery, 14, 24, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death. Arm 2: within 21 days before randomization, weekly during the preoperative period, 2 weeks after end of RT, 15 days after surgery, 24 weeks after randomization, 60 days after surgery, 36 and 48 weeks after randomization and (after week 48 after randomization) every 6 months until recurrence/death.

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