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NCT00873093 · ADVERSE EVENTS

Adverse events

Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma · Source last updated 2017-01-27

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%

SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs

Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.

2 / 44 / 4Not reported / Not reported
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs

Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.

47 / 6158 / 61Not reported / Not reported
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs

Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.

40 / 4944 / 49Not reported / Not reported
T-cell ALL (Chemotherapy)

Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.

18 / 2221 / 22Not reported / Not reported
T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.

7 / 109 / 10Not reported / Not reported

Group identifiers: EG000: Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs · EG001: Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs · EG002: Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs · EG003: T-cell ALL (Chemotherapy) · EG004: T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

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
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Disseminated intravascular coagulation
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      61
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      49
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      22
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Febrile neutropenia
  4. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      61
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Cardiac arrest
  5. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      49
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Cardiac disorders - Other, specify
  6. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Heart failure
  7. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Left ventricular systolic dysfunction
  8. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Pericardial tamponade
  9. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Sinus bradycardia
  10. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Sinus tachycardia
  11. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Ventricular tachycardia
  12. organ System
    Eye disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Eye pain

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
      3
      num At Risk
      4
      num Events
      3
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      61
      num Events
      47
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      49
      num Events
      29
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      22
      num Events
      17
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      10
      num Events
      7
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    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
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      61
      num Events
      23
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      49
      num Events
      22
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      22
      num Events
      10
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    Febrile neutropenia
  4. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Pericardial effusion
  5. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Ventricular tachycardia
  6. organ System
    Eye disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Conjunctivitis
  7. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal distension
  8. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      61
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal pain
  9. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Anal fistula
  10. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Anal pain
  11. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Ascites
  12. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Colitis
Complete source fields
description
SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
event Groups
  1. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs
  2. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    EG001
    other Num Affected
    58
    other Num At Risk
    61
    serious Num Affected
    47
    serious Num At Risk
    61
    title
    Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs
  3. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    EG002
    other Num Affected
    44
    other Num At Risk
    49
    serious Num Affected
    40
    serious Num At Risk
    49
    title
    Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs
  4. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    EG003
    other Num Affected
    21
    other Num At Risk
    22
    serious Num Affected
    18
    serious Num At Risk
    22
    title
    T-cell ALL (Chemotherapy)
  5. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    EG004
    other Num Affected
    9
    other Num At Risk
    10
    serious Num Affected
    7
    serious Num At Risk
    10
    title
    T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
frequency Threshold
0
other Events
  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      3
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      61
      num Events
      47
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      49
      num Events
      29
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      22
      num Events
      17
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      10
      num Events
      7
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      22
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    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
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      61
      num Events
      23
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      49
      num Events
      22
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      22
      num Events
      10
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    Febrile neutropenia
  4. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Pericardial effusion
  5. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Ventricular tachycardia
  6. organ System
    Eye disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Conjunctivitis
  7. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal distension
  8. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      61
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal pain
  9. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Anal fistula
  10. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Anal pain
  11. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Ascites
  12. organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Colitis
serious Events
  1. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Disseminated intravascular coagulation
  3. organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      61
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      49
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      22
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Febrile neutropenia
  4. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      61
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Cardiac arrest
  5. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      49
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Cardiac disorders - Other, specify
  6. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Heart failure
  7. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Left ventricular systolic dysfunction
  8. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Pericardial tamponade
  9. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Sinus bradycardia
  10. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      61
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      49
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Sinus tachycardia
  11. organ System
    Cardiac disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Ventricular tachycardia
  12. organ System
    Eye disorders
    source Vocabulary
    CTCV4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      61
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      49
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      22
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Eye pain

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Preserved source evidence · Not medical advice