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NCT01613768 · ADVERSE EVENTS

Adverse events

Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer · Source last updated 2018-09-28

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 events collected from the time patient received the first dose of study therapy through 36 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 36 days post therapy.
Other-event reporting threshold
5%

Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Eribulin Mesylate)

Eribulin mesylate (1.4 mg/m2) administered intravenously (IV) over 2-5 minutes on days 1 and 8 of a 21 day cycle. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

3 / 2916 / 290 / 29

Group identifiers: EG000: Treatment (Eribulin Mesylate)

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Pathological spinal fracture
  3. 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
      29
      num Events
      1
    term
    Epistaxis

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
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      29
      num Events
      4
    term
    Fatigue
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
      num Events
      2
    term
    Malaise
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
      num Events
      2
    term
    Creatinine increased
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      29
      num Events
      14
    term
    Neutrophil count decreased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      29
      num Events
      10
    term
    Peripheral sensory neuropathy
Complete source fields
description
Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    29
    description
    Eribulin mesylate (1.4 mg/m2) administered intravenously (IV) over 2-5 minutes on days 1 and 8 of a 21 day cycle. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    16
    other Num At Risk
    29
    serious Num Affected
    3
    serious Num At Risk
    29
    title
    Treatment (Eribulin Mesylate)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      29
      num Events
      4
    term
    Fatigue
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
      num Events
      2
    term
    Malaise
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
      num Events
      2
    term
    Creatinine increased
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      29
      num Events
      14
    term
    Neutrophil count decreased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      29
      num Events
      10
    term
    Peripheral sensory neuropathy
serious 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
      1
      num At Risk
      29
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      29
      num Events
      1
    term
    Pathological spinal fracture
  3. 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
      29
      num Events
      1
    term
    Epistaxis
time Frame
Adverse events collected from the time patient received the first dose of study therapy through 36 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 36 days post therapy.

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Preserved source evidence · Not medical advice