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NCT01958021 · ADVERSE EVENTS

Adverse events

Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer · Source last updated 2025-03-07

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 (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 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
Ribociclib + Letrozole

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

108 / 334331 / 3348 / 334
Placebo + Letrozole

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.

62 / 330317 / 3303 / 334
Crossover to Ribociclib + Letrozole

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

1 / 44 / 40 / 4
Ribociclib + Letrozole (Post-treatment Survival 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 / 0178 / 278
Placebo + Letrozole (Post-treatment Survival 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 / 0218 / 298
Crossover to Ribociclib + Fulvestrant (Crossover Post-treatment Survival 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 / 00 / 4

Group identifiers: EG000: Ribociclib + Letrozole · EG001: Placebo + Letrozole · EG002: Crossover to Ribociclib + Letrozole · EG003: Ribociclib + Letrozole (Post-treatment Survival Follow-up) · EG004: Placebo + Letrozole (Post-treatment Survival Follow-up) · EG005: Crossover to Ribociclib + Fulvestrant (Crossover Post-treatment 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
      4
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
    Leukocytosis
  4. 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
      334
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  6. 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
      334
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
    Pancytopenia
  7. 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
      334
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  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
      334
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
    Arrhythmia
  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
      334
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  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
      334
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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 congestive

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
      77
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
    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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
    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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    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
    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
      218
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
    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
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
    Vertigo
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
    Vision blurred
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      99
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      75
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
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
    8
    deaths Num At Risk
    334
    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
    331
    other Num At Risk
    334
    serious Num Affected
    108
    serious Num At Risk
    334
    title
    Ribociclib + Letrozole
  2. deaths Num Affected
    3
    deaths Num At Risk
    334
    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
    317
    other Num At Risk
    330
    serious Num Affected
    62
    serious Num At Risk
    330
    title
    Placebo + Letrozole
  3. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    All-cause mortality and Adverse Events from start of crossover treatment to 30 days post-crossover treatment
    id
    EG002
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Crossover to Ribociclib + Letrozole
  4. deaths Num Affected
    178
    deaths Num At Risk
    278
    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
    Ribociclib + Letrozole (Post-treatment Survival Follow-up)
  5. deaths Num Affected
    218
    deaths Num At Risk
    298
    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
    Placebo + Letrozole (Post-treatment Survival Follow-up)
  6. deaths Num Affected
    0
    deaths Num At Risk
    4
    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
    Crossover to Ribociclib + Fulvestrant (Crossover Post-treatment 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
      77
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
    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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
    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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    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
    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
      218
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
    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
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
    Vertigo
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
    Vision blurred
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      99
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      75
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
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
      4
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
    Leukocytosis
  4. 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
      334
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  6. 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
      334
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
    Pancytopenia
  7. 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
      334
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  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
      334
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
    Arrhythmia
  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
      334
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      334
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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
  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
      334
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      330
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    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 congestive
time Frame
All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months

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Preserved source evidence · Not medical advice