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NCT01828099 · ADVERSE EVENTS

Adverse events

LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer · Source last updated 2025-01-16

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
All-cause mortality: from randomization up to approx. 120 months, including post-treatment survival follow-up period. Serious and Other Adverse Events (AEs): from first dose of study treatment until 30 days after last dose (or start of crossover treatment), up to approx. 120 months. For participants who crossed over, AEs were also collected from start of crossover treatment to 30 days post-crossover treatment (extension-treatment period), up to approx. 108 months.
Other-event reporting threshold
5%

All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ceritinib

All-cause mortality from randomization until 30 days after last dose. Adverse Events from first dose until 30 days after last dose.

93 / 189186 / 18915 / 189
Chemotherapy

All-cause mortality from randomization until 30 days after last dose or start of crossover treatment. Adverse Events from first dose until 30 days after last dose or start of crossover treatment.

64 / 175166 / 17510 / 187
Chemotherapy to Ceritinib (Extension-treatment)

All-cause mortality and Adverse Events from start of crossover treatment to 30 days post-crossover treatment

47 / 10099 / 10015 / 100
Ceritinib (Post-treatment Follow-up)

Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period

0 / 00 / 098 / 149
Chemotherapy (Post-treatment Follow-up)

Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period

0 / 00 / 038 / 60
Chemotherapy to Ceritinib (Post-treatment Follow-up)

Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose of crossover treatment). No AEs were collected during this period

0 / 00 / 056 / 83

Group identifiers: EG000: Ceritinib · EG001: Chemotherapy · EG002: Chemotherapy to Ceritinib (Extension-treatment) · EG003: Ceritinib (Post-treatment Follow-up) · EG004: Chemotherapy (Post-treatment Follow-up) · EG005: Chemotherapy to Ceritinib (Post-treatment Follow-up)

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 (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Cardiac tamponade
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Cardio-respiratory arrest

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 (26.1)
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Abdominal distension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      160
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      76
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Dyspepsia
Complete source fields
description
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
event Groups
  1. deaths Num Affected
    15
    deaths Num At Risk
    189
    description
    All-cause mortality from randomization until 30 days after last dose. Adverse Events from first dose until 30 days after last dose.
    id
    EG000
    other Num Affected
    186
    other Num At Risk
    189
    serious Num Affected
    93
    serious Num At Risk
    189
    title
    Ceritinib
  2. deaths Num Affected
    10
    deaths Num At Risk
    187
    description
    All-cause mortality from randomization until 30 days after last dose or start of crossover treatment. Adverse Events from first dose until 30 days after last dose or start of crossover treatment.
    id
    EG001
    other Num Affected
    166
    other Num At Risk
    175
    serious Num Affected
    64
    serious Num At Risk
    175
    title
    Chemotherapy
  3. deaths Num Affected
    15
    deaths Num At Risk
    100
    description
    All-cause mortality and Adverse Events from start of crossover treatment to 30 days post-crossover treatment
    id
    EG002
    other Num Affected
    99
    other Num At Risk
    100
    serious Num Affected
    47
    serious Num At Risk
    100
    title
    Chemotherapy to Ceritinib (Extension-treatment)
  4. deaths Num Affected
    98
    deaths Num At Risk
    149
    description
    Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Ceritinib (Post-treatment Follow-up)
  5. deaths Num Affected
    38
    deaths Num At Risk
    60
    description
    Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period
    id
    EG004
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Chemotherapy (Post-treatment Follow-up)
  6. deaths Num Affected
    56
    deaths Num At Risk
    83
    description
    Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose of crossover treatment). No AEs were collected during this period
    id
    EG005
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Chemotherapy to Ceritinib (Post-treatment Follow-up)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Abdominal distension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      160
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      76
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Cardiac tamponade
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      175
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      100
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Cardio-respiratory arrest
time Frame
All-cause mortality: from randomization up to approx. 120 months, including post-treatment survival follow-up period. Serious and Other Adverse Events (AEs): from first dose of study treatment until 30 days after last dose (or start of crossover treatment), up to approx. 120 months. For participants who crossed over, AEs were also collected from start of crossover treatment to 30 days post-crossover treatment (extension-treatment period), up to approx. 108 months.

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Preserved source evidence · Not medical advice