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NCT00549848 · ADVERSE EVENTS

Adverse events

Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia · Source last updated 2022-08-23

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
Through 1 month after therapy completion, approximately 25 months
Other-event reporting threshold
5%

Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
PEG 3500 Units/m^2

Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase

0 / 206206 / 2069 / 206
PEG 2500 Units/m^2

Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase

0 / 208208 / 20815 / 208
Not Randomized

Patients who came off study prior to randomization

2 / 184184 / 18422 / 184

Group identifiers: EG000: PEG 3500 Units/m^2 · EG001: PEG 2500 Units/m^2 · EG002: Not Randomized

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 Version 3.0
    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
      208
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      184
      num Events
      1
    term
    Thrombosis/thrombus/embolism
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE Version 3.0
    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
      208
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      184
      num Events
      1
    term
    Infection, Blood

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
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      206
      num Events
      36
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      208
      num Events
      35
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      184
      num Events
      20
    term
    Allergic reaction to Asparaginase
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      206
      num Events
      58
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      208
      num Events
      56
    3. group Id
      EG002
      num Affected
      58
      num At Risk
      184
      num Events
      66
    term
    Hypertension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      206
      num Events
      17
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      208
      num Events
      23
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      184
      num Events
      13
    term
    Hypotension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      156
      num At Risk
      206
      num Events
      395
    2. group Id
      EG001
      num Affected
      147
      num At Risk
      208
      num Events
      381
    3. group Id
      EG002
      num Affected
      116
      num At Risk
      184
      num Events
      283
    term
    Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      206
      num Events
      22
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      208
      num Events
      11
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      184
      num Events
      14
    term
    Dehydration
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      206
      num Events
      19
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      208
      num Events
      13
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      184
      num Events
      12
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      206
      num Events
      64
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      208
      num Events
      78
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      184
      num Events
      46
    term
    Mucositis/stomatitis (functional/symptomatic), Oral cavity
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      206
      num Events
      25
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      208
      num Events
      37
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      184
      num Events
      21
    term
    Typhlitis (cecal inflammation)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      206
      num Events
      17
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      208
      num Events
      18
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      184
      num Events
      18
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      206
      num Events
      17
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      208
      num Events
      24
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      184
      num Events
      44
    term
    Pancreatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      83
      num At Risk
      206
      num Events
      168
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      208
      num Events
      103
    3. group Id
      EG002
      num Affected
      55
      num At Risk
      184
      num Events
      113
    term
    Colitis, infectious (e.g., Clostridium difficile)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      163
      num At Risk
      206
      num Events
      392
    2. group Id
      EG001
      num Affected
      160
      num At Risk
      208
      num Events
      404
    3. group Id
      EG002
      num Affected
      124
      num At Risk
      184
      num Events
      239
    term
    Febrile neutropenia
Complete source fields
description
Systemic assessment was used for collection of adverse events including: * Real time reporting of significant events by treating team * Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting) * Biweekly review of AEs by PI and treating team for accuracy and completion
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    206
    description
    Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
    id
    EG000
    other Num Affected
    206
    other Num At Risk
    206
    serious Num Affected
    0
    serious Num At Risk
    206
    title
    PEG 3500 Units/m^2
  2. deaths Num Affected
    15
    deaths Num At Risk
    208
    description
    Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
    id
    EG001
    other Num Affected
    208
    other Num At Risk
    208
    serious Num Affected
    0
    serious Num At Risk
    208
    title
    PEG 2500 Units/m^2
  3. deaths Num Affected
    22
    deaths Num At Risk
    184
    description
    Patients who came off study prior to randomization
    id
    EG002
    other Num Affected
    184
    other Num At Risk
    184
    serious Num Affected
    2
    serious Num At Risk
    184
    title
    Not Randomized
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      206
      num Events
      36
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      208
      num Events
      35
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      184
      num Events
      20
    term
    Allergic reaction to Asparaginase
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      206
      num Events
      58
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      208
      num Events
      56
    3. group Id
      EG002
      num Affected
      58
      num At Risk
      184
      num Events
      66
    term
    Hypertension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      206
      num Events
      17
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      208
      num Events
      23
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      184
      num Events
      13
    term
    Hypotension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      156
      num At Risk
      206
      num Events
      395
    2. group Id
      EG001
      num Affected
      147
      num At Risk
      208
      num Events
      381
    3. group Id
      EG002
      num Affected
      116
      num At Risk
      184
      num Events
      283
    term
    Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      206
      num Events
      22
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      208
      num Events
      11
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      184
      num Events
      14
    term
    Dehydration
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      206
      num Events
      19
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      208
      num Events
      13
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      184
      num Events
      12
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      206
      num Events
      64
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      208
      num Events
      78
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      184
      num Events
      46
    term
    Mucositis/stomatitis (functional/symptomatic), Oral cavity
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      206
      num Events
      25
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      208
      num Events
      37
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      184
      num Events
      21
    term
    Typhlitis (cecal inflammation)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      206
      num Events
      17
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      208
      num Events
      18
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      184
      num Events
      18
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      206
      num Events
      17
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      208
      num Events
      24
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      184
      num Events
      44
    term
    Pancreatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      83
      num At Risk
      206
      num Events
      168
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      208
      num Events
      103
    3. group Id
      EG002
      num Affected
      55
      num At Risk
      184
      num Events
      113
    term
    Colitis, infectious (e.g., Clostridium difficile)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE Version 3.0
    stats
    1. group Id
      EG000
      num Affected
      163
      num At Risk
      206
      num Events
      392
    2. group Id
      EG001
      num Affected
      160
      num At Risk
      208
      num Events
      404
    3. group Id
      EG002
      num Affected
      124
      num At Risk
      184
      num Events
      239
    term
    Febrile neutropenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE Version 3.0
    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
      208
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      184
      num Events
      1
    term
    Thrombosis/thrombus/embolism
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE Version 3.0
    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
      208
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      184
      num Events
      1
    term
    Infection, Blood
time Frame
Through 1 month after therapy completion, approximately 25 months

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