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NCT01283516 · ADVERSE EVENTS

Adverse events

A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase · Source last updated 2019-03-15

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 (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), at least 30 days following the last dose of study treatment . All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
LDK378 50 mg

Participants receiving 50 mg of LDK378

0 / 22 / 2Not reported / Not reported
LDK378 100 mg

Participants receiving 100 mg of LDK378

1 / 22 / 2Not reported / Not reported
LDK378 200 mg

Participants receiving 200 mg of LDK378

1 / 33 / 3Not reported / Not reported
LDK378 300 mg

Participants receiving 300 mg of LDK378

1 / 33 / 3Not reported / Not reported
LDK378 400 mg

Participants receiving 400 mg of LDK378

7 / 1414 / 14Not reported / Not reported
LDK378 500 mg

Participants receiving 500 mg of LDK378

4 / 1010 / 10Not reported / Not reported
LDK378 600 mg

Participants receiving 600 mg of LDK378

7 / 1010 / 10Not reported / Not reported
LDK378 700 mg

Participants receiving 700 mg of LDK378

3 / 55 / 5Not reported / Not reported
LDK378 750 mg

Participants receiving 750 mg of LDK378.

145 / 255254 / 255Not reported / Not reported
All Participants

All participants enrolled in the study

169 / 304303 / 304Not reported / Not reported

Group identifiers: EG000: LDK378 50 mg · EG001: LDK378 100 mg · EG002: LDK378 200 mg · EG003: LDK378 300 mg · EG004: LDK378 400 mg · EG005: LDK378 500 mg · EG006: LDK378 600 mg · EG007: LDK378 700 mg · EG008: LDK378 750 mg · EG009: All Participants

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 (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      304
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      304
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      304
    term
    Acute Myocardial Infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      304
    term
    Angina Pectoris
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      304
    term
    Atrial Fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      304
    term
    Cardiac Failure Congestive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      304
    term
    Cardiac Tamponade
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      304
    term
    Cardio-Respiratory Arrest
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      6
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      7
      num At Risk
      304
    term
    Pericardial Effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      5
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      5
      num At Risk
      304
    term
    Pericarditis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      304
    term
    Stress Cardiomyopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      304
    term
    Supraventricular Extrasystoles

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 (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      32
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      40
      num At Risk
      304
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      304
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      304
    term
    Arrhythmia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      304
    term
    Atrial Fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      5
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      6
      num At Risk
      304
    term
    Bradycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      5
      num At Risk
      304
    term
    Sinus Bradycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      304
    term
    Sinus Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      6
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      7
      num At Risk
      304
    term
    Tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      7
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      8
      num At Risk
      304
    term
    Tinnitus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      7
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      8
      num At Risk
      304
    term
    Vertigo
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      5
      num At Risk
      304
    term
    Blepharospasm
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      304
    term
    Diplopia
Complete source fields
event Groups
  1. description
    Participants receiving 50 mg of LDK378
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    LDK378 50 mg
  2. description
    Participants receiving 100 mg of LDK378
    id
    EG001
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    LDK378 100 mg
  3. description
    Participants receiving 200 mg of LDK378
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    LDK378 200 mg
  4. description
    Participants receiving 300 mg of LDK378
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    LDK378 300 mg
  5. description
    Participants receiving 400 mg of LDK378
    id
    EG004
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    7
    serious Num At Risk
    14
    title
    LDK378 400 mg
  6. description
    Participants receiving 500 mg of LDK378
    id
    EG005
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    4
    serious Num At Risk
    10
    title
    LDK378 500 mg
  7. description
    Participants receiving 600 mg of LDK378
    id
    EG006
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    7
    serious Num At Risk
    10
    title
    LDK378 600 mg
  8. description
    Participants receiving 700 mg of LDK378
    id
    EG007
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    LDK378 700 mg
  9. description
    Participants receiving 750 mg of LDK378.
    id
    EG008
    other Num Affected
    254
    other Num At Risk
    255
    serious Num Affected
    145
    serious Num At Risk
    255
    title
    LDK378 750 mg
  10. description
    All participants enrolled in the study
    id
    EG009
    other Num Affected
    303
    other Num At Risk
    304
    serious Num Affected
    169
    serious Num At Risk
    304
    title
    All Participants
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      32
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      40
      num At Risk
      304
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      304
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      304
    term
    Arrhythmia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      304
    term
    Atrial Fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      5
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      6
      num At Risk
      304
    term
    Bradycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      5
      num At Risk
      304
    term
    Sinus Bradycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      304
    term
    Sinus Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      6
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      7
      num At Risk
      304
    term
    Tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      7
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      8
      num At Risk
      304
    term
    Tinnitus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      7
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      8
      num At Risk
      304
    term
    Vertigo
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      4
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      5
      num At Risk
      304
    term
    Blepharospasm
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      304
    term
    Diplopia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      304
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      304
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      304
    term
    Acute Myocardial Infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      304
    term
    Angina Pectoris
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      304
    term
    Atrial Fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      304
    term
    Cardiac Failure Congestive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      304
    term
    Cardiac Tamponade
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      304
    term
    Cardio-Respiratory Arrest
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      6
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      7
      num At Risk
      304
    term
    Pericardial Effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      5
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      5
      num At Risk
      304
    term
    Pericarditis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      304
    term
    Stress Cardiomyopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      14
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      10
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      255
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      304
    term
    Supraventricular Extrasystoles
time Frame
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), at least 30 days following the last dose of study treatment . All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice