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NCT00573989 · ADVERSE EVENTS

Adverse events

Intensity-Modulated Radiation Therapy, Pemetrexed, and Erlotinib in Treating Patients With Recurrent or Second Primary Head and Neck Cancer · Source last updated 2019-01-03

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
up to 5 years
Other-event reporting threshold
5%

All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Erlotinib 100 mg

Participants will be given 100mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.

3 / 44 / 44 / 4
Erlotinib 125mg

Participants will be given 125mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.

6 / 66 / 66 / 6
Erlotinib 150mg

Participants will be given 150mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.

5 / 55 / 55 / 5
Erlotinib 125mg Phase II

Participants in phase II will be given 125mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.

5 / 1111 / 118 / 12

Group identifiers: EG000: Erlotinib 100 mg · EG001: Erlotinib 125mg · EG002: Erlotinib 150mg · EG003: Erlotinib 125mg Phase II

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 (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Hypoxia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (ANC/AGC) 1.6-7.3
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    term
    Neutrophils/granulocytes
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Trachea
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Obstruction/stenosis of airway
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    creatine phosphokinase
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    CPK
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    hypocalcemia
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Calcium, serum-low
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Cardiac ischemia/infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    cTnI
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Cardiac troponin I
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    non-fatal
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Cardiopulmonary arrest, cause unknown
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (total WBC) (4.8-10.8)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    term
    Leukocytes
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Cardiac/heart
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (metabolic or respiratory) (7.35-7.45)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Acidosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Other
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Gastrointestinal

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
    notes
    (serum glutamic pyruvic transaminase) ((2 -50)
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      11
    term
    ALT, SGPT
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (serum glutamic oxaloacetic transaminase) (5-40)
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      11
    term
    AST, SGOT
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (hypoalbuminemia) (3.5-5.0)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      11
    term
    Albumin, serum-low
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (25-125)
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      11
    term
    Alkaline phosphatase
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (including sneezing, nasal stuffiness, postnasal drip)
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    term
    Allergic rhinitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    term
    Anorexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (non-septic)
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    term
    Arthritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (hyperbilirubinemia) (0.1-1.2)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      11
    term
    Bilirubin
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (hypocalcemia)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      11
    term
    Calcium, serum-low
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Other
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    term
    Cardiac General
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    range of motion
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    term
    Cervical spine
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      11
    term
    Constipation
Complete source fields
description
All-Cause Mortality data was collected for all 12 participants in the "Erlotinib 125mg Phase II" Arm/Group, while Serious Adverse Events and Other (Not Including Serious) Adverse Events data were only collected for 11 participants in this Arm/group
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    4
    description
    Participants will be given 100mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    Erlotinib 100 mg
  2. deaths Num Affected
    6
    deaths Num At Risk
    6
    description
    Participants will be given 125mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    6
    serious Num At Risk
    6
    title
    Erlotinib 125mg
  3. deaths Num Affected
    5
    deaths Num At Risk
    5
    description
    Participants will be given 150mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    5
    serious Num At Risk
    5
    title
    Erlotinib 150mg
  4. deaths Num Affected
    8
    deaths Num At Risk
    12
    description
    Participants in phase II will be given 125mg of erlotinib, pemetrexed disodium, and intensity-modulated radiation therapy.
    id
    EG003
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    5
    serious Num At Risk
    11
    title
    Erlotinib 125mg Phase II
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (serum glutamic pyruvic transaminase) ((2 -50)
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      11
    term
    ALT, SGPT
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (serum glutamic oxaloacetic transaminase) (5-40)
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      11
    term
    AST, SGOT
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (hypoalbuminemia) (3.5-5.0)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      11
    term
    Albumin, serum-low
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (25-125)
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      11
    term
    Alkaline phosphatase
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (including sneezing, nasal stuffiness, postnasal drip)
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    term
    Allergic rhinitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    term
    Anorexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (non-septic)
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    term
    Arthritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (hyperbilirubinemia) (0.1-1.2)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      11
    term
    Bilirubin
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (hypocalcemia)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      11
    term
    Calcium, serum-low
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Other
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    term
    Cardiac General
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    range of motion
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    term
    Cervical spine
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      11
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Hypoxia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (ANC/AGC) 1.6-7.3
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    term
    Neutrophils/granulocytes
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Trachea
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Obstruction/stenosis of airway
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    creatine phosphokinase
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    CPK
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    hypocalcemia
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Calcium, serum-low
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Cardiac ischemia/infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    cTnI
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Cardiac troponin I
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    non-fatal
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Cardiopulmonary arrest, cause unknown
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (total WBC) (4.8-10.8)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    term
    Leukocytes
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Cardiac/heart
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    (metabolic or respiratory) (7.35-7.45)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Acidosis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Other
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Gastrointestinal
time Frame
up to 5 years

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Preserved source evidence · Not medical advice