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NCT02004028 · ADVERSE EVENTS

Adverse events

Window of Opportunity Study of VS-6063 (Defactinib) in Surgical Resectable Malignant Pleural Mesothelioma Participants · Source last updated 2024-02-20

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
Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1

Defactinib 400 mg BID for 12 days

1 / 107 / 100 / 10
Cohort 2

Defactinib 400 mg BID for 35 days

2 / 108 / 101 / 10
Cohort 3

Defactinib 400 mg BID for 21 days

2 / 106 / 101 / 10
Cohort 4

Defactinib 100 mg BID for 21 days

2 / 52 / 50 / 5

Group identifiers: EG000: Cohort 1 · EG001: Cohort 2 · EG002: Cohort 3 · EG003: Cohort 4

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
    Investigations
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    International Normalised Ratio increased
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Disease progression
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Wound Infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Metastases to central nervous system
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Disseminated intravascular coagulation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Abdominal hernia

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Abdominal distension
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Constipation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Diarrhea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Abdominal pain upper
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Vomiting
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Fatigue
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Pyrexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Hyperbilirubinaemia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Upper Respiratory Infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    International normalised ratio increased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Weight decreased
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    10
    description
    Defactinib 400 mg BID for 12 days
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    10
    serious Num Affected
    1
    serious Num At Risk
    10
    title
    Cohort 1
  2. deaths Num Affected
    1
    deaths Num At Risk
    10
    description
    Defactinib 400 mg BID for 35 days
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    10
    serious Num Affected
    2
    serious Num At Risk
    10
    title
    Cohort 2
  3. deaths Num Affected
    1
    deaths Num At Risk
    10
    description
    Defactinib 400 mg BID for 21 days
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    10
    serious Num Affected
    2
    serious Num At Risk
    10
    title
    Cohort 3
  4. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    Defactinib 100 mg BID for 21 days
    id
    EG003
    other Num Affected
    2
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Cohort 4
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Abdominal distension
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Constipation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Diarrhea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Abdominal pain upper
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Vomiting
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Fatigue
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Pyrexia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Hyperbilirubinaemia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Upper Respiratory Infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    International normalised ratio increased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Weight decreased
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    International Normalised Ratio increased
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Disease progression
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Wound Infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Metastases to central nervous system
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Disseminated intravascular coagulation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Abdominal hernia
time Frame
Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days

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Preserved source evidence · Not medical advice