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NCT01822496 · ADVERSE EVENTS

Adverse events

Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer · Source last updated 2019-08-05

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
From randomization to last follow-up. Maximum follow-up was 39.0 months.
Other-event reporting threshold
5%

Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
EGFR: Erlotinib

Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.

1 / 1414 / 141 / 14
EGFR: No Erlotinib

Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.

7 / 2020 / 203 / 20
ALK: Crizotinib

Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.

4 / 98 / 92 / 9
ALK: No Crizotinib

Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.

2 / 77 / 71 / 7

Group identifiers: EG000: EGFR: Erlotinib · EG001: EGFR: No Erlotinib · EG002: ALK: Crizotinib · EG003: ALK: No Crizotinib

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Atrial fibrillation
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Diarrhea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Esophageal fistula
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Esophageal stenosis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Esophagitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Vomiting
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Fatigue
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Fever
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    General disorders and administration site conditions - Other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Lung infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Alanine aminotransferase increased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Alkaline phosphatase increased

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      7
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Blood and lymphatic system disorders - Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Chest pain - cardiac
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Palpitations
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Sinus bradycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Sinus tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Hearing impaired
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Tinnitus
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Vertigo
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Endocrine disorders - Other
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Hypothyroidism
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Blurred vision
Complete source fields
description
Eligible patients who started treatment are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    14
    description
    Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
    id
    EG000
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    1
    serious Num At Risk
    14
    title
    EGFR: Erlotinib
  2. deaths Num Affected
    3
    deaths Num At Risk
    20
    description
    Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
    id
    EG001
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    7
    serious Num At Risk
    20
    title
    EGFR: No Erlotinib
  3. deaths Num Affected
    2
    deaths Num At Risk
    9
    description
    Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
    id
    EG002
    other Num Affected
    8
    other Num At Risk
    9
    serious Num Affected
    4
    serious Num At Risk
    9
    title
    ALK: Crizotinib
  4. deaths Num Affected
    1
    deaths Num At Risk
    7
    description
    Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
    id
    EG003
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    2
    serious Num At Risk
    7
    title
    ALK: No Crizotinib
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      7
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Blood and lymphatic system disorders - Other
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Chest pain - cardiac
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Palpitations
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Sinus bradycardia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Sinus tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Hearing impaired
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Tinnitus
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Vertigo
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Endocrine disorders - Other
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Hypothyroidism
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Blurred vision
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Atrial fibrillation
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Diarrhea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Esophageal fistula
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Esophageal stenosis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Esophagitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Vomiting
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Fatigue
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Fever
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    General disorders and administration site conditions - Other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
    term
    Lung infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Alanine aminotransferase increased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      9
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
    term
    Alkaline phosphatase increased
time Frame
From randomization to last follow-up. Maximum follow-up was 39.0 months.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice