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NCT01996865 · ADVERSE EVENTS

Adverse events

Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma. · Source last updated 2025-07-10

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
Participants were assessed for all-cause mortality from their first dose of study treatment to study completion, (up to approximately 10 years). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period).
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Induction Period: Lenalidomide + Rituximab

Induction Period (12 cycles): participants received lenalidomide 20 mg (10 mg if creatinine clearance ≥ 30 mL/min but \< 60 mL/min) once daily on Days 1 to 21 of every 28-day Cycle for Cycles 1 to 12 AND rituximab 375 mg/m2 every week in Cycle 1 (Days 1, 8, 15, and 22) and Day 1 of every 28-day Cycle for Cycles 3, 5, 7, 9, and 11.

172 / 500491 / 500112 / 500
Arm A: Lenalidomide + Rituximab

Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.

57 / 134129 / 13426 / 134
Arm B: Rituximab

Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29

22 / 132106 / 13232 / 132

Group identifiers: EG000: Induction Period: Lenalidomide + Rituximab · EG001: Arm A: Lenalidomide + Rituximab · EG002: Arm B: Rituximab

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
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      132
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      132
    term
    Basal cell carcinoma
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      132
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Acute coronary syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Angina pectoris
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Aortic valve incompetence

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      77
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      132
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      132
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      132
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      217
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      132
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      132
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      132
    term
    Tinnitus
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      132
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Vision blurred
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      132
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      146
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      132
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      176
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      132
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      132
    term
    Dry mouth
Complete source fields
event Groups
  1. deaths Num Affected
    112
    deaths Num At Risk
    500
    description
    Induction Period (12 cycles): participants received lenalidomide 20 mg (10 mg if creatinine clearance ≥ 30 mL/min but \< 60 mL/min) once daily on Days 1 to 21 of every 28-day Cycle for Cycles 1 to 12 AND rituximab 375 mg/m2 every week in Cycle 1 (Days 1, 8, 15, and 22) and Day 1 of every 28-day Cycle for Cycles 3, 5, 7, 9, and 11.
    id
    EG000
    other Num Affected
    491
    other Num At Risk
    500
    serious Num Affected
    172
    serious Num At Risk
    500
    title
    Induction Period: Lenalidomide + Rituximab
  2. deaths Num Affected
    26
    deaths Num At Risk
    134
    description
    Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
    id
    EG001
    other Num Affected
    129
    other Num At Risk
    134
    serious Num Affected
    57
    serious Num At Risk
    134
    title
    Arm A: Lenalidomide + Rituximab
  3. deaths Num Affected
    32
    deaths Num At Risk
    132
    description
    Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29
    id
    EG002
    other Num Affected
    106
    other Num At Risk
    132
    serious Num Affected
    22
    serious Num At Risk
    132
    title
    Arm B: Rituximab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      77
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      132
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      132
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      132
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      217
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      132
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      132
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      132
    term
    Tinnitus
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      132
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Vision blurred
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      132
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      146
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      132
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      176
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      132
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      132
    term
    Dry mouth
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      132
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      132
    term
    Basal cell carcinoma
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      132
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Acute coronary syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Angina pectoris
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      500
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      134
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      132
    term
    Aortic valve incompetence
time Frame
Participants were assessed for all-cause mortality from their first dose of study treatment to study completion, (up to approximately 10 years). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period).

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