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NCT00103259 · ADVERSE EVENTS

Adverse events

Bortezomib With or Without Irinotecan in Treating Patients With Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck · Source last updated 2014-05-23

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
Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Other-event reporting threshold
5%

All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Bortezomib+Irinotecan)

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

17 / 2323 / 23Not reported / Not reported
Arm II (Bortezomib)

Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).

21 / 4140 / 41Not reported / Not reported
Cross-over Patients

11 patients crossed over to bortezomib + irinotecan after progressed on bortezomib single agent. Adverse events were reported for the 11 patients while receiving the combination therapy.

6 / 1111 / 11Not reported / Not reported

Group identifiers: EG000: Arm I (Bortezomib+Irinotecan) · EG001: Arm II (Bortezomib) · EG002: Cross-over Patients

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
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    term
    Leukopenia (Leukocytes decreased)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Neutropenia (Neutrophils decreased)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Thrombocytopenia (Platelets decreased)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Hypotension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Fever w/o neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Insomnia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Constitutional, other
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    term
    Anorexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Constipation

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
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      11
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      11
    term
    Leukopenia (Leukocytes decreased)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    term
    Neutropenia (Neutrophils decreased)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      11
    term
    Thrombocytopenia (Platelets decreased)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Hematologic-other
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    term
    Hypotension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      11
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Fever w/o neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    term
    Insomnia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    term
    Weight loss
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    term
    Constitutional, other
Complete source fields
description
All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
event Groups
  1. description
    Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    23
    other Num At Risk
    23
    serious Num Affected
    17
    serious Num At Risk
    23
    title
    Arm I (Bortezomib+Irinotecan)
  2. description
    Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
    id
    EG001
    other Num Affected
    40
    other Num At Risk
    41
    serious Num Affected
    21
    serious Num At Risk
    41
    title
    Arm II (Bortezomib)
  3. description
    11 patients crossed over to bortezomib + irinotecan after progressed on bortezomib single agent. Adverse events were reported for the 11 patients while receiving the combination therapy.
    id
    EG002
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    6
    serious Num At Risk
    11
    title
    Cross-over Patients
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      11
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      11
    term
    Leukopenia (Leukocytes decreased)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    term
    Neutropenia (Neutrophils decreased)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      11
    term
    Thrombocytopenia (Platelets decreased)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Hematologic-other
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    term
    Hypotension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      11
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Fever w/o neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    term
    Insomnia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    term
    Weight loss
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    term
    Constitutional, other
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    term
    Leukopenia (Leukocytes decreased)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Neutropenia (Neutrophils decreased)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Thrombocytopenia (Platelets decreased)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Hypotension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Fever w/o neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Insomnia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Constitutional, other
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    term
    Anorexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    term
    Constipation
time Frame
Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.

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Preserved source evidence · Not medical advice