Skip to content
Triangle logo TriangleGet started
← Full study record

NCT05023980 · ADVERSE EVENTS

Adverse events

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) · Source last updated 2026-09-25

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
From randomization up to 41 months
Other-event reporting threshold
5%

* All participants who were randomized and received at least one dose (including a partial dose) of study treatment were prespecified to be monitored and assessed for serious and other (not including serious) adverse events, and all randomized participants were monitored for All-Cause Mortality, accordingly the data has been reported. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A - Pirtobrutinib

Participants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.

43 / 140109 / 1403 / 141
Arm B - Bendamustine Plus Rituximab

Participants received bendamustine 90 milligrams per square meter (mg/m²) intravenously on Days 1 and 2 of each 28-day cycle (Cycles 1-6) plus rituximab 375 mg/m² intravenously on Cycle 1 Day 1, then 500 mg/m² on Day 1 of Cycles 2-6. Eligible participants in Arm B crossed over to receive pirtobrutinib following independent review committee (IRC)-confirmed progressive disease (PD).

41 / 132111 / 13210 / 141
Arm B - Crossover to Pirtobrutinib

Participants initially assigned to Arm B who met crossover eligibility criteria following IRC-confirmed PD received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.

1 / 1811 / 180 / 18

Group identifiers: EG000: Arm A - Pirtobrutinib · EG001: Arm B - Bendamustine Plus Rituximab · EG002: Arm B - Crossover to Pirtobrutinib

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 28.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      140
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      132
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
      num Events
      2
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      132
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Haemolytic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Myelosuppression
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Atrioventricular block second degree
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Cardio-respiratory arrest
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Myocardial ischaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Chronic gastritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Duodenal ulcer
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Non-cardiac chest pain

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 28.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      140
      num Events
      18
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      132
      num Events
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      2
    term
    Iron deficiency anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      132
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      132
      num Events
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      140
      num Events
      26
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      132
      num Events
      122
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      140
      num Events
      12
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      132
      num Events
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Palpitations
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      140
      num Events
      7
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      132
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      140
      num Events
      12
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      132
      num Events
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      140
      num Events
      3
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      132
      num Events
      52
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      140
      num Events
      12
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      132
      num Events
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Vomiting
Complete source fields
description
* All participants who were randomized and received at least one dose (including a partial dose) of study treatment were prespecified to be monitored and assessed for serious and other (not including serious) adverse events, and all randomized participants were monitored for All-Cause Mortality, accordingly the data has been reported. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    141
    description
    Participants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    109
    other Num At Risk
    140
    serious Num Affected
    43
    serious Num At Risk
    140
    title
    Arm A - Pirtobrutinib
  2. deaths Num Affected
    10
    deaths Num At Risk
    141
    description
    Participants received bendamustine 90 milligrams per square meter (mg/m²) intravenously on Days 1 and 2 of each 28-day cycle (Cycles 1-6) plus rituximab 375 mg/m² intravenously on Cycle 1 Day 1, then 500 mg/m² on Day 1 of Cycles 2-6. Eligible participants in Arm B crossed over to receive pirtobrutinib following independent review committee (IRC)-confirmed progressive disease (PD).
    id
    EG001
    other Num Affected
    111
    other Num At Risk
    132
    serious Num Affected
    41
    serious Num At Risk
    132
    title
    Arm B - Bendamustine Plus Rituximab
  3. deaths Num Affected
    0
    deaths Num At Risk
    18
    description
    Participants initially assigned to Arm B who met crossover eligibility criteria following IRC-confirmed PD received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.
    id
    EG002
    other Num Affected
    11
    other Num At Risk
    18
    serious Num Affected
    1
    serious Num At Risk
    18
    title
    Arm B - Crossover to Pirtobrutinib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      140
      num Events
      18
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      132
      num Events
      25
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      2
    term
    Iron deficiency anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      132
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      132
      num Events
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      140
      num Events
      26
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      132
      num Events
      122
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      140
      num Events
      12
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      132
      num Events
      29
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Palpitations
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      140
      num Events
      7
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      132
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      140
      num Events
      12
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      132
      num Events
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      140
      num Events
      3
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      132
      num Events
      52
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      140
      num Events
      12
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      132
      num Events
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      140
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      132
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
      num Events
      2
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      132
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Haemolytic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Myelosuppression
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Atrioventricular block second degree
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Cardio-respiratory arrest
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Myocardial ischaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Chronic gastritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Duodenal ulcer
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Non-cardiac chest pain
time Frame
From randomization up to 41 months

Download exact source JSON → · Snapshot ctgov-results-aad7e863b8b06225cd4e94e7

Preserved source evidence · Not medical advice