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NCT00974311 · ADVERSE EVENTS

Adverse events

Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy · Source last updated 2018-12-11

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
Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)
Other-event reporting threshold
5%

An event may be categorized as serious in one participant and non serious in another participant, or one participant may experience both serious and non serious event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. All-cause mortality data included all anticipated and unanticipated deaths due to any cause. Safety population included all randomized participants who received at least 1 dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Enzalutamide: DB + OLE Phase

In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal.

319 / 800784 / 800Not reported / Not reported
Placebo: DB Phase

In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months).

155 / 399385 / 399Not reported / Not reported
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase

Participants who received placebo in DB phase, completed DB Phase and entered in optional OLE Phase, received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 7.7 months).

25 / 5047 / 50Not reported / Not reported

Group identifiers: EG000: Enzalutamide: DB + OLE Phase · EG001: Placebo: DB Phase · EG002: Placebo (DB) /Enzalutamide 160 mg (OLE) Phase

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      50
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
    term
    Anaemia of malignant disease
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
    term
    Disseminated intravascular coagulation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
    term
    Pancytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
    term
    Leukocytosis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      50
    term
    Cardiac failure
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
    term
    Angina pectoris
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
    term
    Acute myocardial infarction
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      50
    term
    Cardiac failure congestive
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
    term
    Atrial flutter
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
    term
    Bradycardia

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      123
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      50
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      276
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      166
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      50
    term
    Nausea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      209
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      109
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      50
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      180
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      50
    term
    Diarrhoea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      141
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      84
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      50
    term
    Vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      50
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      280
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      115
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      50
    term
    Fatigue
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      148
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      50
    term
    Asthenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      121
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      50
    term
    Oedema peripheral
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      50
    term
    Pyrexia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      50
    term
    Urinary tract infection
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      108
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      50
    term
    Weight decreased
Complete source fields
description
An event may be categorized as serious in one participant and non serious in another participant, or one participant may experience both serious and non serious event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. All-cause mortality data included all anticipated and unanticipated deaths due to any cause. Safety population included all randomized participants who received at least 1 dose of study drug.
event Groups
  1. description
    In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal.
    id
    EG000
    other Num Affected
    784
    other Num At Risk
    800
    serious Num Affected
    319
    serious Num At Risk
    800
    title
    Enzalutamide: DB + OLE Phase
  2. description
    In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months).
    id
    EG001
    other Num Affected
    385
    other Num At Risk
    399
    serious Num Affected
    155
    serious Num At Risk
    399
    title
    Placebo: DB Phase
  3. description
    Participants who received placebo in DB phase, completed DB Phase and entered in optional OLE Phase, received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 7.7 months).
    id
    EG002
    other Num Affected
    47
    other Num At Risk
    50
    serious Num Affected
    25
    serious Num At Risk
    50
    title
    Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      123
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      50
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      276
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      166
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      50
    term
    Nausea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      209
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      109
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      50
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      180
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      50
    term
    Diarrhoea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      141
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      84
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      50
    term
    Vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      50
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      280
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      115
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      50
    term
    Fatigue
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      148
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      50
    term
    Asthenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      121
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      50
    term
    Oedema peripheral
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      50
    term
    Pyrexia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      50
    term
    Urinary tract infection
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      108
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      50
    term
    Weight decreased
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      50
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
    term
    Anaemia of malignant disease
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
    term
    Disseminated intravascular coagulation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
    term
    Pancytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
    term
    Leukocytosis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      50
    term
    Cardiac failure
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
    term
    Angina pectoris
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
    term
    Acute myocardial infarction
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      50
    term
    Cardiac failure congestive
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
    term
    Atrial flutter
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      800
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      399
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
    term
    Bradycardia
time Frame
Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)

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Preserved source evidence · Not medical advice