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NCT00747123 · ADVERSE EVENTS

Adverse events

A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma · Source last updated 2024-10-03

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 randomization to study completion, (up to approximately 10 months). SAEs and Other AEs were assessed from first dose to Day 169.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
ACE 011 0.1 mg/kg

0.1 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169).

1 / 87 / 81 / 8
ACE 011 0.3 mg/kg

0.3 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169)

0 / 87 / 80 / 8
ACE 011 0.5 mg/kg

0.5 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169).

3 / 88 / 80 / 8
Placebo

Placebo was administered within 28 days of screening. Subsequent doses were administered every 28 days for a total of four doses.

0 / 64 / 60 / 6

Group identifiers: EG000: ACE 011 0.1 mg/kg · EG001: ACE 011 0.3 mg/kg · EG002: ACE 011 0.5 mg/kg · EG003: Placebo

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
    Cardiac disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Atrial fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Sudden death
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Pain in extremity
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Pathological fracture

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
    11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    term
    Eosinophilia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Granulocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      6
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Atrial conduction time prolongation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    term
    Myocardial ischaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    term
    Sinus bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Hypothyroidism
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    8
    description
    0.1 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169).
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    1
    serious Num At Risk
    8
    title
    ACE 011 0.1 mg/kg
  2. deaths Num Affected
    0
    deaths Num At Risk
    8
    description
    0.3 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169)
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    0
    serious Num At Risk
    8
    title
    ACE 011 0.3 mg/kg
  3. deaths Num Affected
    0
    deaths Num At Risk
    8
    description
    0.5 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169).
    id
    EG002
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    3
    serious Num At Risk
    8
    title
    ACE 011 0.5 mg/kg
  4. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Placebo was administered within 28 days of screening. Subsequent doses were administered every 28 days for a total of four doses.
    id
    EG003
    other Num Affected
    4
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    term
    Eosinophilia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Granulocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      6
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Atrial conduction time prolongation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    term
    Myocardial ischaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    term
    Sinus bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Hypothyroidism
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Atrial fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Sudden death
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Pain in extremity
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    11.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Pathological fracture
time Frame
Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 10 months). SAEs and Other AEs were assessed from first dose to Day 169.

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