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NCT02196168 · ADVERSE EVENTS

Adverse events

Cisplatin With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer · Source last updated 2017-05-03

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)

Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies WEE1 Inhibitor AZD1775: Given PO

4 / 66 / 6Not reported / Not reported
Arm II (Placebo, Cisplatin)

Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO

0 / 00 / 0Not reported / Not reported

Group identifiers: EG000: Arm I (WEE1 Inhibitor MK-1775, Cisplatin) · EG001: Arm II (Placebo, Cisplatin)

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
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Febrile Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    lymphocyte count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    white blood cell decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    neutrophil count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Generalized Muscle weakness
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Dizziness
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Dehydration
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Lung infection

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Lymphocyte count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Neutrophil count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    white blood cell decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    hypophosphatemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    alkalosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Dehydration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Febrile Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Generalized Muscle weakness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Hyponatremia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Lung infection
Complete source fields
event Groups
  1. description
    Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies WEE1 Inhibitor AZD1775: Given PO
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
  2. description
    Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO
    id
    EG001
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Arm II (Placebo, Cisplatin)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Lymphocyte count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Neutrophil count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    white blood cell decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    hypophosphatemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    alkalosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Dehydration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Febrile Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Generalized Muscle weakness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Hyponatremia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Lung infection
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Febrile Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    lymphocyte count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    white blood cell decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    neutrophil count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Generalized Muscle weakness
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Dizziness
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Dehydration
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Lung infection

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Preserved source evidence · Not medical advice