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NCT02301039 · ADVERSE EVENTS

Adverse events

SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas · Source last updated 2020-09-29

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
Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.
Other-event reporting threshold
1%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Soft Tissue Sarcoma

Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks Pembrolizumab

19 / 4240 / 424 / 42
Bone Sarcoma

Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab will be administered at 200 mg intravenously every 3 weeks Pembrolizumab

15 / 4242 / 422 / 42
Expansion

Patients with the following types of soft tissue sarcoma: Undifferentiated pleomorphic sarcoma (UPS) and de-differentiated liposarcoma (LPS). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks

17 / 6058 / 602 / 60

Group identifiers: EG000: Soft Tissue Sarcoma · EG001: Bone Sarcoma · EG002: Expansion

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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    Bronchopulmonary hemmorhage
  2. 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
      42
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    Duodenal Perforation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Sepsis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      60
      num Events
      2
    term
    Neoplasms, benign, malignant and unspecified
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Dyspnea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    Hypoxia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    Laryngeal hemmorrhage
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Pleural Effusion
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    Pneumonitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    Nervous system disorders, other
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Acute kidney inury

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
      9
      num At Risk
      42
      num Events
      9
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      42
      num Events
      8
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      60
      num Events
      21
    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
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      60
      num Events
      2
    term
    Blood and Lymphatic Systems Disorder, other
  3. 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
      42
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Febrile Neuropenia
  4. 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
      42
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      60
      num Events
      2
    term
    Leukocytosis
  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
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Cardiac disorders, other
  6. 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
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    palpitations
  7. 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
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Sinus Bradycardia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      60
      num Events
      4
    term
    Sinus Tachycardia
  9. 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
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Ventricular Tachycardia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    Ear and Labyrinth disorders, other
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    Endocrine Disorders-other
  12. 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
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Hyperparathyroidism
Complete source fields
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    42
    description
    Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks Pembrolizumab
    id
    EG000
    other Num Affected
    40
    other Num At Risk
    42
    serious Num Affected
    19
    serious Num At Risk
    42
    title
    Soft Tissue Sarcoma
  2. deaths Num Affected
    2
    deaths Num At Risk
    42
    description
    Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab will be administered at 200 mg intravenously every 3 weeks Pembrolizumab
    id
    EG001
    other Num Affected
    42
    other Num At Risk
    42
    serious Num Affected
    15
    serious Num At Risk
    42
    title
    Bone Sarcoma
  3. deaths Num Affected
    2
    deaths Num At Risk
    60
    description
    Patients with the following types of soft tissue sarcoma: Undifferentiated pleomorphic sarcoma (UPS) and de-differentiated liposarcoma (LPS). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks
    id
    EG002
    other Num Affected
    58
    other Num At Risk
    60
    serious Num Affected
    17
    serious Num At Risk
    60
    title
    Expansion
frequency Threshold
1
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
      9
      num At Risk
      42
      num Events
      9
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      42
      num Events
      8
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      60
      num Events
      21
    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
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      60
      num Events
      2
    term
    Blood and Lymphatic Systems Disorder, other
  3. 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
      42
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Febrile Neuropenia
  4. 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
      42
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      60
      num Events
      2
    term
    Leukocytosis
  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
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Cardiac disorders, other
  6. 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
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    palpitations
  7. 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
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Sinus Bradycardia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      60
      num Events
      4
    term
    Sinus Tachycardia
  9. 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
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Ventricular Tachycardia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    Ear and Labyrinth disorders, other
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    Endocrine Disorders-other
  12. 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
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Hyperparathyroidism
serious Events
  1. assessment Type
    NON_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
      42
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    Bronchopulmonary hemmorhage
  2. 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
      42
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    Duodenal Perforation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Sepsis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      60
      num Events
      2
    term
    Neoplasms, benign, malignant and unspecified
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Dyspnea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    Hypoxia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    Laryngeal hemmorrhage
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Pleural Effusion
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    Pneumonitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    term
    Nervous system disorders, other
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      42
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    term
    Acute kidney inury
time Frame
Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier.

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Preserved source evidence · Not medical advice