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NCT02112916 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma · Source last updated 2026-07-29

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
3 years from start of therapy by patient
Other-event reporting threshold
0%

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (Combination Chemotherapy): T-ALL

Patients receive combination chemotherapy without bortezomib.

56 / 308231 / 30838 / 308
Arm B (Combination Chemotherapy, Bortezomib): T-ALL

Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification)

153 / 307217 / 30738 / 307
Arm A (Combination Chemotherapy): T-LLy

Patients receive combination chemotherapy without bortezomib.

25 / 10886 / 10823 / 108
Arm B (Combination Chemotherapy, Bortezomib): T-LLy

Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification)

60 / 10174 / 1019 / 101

Group identifiers: EG000: Arm A (Combination Chemotherapy): T-ALL · EG001: Arm B (Combination Chemotherapy, Bortezomib): T-ALL · EG002: Arm A (Combination Chemotherapy): T-LLy · EG003: Arm B (Combination Chemotherapy, Bortezomib): T-LLy

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      307
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      101
      num Events
      2
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Bone marrow hypocellular
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      307
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    Disseminated intravascular coagulation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      308
      num Events
      12
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      307
      num Events
      51
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      108
      num Events
      3
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      101
      num Events
      20
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Hemolysis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      307
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      108
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      308
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      101
      num Events
      2
    term
    Heart failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Left ventricular systolic dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Sinus bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    Sinus tachycardia

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      308
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      307
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      308
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Bone marrow hypocellular
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    Disseminated intravascular coagulation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      308
      num Events
      20
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      307
      num Events
      29
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      108
      num Events
      11
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      101
      num Events
      9
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Left ventricular systolic dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      308
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Pericardial effusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Pericardial tamponade
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Sinus bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      307
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Supraventricular tachycardia
Complete source fields
description
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
event Groups
  1. deaths Num Affected
    38
    deaths Num At Risk
    308
    description
    Patients receive combination chemotherapy without bortezomib.
    id
    EG000
    other Num Affected
    231
    other Num At Risk
    308
    serious Num Affected
    56
    serious Num At Risk
    308
    title
    Arm A (Combination Chemotherapy): T-ALL
  2. deaths Num Affected
    38
    deaths Num At Risk
    307
    description
    Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification)
    id
    EG001
    other Num Affected
    217
    other Num At Risk
    307
    serious Num Affected
    153
    serious Num At Risk
    307
    title
    Arm B (Combination Chemotherapy, Bortezomib): T-ALL
  3. deaths Num Affected
    23
    deaths Num At Risk
    108
    description
    Patients receive combination chemotherapy without bortezomib.
    id
    EG002
    other Num Affected
    86
    other Num At Risk
    108
    serious Num Affected
    25
    serious Num At Risk
    108
    title
    Arm A (Combination Chemotherapy): T-LLy
  4. deaths Num Affected
    9
    deaths Num At Risk
    101
    description
    Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification)
    id
    EG003
    other Num Affected
    74
    other Num At Risk
    101
    serious Num Affected
    60
    serious Num At Risk
    101
    title
    Arm B (Combination Chemotherapy, Bortezomib): T-LLy
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      308
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      307
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      308
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Bone marrow hypocellular
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    Disseminated intravascular coagulation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      308
      num Events
      20
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      307
      num Events
      29
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      108
      num Events
      11
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      101
      num Events
      9
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Left ventricular systolic dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      308
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Pericardial effusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Pericardial tamponade
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Sinus bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      307
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Supraventricular tachycardia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      307
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      101
      num Events
      2
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Bone marrow hypocellular
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      307
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    Disseminated intravascular coagulation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      308
      num Events
      12
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      307
      num Events
      51
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      108
      num Events
      3
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      101
      num Events
      20
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Hemolysis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      307
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      108
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      308
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      101
      num Events
      2
    term
    Heart failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Left ventricular systolic dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      308
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    Sinus bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCv4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      308
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    Sinus tachycardia
time Frame
3 years from start of therapy by patient

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Preserved source evidence · Not medical advice