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NCT01907100 · ADVERSE EVENTS

Adverse events

Nintedanib (BIBF 1120) in Mesothelioma · Source last updated 2019-03-18

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
SAE & Non SAE: From first dose until 28 days (Phase II) or 30 days (Phase III) after last dose, up to approximately (approx.) 30 months in Phase II and approx. 32 months in Phase III. All-cause mortality: From randomization until end of follow-up, up to approx. 30 months in Phase II and approx. 32 months in Phase III
Other-event reporting threshold
5%

All-cause mortality numbers are based on randomized set whereas Serious Adverse Events (SAE) and non-SAE are based on treated set.

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

Phase II part: Nintedanib matching placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.

17 / 4141 / 4125 / 43
Nintedanib_Phase II

Phase II part: Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.

16 / 4444 / 4422 / 44
Placebo_Phase III

Phase III part: Nintedanib matching Placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.

89 / 228219 / 22863 / 229
Nintedanib_Phase III

Phase III part: Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.

99 / 227218 / 22764 / 229

Group identifiers: EG000: Placebo_Phase II · EG001: Nintedanib_Phase II · EG002: Placebo_Phase III · EG003: Nintedanib_Phase III

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 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      227
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      227
    term
    Febrile bone marrow aplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      227
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      227
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      227
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      227
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      227
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      227
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      227
    term
    Deafness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      227
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      227
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      227
    term
    Dysphagia

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 20.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      94
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      76
      num At Risk
      227
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      227
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      82
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      83
      num At Risk
      227
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      227
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      227
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      227
    term
    Dry eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      227
    term
    Lacrimation increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      24
      num At Risk
      227
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      227
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      73
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      60
      num At Risk
      227
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      118
      num At Risk
      227
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      227
    term
    Dyspepsia
Complete source fields
description
All-cause mortality numbers are based on randomized set whereas Serious Adverse Events (SAE) and non-SAE are based on treated set.
event Groups
  1. deaths Num Affected
    25
    deaths Num At Risk
    43
    description
    Phase II part: Nintedanib matching placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
    id
    EG000
    other Num Affected
    41
    other Num At Risk
    41
    serious Num Affected
    17
    serious Num At Risk
    41
    title
    Placebo_Phase II
  2. deaths Num Affected
    22
    deaths Num At Risk
    44
    description
    Phase II part: Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
    id
    EG001
    other Num Affected
    44
    other Num At Risk
    44
    serious Num Affected
    16
    serious Num At Risk
    44
    title
    Nintedanib_Phase II
  3. deaths Num Affected
    63
    deaths Num At Risk
    229
    description
    Phase III part: Nintedanib matching Placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
    id
    EG002
    other Num Affected
    219
    other Num At Risk
    228
    serious Num Affected
    89
    serious Num At Risk
    228
    title
    Placebo_Phase III
  4. deaths Num Affected
    64
    deaths Num At Risk
    229
    description
    Phase III part: Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
    id
    EG003
    other Num Affected
    218
    other Num At Risk
    227
    serious Num Affected
    99
    serious Num At Risk
    227
    title
    Nintedanib_Phase III
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      94
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      76
      num At Risk
      227
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      227
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      82
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      83
      num At Risk
      227
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      227
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      227
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      227
    term
    Dry eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      227
    term
    Lacrimation increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      24
      num At Risk
      227
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      227
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      73
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      60
      num At Risk
      227
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      118
      num At Risk
      227
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      227
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      227
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      227
    term
    Febrile bone marrow aplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      227
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      227
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      227
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      227
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      227
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      227
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      227
    term
    Deafness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      227
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      227
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      44
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      228
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      227
    term
    Dysphagia
time Frame
SAE & Non SAE: From first dose until 28 days (Phase II) or 30 days (Phase III) after last dose, up to approximately (approx.) 30 months in Phase II and approx. 32 months in Phase III. All-cause mortality: From randomization until end of follow-up, up to approx. 30 months in Phase II and approx. 32 months in Phase III

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Preserved source evidence · Not medical advice