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NCT02422615 · ADVERSE EVENTS

Adverse events

Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. · Source last updated 2023-11-30

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
On-treatment AEs: from 1st dose to 30 days post-treatment (or start of crossover treatment), up to 82 months. Post-treatment efficacy/survival follow-up deaths: from 31 days post-treatment to end of study, up to 82 months. Crossover on-treatment AEs: from 1st dose to 30 days post-crossover treatment, up to 3.5 months. Crossover post-treatment efficacy/survival follow-up deaths: from 31 days post-crossover treatment to end of study, up to 1 year
Other-event reporting threshold
5%

Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment follow-up period are not considered Adverse Events. The total number at risk in the post treatment includes patients that entered the post treatment follow-up period (post-treatment efficacy and/or survival follow-up). Analysis performed in the safety set including participants who received at least one dose of study treatment

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ribociclib + Fulvestrant (On-treatment)

AEs during on-treatment period (up to 30 days after last dose of treatment)

179 / 483475 / 48313 / 483
Ribociclib + Fulvestrant (Post-treatment Efficacy/Survival Follow-up)

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

0 / 00 / 0264 / 380
Placebo + Fulvestrant (On-treatment)

AEs during on-treatment period (up to 30 days after last dose of treatment or one day before first dose of crossover treatment for crossover participants)

51 / 241225 / 2418 / 241
Placebo + Fulvestrant (Post-treatment Efficacy/Survival Follow-up)

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

0 / 00 / 0153 / 210
Crossover to Ribociclib + Fulvestrant (Crossover On-treatment)

AEs during crossover on-treatment period (from start of crossover treatment up to 30 days after last dose of crossover treatment)

1 / 33 / 30 / 3
Crossover to Ribociclib + Fulvestrant (Crossover Post-treatment Efficacy/Survival Follow-up)

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

0 / 00 / 01 / 1

Group identifiers: EG000: Ribociclib + Fulvestrant (On-treatment) · EG001: Ribociclib + Fulvestrant (Post-treatment Efficacy/Survival Follow-up) · EG002: Placebo + Fulvestrant (On-treatment) · EG003: Placebo + Fulvestrant (Post-treatment Efficacy/Survival Follow-up) · EG004: Crossover to Ribociclib + Fulvestrant (Crossover On-treatment) · EG005: Crossover to Ribociclib + Fulvestrant (Crossover Post-treatment Efficacy/Survival 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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Immune thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Acute coronary syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Angina pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Aortic valve sclerosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Atrioventricular block second degree

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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      92
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
    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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      279
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Vertigo
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Lacrimation increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      123
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Constipation
Complete source fields
description
Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment follow-up period are not considered Adverse Events. The total number at risk in the post treatment includes patients that entered the post treatment follow-up period (post-treatment efficacy and/or survival follow-up). Analysis performed in the safety set including participants who received at least one dose of study treatment
event Groups
  1. deaths Num Affected
    13
    deaths Num At Risk
    483
    description
    AEs during on-treatment period (up to 30 days after last dose of treatment)
    id
    EG000
    other Num Affected
    475
    other Num At Risk
    483
    serious Num Affected
    179
    serious Num At Risk
    483
    title
    Ribociclib + Fulvestrant (On-treatment)
  2. deaths Num Affected
    264
    deaths Num At Risk
    380
    description
    Deaths collected in the post- treatment efficacy/survival follow-up period (starting from day 31 post- treatment). No AEs were collected during this period
    id
    EG001
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Ribociclib + Fulvestrant (Post-treatment Efficacy/Survival Follow-up)
  3. deaths Num Affected
    8
    deaths Num At Risk
    241
    description
    AEs during on-treatment period (up to 30 days after last dose of treatment or one day before first dose of crossover treatment for crossover participants)
    id
    EG002
    other Num Affected
    225
    other Num At Risk
    241
    serious Num Affected
    51
    serious Num At Risk
    241
    title
    Placebo + Fulvestrant (On-treatment)
  4. deaths Num Affected
    153
    deaths Num At Risk
    210
    description
    Deaths collected in the post- treatment efficacy/survival follow-up period (starting from day 31 post- treatment). 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
    Placebo + Fulvestrant (Post-treatment Efficacy/Survival Follow-up)
  5. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    AEs during crossover on-treatment period (from start of crossover treatment up to 30 days after last dose of crossover treatment)
    id
    EG004
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Crossover to Ribociclib + Fulvestrant (Crossover On-treatment)
  6. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Deaths collected in the crossover post-treatment efficacy/survival follow-up period (starting from day 31 post-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
    Crossover to Ribociclib + Fulvestrant (Crossover Post-treatment Efficacy/Survival Follow-up)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      92
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
    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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      279
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Vertigo
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Lacrimation increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      123
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Immune thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Acute coronary syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Angina pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Aortic valve sclerosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      483
    2. group Id
      EG001
      num At Risk
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      241
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num At Risk
      0
    term
    Atrioventricular block second degree
time Frame
On-treatment AEs: from 1st dose to 30 days post-treatment (or start of crossover treatment), up to 82 months. Post-treatment efficacy/survival follow-up deaths: from 31 days post-treatment to end of study, up to 82 months. Crossover on-treatment AEs: from 1st dose to 30 days post-crossover treatment, up to 3.5 months. Crossover post-treatment efficacy/survival follow-up deaths: from 31 days post-crossover treatment to end of study, up to 1 year

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Preserved source evidence · Not medical advice