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NCT00567567 · ADVERSE EVENTS

Adverse events

Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma · Source last updated 2022-04-28

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
Not reported
Other-event reporting threshold
0%

We've excluded the ineligibles from this table.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Single HST (CEM)

Induction therapy + single myeloablative consolidation

16 / 206196 / 206Not reported / Not reported
Tandem HST (CEM), Randomly Assigned

Induction therapy + tandem myeloablative consolidation

15 / 176163 / 176Not reported / Not reported
Not Assigned

Patients that either failed during Induction therapy or refused randomization

12 / 269230 / 269Not reported / Not reported

Group identifiers: EG000: Single HST (CEM) · EG001: Tandem HST (CEM), Randomly Assigned · EG002: Not Assigned

Serious adverse events

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

  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      269
      num Events
      2
    term
    13200-Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      176
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    17200-Blood and lymphatic system disorders - Other specify
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      206
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      269
      num Events
      1
    term
    25800-Disseminated intravascular coagulation
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      176
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    33300-Febrile neutropenia
  5. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    39600-Hemolysis
  6. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      269
      num Events
      1
    term
    39700-Hemolytic uremic syndrome
  7. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      206
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      269
      num Events
      1
    term
    20000-Cardiac arrest
  8. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      176
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    51700-Left ventricular systolic dysfunction
  9. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      176
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      269
      num Events
      2
    term
    63100-Pericardial effusion
  10. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      176
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    72700-Right ventricular dysfunction
  11. organ System
    Eye disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      176
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    31900-Eye disorders - Other specify
  12. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      206
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      176
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    14900-Ascites

Other reported adverse events

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

  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      206
      num Events
      35
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      176
      num Events
      37
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      269
      num Events
      42
    term
    13200-Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      176
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    17200-Blood and lymphatic system disorders - Other specify
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      206
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      269
      num Events
      1
    term
    25800-Disseminated intravascular coagulation
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      206
      num Events
      46
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      176
      num Events
      41
    3. group Id
      EG002
      num Affected
      46
      num At Risk
      269
      num Events
      53
    term
    33300-Febrile neutropenia
  5. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      269
      num Events
      1
    term
    20000-Cardiac arrest
  6. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      176
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    20100-Cardiac disorders - Other specify
  7. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    39000-Heart failure
  8. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      176
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    63100-Pericardial effusion
  9. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    72700-Right ventricular dysfunction
  10. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    27900-Ear and labyrinth disorders - Other specify
  11. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      206
      num Events
      6
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      176
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      269
      num Events
      3
    term
    38900-Hearing impaired
  12. organ System
    Endocrine disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      269
      num Events
      1
    term
    11200-Adrenal insufficiency
Complete source fields
description
We've excluded the ineligibles from this table.
event Groups
  1. description
    Induction therapy + single myeloablative consolidation
    id
    EG000
    other Num Affected
    196
    other Num At Risk
    206
    serious Num Affected
    16
    serious Num At Risk
    206
    title
    Single HST (CEM)
  2. description
    Induction therapy + tandem myeloablative consolidation
    id
    EG001
    other Num Affected
    163
    other Num At Risk
    176
    serious Num Affected
    15
    serious Num At Risk
    176
    title
    Tandem HST (CEM), Randomly Assigned
  3. description
    Patients that either failed during Induction therapy or refused randomization
    id
    EG002
    other Num Affected
    230
    other Num At Risk
    269
    serious Num Affected
    12
    serious Num At Risk
    269
    title
    Not Assigned
frequency Threshold
0
other Events
  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      206
      num Events
      35
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      176
      num Events
      37
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      269
      num Events
      42
    term
    13200-Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      176
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    17200-Blood and lymphatic system disorders - Other specify
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      206
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      269
      num Events
      1
    term
    25800-Disseminated intravascular coagulation
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      206
      num Events
      46
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      176
      num Events
      41
    3. group Id
      EG002
      num Affected
      46
      num At Risk
      269
      num Events
      53
    term
    33300-Febrile neutropenia
  5. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      269
      num Events
      1
    term
    20000-Cardiac arrest
  6. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      176
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    20100-Cardiac disorders - Other specify
  7. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    39000-Heart failure
  8. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      176
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    63100-Pericardial effusion
  9. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    72700-Right ventricular dysfunction
  10. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    27900-Ear and labyrinth disorders - Other specify
  11. organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      206
      num Events
      6
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      176
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      269
      num Events
      3
    term
    38900-Hearing impaired
  12. organ System
    Endocrine disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      269
      num Events
      1
    term
    11200-Adrenal insufficiency
serious Events
  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      269
      num Events
      2
    term
    13200-Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      176
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    17200-Blood and lymphatic system disorders - Other specify
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      206
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      269
      num Events
      1
    term
    25800-Disseminated intravascular coagulation
  4. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      176
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    33300-Febrile neutropenia
  5. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    39600-Hemolysis
  6. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      269
      num Events
      1
    term
    39700-Hemolytic uremic syndrome
  7. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      206
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      176
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      269
      num Events
      1
    term
    20000-Cardiac arrest
  8. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      176
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    51700-Left ventricular systolic dysfunction
  9. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      206
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      176
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      269
      num Events
      2
    term
    63100-Pericardial effusion
  10. organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      176
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    72700-Right ventricular dysfunction
  11. organ System
    Eye disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      206
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      176
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    31900-Eye disorders - Other specify
  12. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      206
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      176
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      269
      num Events
      0
    term
    14900-Ascites

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice