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NCT00556374 · ADVERSE EVENTS

Adverse events

Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy · Source last updated 2023-07-27

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
Double-blind (DB) phase: from 1st dose of study drug to 30 days after last dose; Open-label (OL) phase: from 1st dose of OL study drug to 30 days after last dose. Median duration of treatment in DB phase: Placebo 35.4 months and denosumab 35.5 months. Median duration of treatment in OL phase: 37 months
Other-event reporting threshold
5%

All randomized participants who received \>1 dose of treatment; participants were analyzed according to the actual treatment received in double-blind phase. 9 participants randomized to the placebo in the DB phase incorrectly received denosumab. Per protocol, only AEs of special interest and SAEs were collected in the open-label phase. MedDRA 17.1 used in double-blind phase and 24.0 in the open-label phase.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Double-blind Phase: Placebo

Participants received the matching placebo SC Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.

515 / 1690838 / 1690Not reported / Not reported
Double-blind Phase: Denosumab

Participants received 60 mg denosumab SC Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.

521 / 1709882 / 1709Not reported / Not reported
Open-label Phase: Placebo/Denosumab

Participants who received the matching placebo during the double-blind phase, who continued into the open-label phase where they received denosumab 60 mg SC Q6M for up to a maximum of 7 additional doses.

40 / 2450 / 245Not reported / Not reported
Open-label Phase: Denosumab/Denosumab

Participants who received denosumab during the double-blind phase, who continued into the open-label phase where they received denosumab 60 mg SC Q6M for up to a maximum of 7 additional doses.

0 / 10 / 1Not reported / Not reported

Group identifiers: EG000: Double-blind Phase: Placebo · EG001: Double-blind Phase: Denosumab · EG002: Open-label Phase: Placebo/Denosumab · EG003: Open-label Phase: Denosumab/Denosumab

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 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Iron deficiency anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Lymphadenitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Lymphadenopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Acute coronary syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Acute left ventricular failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Angina pectoris
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    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
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      446
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      441
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Arthralgia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      146
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      151
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Back pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      111
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      139
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Bone pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Osteoarthritis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      85
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      107
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Pain in extremity
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Spinal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      86
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Scar pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      234
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      270
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Hot flush
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      94
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      111
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Hypertension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      100
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      109
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Fatigue
Complete source fields
description
All randomized participants who received \>1 dose of treatment; participants were analyzed according to the actual treatment received in double-blind phase. 9 participants randomized to the placebo in the DB phase incorrectly received denosumab. Per protocol, only AEs of special interest and SAEs were collected in the open-label phase. MedDRA 17.1 used in double-blind phase and 24.0 in the open-label phase.
event Groups
  1. description
    Participants received the matching placebo SC Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    id
    EG000
    other Num Affected
    838
    other Num At Risk
    1690
    serious Num Affected
    515
    serious Num At Risk
    1690
    title
    Double-blind Phase: Placebo
  2. description
    Participants received 60 mg denosumab SC Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
    id
    EG001
    other Num Affected
    882
    other Num At Risk
    1709
    serious Num Affected
    521
    serious Num At Risk
    1709
    title
    Double-blind Phase: Denosumab
  3. description
    Participants who received the matching placebo during the double-blind phase, who continued into the open-label phase where they received denosumab 60 mg SC Q6M for up to a maximum of 7 additional doses.
    id
    EG002
    other Num Affected
    0
    other Num At Risk
    245
    serious Num Affected
    40
    serious Num At Risk
    245
    title
    Open-label Phase: Placebo/Denosumab
  4. description
    Participants who received denosumab during the double-blind phase, who continued into the open-label phase where they received denosumab 60 mg SC Q6M for up to a maximum of 7 additional doses.
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Open-label Phase: Denosumab/Denosumab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      446
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      441
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Arthralgia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      146
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      151
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Back pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      111
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      139
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Bone pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Osteoarthritis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      85
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      107
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Pain in extremity
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Spinal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      86
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Scar pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      234
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      270
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Hot flush
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      94
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      111
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Hypertension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      100
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      109
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Fatigue
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Iron deficiency anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Lymphadenitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Lymphadenopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Acute coronary syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Acute left ventricular failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Angina pectoris
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1690
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      245
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    term
    Aortic valve incompetence
time Frame
Double-blind (DB) phase: from 1st dose of study drug to 30 days after last dose; Open-label (OL) phase: from 1st dose of OL study drug to 30 days after last dose. Median duration of treatment in DB phase: Placebo 35.4 months and denosumab 35.5 months. Median duration of treatment in OL phase: 37 months

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Preserved source evidence · Not medical advice