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NCT00667342 · ADVERSE EVENTS

Adverse events

A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma · Source last updated 2023-08-07

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 were recorded from on-study date through April 2015.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
A: Localized Resectable Disease

Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.

3 / 3131 / 31Not reported / Not reported
C: Metastatic Tumors

Stratum C participants had metastatic tumors.

0 / 1111 / 11Not reported / Not reported

Group identifiers: EG000: A: Localized Resectable Disease · EG001: C: Metastatic Tumors

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
    Cardiac disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hypotension
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Cognitive disturbance
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Encephalopathy
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Neuropathy: motor
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Neuropathy: sensory
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hypoxia

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
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      31
      num Events
      291
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      11
      num Events
      90
    term
    ALT, SGPT (serum glutamic pyruvic transaminase)
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      31
      num Events
      258
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      11
      num Events
      90
    term
    Albumin, serum-low (hypoalbuminemia)
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      31
      num Events
      255
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      11
      num Events
      135
    term
    Hemoglobin
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      31
      num Events
      230
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      11
      num Events
      123
    term
    Leukocytes (total WBC)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      31
      num Events
      212
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      11
      num Events
      137
    term
    Platelets
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      31
      num Events
      296
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      11
      num Events
      91
    term
    AST, SGOT (serum glutamic oxaloacetic transaminase)
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      31
      num Events
      75
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      11
      num Events
      21
    term
    Glucose, serum-high (hyperglycemia)
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      31
      num Events
      144
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      11
      num Events
      71
    term
    Phosphate, serum-low (hypophosphatemia)
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      31
      num Events
      101
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      11
      num Events
      39
    term
    Mucositis/stomatitis (clinical exam), oral cavity
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      31
      num Events
      173
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      11
      num Events
      65
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      31
      num Events
      148
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      11
      num Events
      47
    term
    Vomiting
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      31
      num Events
      106
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      11
      num Events
      38
    term
    Hemorrhage, pulmonary/upper respiratory, Nose
Complete source fields
event Groups
  1. description
    Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
    id
    EG000
    other Num Affected
    31
    other Num At Risk
    31
    serious Num Affected
    3
    serious Num At Risk
    31
    title
    A: Localized Resectable Disease
  2. description
    Stratum C participants had metastatic tumors.
    id
    EG001
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    0
    serious Num At Risk
    11
    title
    C: Metastatic Tumors
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      31
      num Events
      291
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      11
      num Events
      90
    term
    ALT, SGPT (serum glutamic pyruvic transaminase)
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      31
      num Events
      258
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      11
      num Events
      90
    term
    Albumin, serum-low (hypoalbuminemia)
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      31
      num Events
      255
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      11
      num Events
      135
    term
    Hemoglobin
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      31
      num Events
      230
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      11
      num Events
      123
    term
    Leukocytes (total WBC)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      31
      num Events
      212
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      11
      num Events
      137
    term
    Platelets
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      31
      num Events
      296
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      11
      num Events
      91
    term
    AST, SGOT (serum glutamic oxaloacetic transaminase)
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      31
      num Events
      75
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      11
      num Events
      21
    term
    Glucose, serum-high (hyperglycemia)
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      31
      num Events
      144
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      11
      num Events
      71
    term
    Phosphate, serum-low (hypophosphatemia)
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      31
      num Events
      101
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      11
      num Events
      39
    term
    Mucositis/stomatitis (clinical exam), oral cavity
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      31
      num Events
      173
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      11
      num Events
      65
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      31
      num Events
      148
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      11
      num Events
      47
    term
    Vomiting
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      31
      num Events
      106
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      11
      num Events
      38
    term
    Hemorrhage, pulmonary/upper respiratory, Nose
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hypotension
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Cognitive disturbance
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Encephalopathy
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
    term
    Neuropathy: motor
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Neuropathy: sensory
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hypoxia
time Frame
Adverse events were recorded from on-study date through April 2015.

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