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NCT02612194 · ADVERSE EVENTS

Adverse events

LCI-GU-URO-CRI-001: Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer · Source last updated 2022-11-03

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
Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal.
Other-event reporting threshold
0%

Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1

c-MET high (\> 50%), RON null (0-9%) Crizotinib: All arms will receive crizotinib.

2 / 65 / 65 / 6
Cohort 2

c-MET + (10-100%), RON + (10-100%) Crizotinib: All arms will receive crizotinib.

0 / 00 / 00 / 0
Cohort 3

c-MET null (0-9%), RON + (10-100%) Crizotinib: All arms will receive crizotinib.

2 / 22 / 22 / 2
Total

Pooled Cohorts 1, 2, and 3

4 / 87 / 87 / 8

Group identifiers: EG000: Cohort 1 · EG001: Cohort 2 · EG002: Cohort 3 · EG003: Total

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
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Back pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Confusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Dehydration
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Fever
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Hyponatremia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      8
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Respiratory failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Sepsis

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
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Alkaline phosphatase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Allergic rhinitis
  4. assessment Type
    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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      8
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Bloating
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Blurred vision
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Confusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      8
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Creatinine increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Dehydration
Complete source fields
description
Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    6
    description
    c-MET high (\> 50%), RON null (0-9%) Crizotinib: All arms will receive crizotinib.
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Cohort 1
  2. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    c-MET + (10-100%), RON + (10-100%) Crizotinib: All arms will receive crizotinib.
    id
    EG001
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Cohort 2
  3. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    c-MET null (0-9%), RON + (10-100%) Crizotinib: All arms will receive crizotinib.
    id
    EG002
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    Cohort 3
  4. deaths Num Affected
    7
    deaths Num At Risk
    8
    description
    Pooled Cohorts 1, 2, and 3
    id
    EG003
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    4
    serious Num At Risk
    8
    title
    Total
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Alkaline phosphatase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Allergic rhinitis
  4. assessment Type
    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
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      8
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Bloating
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Blurred vision
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Confusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      8
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Creatinine increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Dehydration
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Back pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Confusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Dehydration
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Fever
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Hyponatremia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      8
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Respiratory failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      8
    term
    Sepsis
time Frame
Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal.

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Preserved source evidence · Not medical advice