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NCT01327053 · ADVERSE EVENTS

Adverse events

A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma · Source last updated 2019-08-28

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 and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 76.2 months.
Other-event reporting threshold
5%

All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of approx. 7 years.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
LDE225 200 mg qd

Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.

16 / 7976 / 791 / 79
LDE225 800 mg qd

Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.

58 / 150145 / 1507 / 150

Group identifiers: EG000: LDE225 200 mg qd · EG001: LDE225 800 mg qd

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
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      150
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Angina pectoris
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Bundle branch block left
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Cardiac failure congestive
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Cardiovascular insufficiency
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Chronic gastritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      150
    term
    Diarrhoea

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
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      150
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      150
    term
    Vertigo
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      150
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      150
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      150
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      150
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      150
    term
    Dry mouth
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      150
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      150
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      150
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      150
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      150
    term
    Pyrexia
Complete source fields
description
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of approx. 7 years.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    79
    description
    Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
    id
    EG000
    other Num Affected
    76
    other Num At Risk
    79
    serious Num Affected
    16
    serious Num At Risk
    79
    title
    LDE225 200 mg qd
  2. deaths Num Affected
    7
    deaths Num At Risk
    150
    description
    Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
    id
    EG001
    other Num Affected
    145
    other Num At Risk
    150
    serious Num Affected
    58
    serious Num At Risk
    150
    title
    LDE225 800 mg qd
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      150
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      150
    term
    Vertigo
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      150
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      150
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      150
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      150
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      150
    term
    Dry mouth
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      150
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      150
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      150
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      150
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      150
    term
    Pyrexia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      150
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Angina pectoris
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Bradycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Bundle branch block left
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Cardiac failure congestive
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Cardiovascular insufficiency
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Chronic gastritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      150
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      79
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      150
    term
    Diarrhoea
time Frame
Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 76.2 months.

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