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NCT01345019 · ADVERSE EVENTS

Adverse events

Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma · Source last updated 2022-11-08

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
DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
DB: Zoledronic Acid

Participants received zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks (Q4W) in the double-blind (DB) treatment phase.

447 / 852778 / 852Not reported / Not reported
DB: Denosumab

Participants received denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind (DB) treatment phase.

434 / 850757 / 850Not reported / Not reported
OL: Zoledronic Acid / Denosumab

Participants who received zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously (SC) once every 4 weeks (Q4W) in the double-blind treatment phase received denosumab 120 mg SC Q4W in the open-label (OL) treatment phase.

159 / 418313 / 418Not reported / Not reported
OL: Denosumab / Denosumab

Participants who received denosumab 120 mg subcutaneously (SC) plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind treatment phase received denosumab 120 mg SC Q4W in the open-label (OL) treatment phase.

156 / 426312 / 426Not reported / Not reported

Group identifiers: EG000: DB: Zoledronic Acid · EG001: DB: Denosumab · EG002: OL: Zoledronic Acid / Denosumab · EG003: OL: 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 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      426
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      426
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      426
    term
    Autoimmune haemolytic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      426
    term
    Bicytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      426
    term
    Bone marrow failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      426
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      426
    term
    Haemolytic anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      426
    term
    Hyperviscosity syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      426
    term
    Leukocytosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      426
    term
    Leukopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      426
    term
    Neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      426
    term
    Pancytopenia

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 22.0
    stats
    1. group Id
      EG000
      num Affected
      185
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      208
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      51
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      62
      num At Risk
      426
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      426
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      166
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      173
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      40
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      51
      num At Risk
      426
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      151
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      174
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      27
      num At Risk
      426
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      426
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      214
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      207
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      27
      num At Risk
      426
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      301
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      304
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      73
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      57
      num At Risk
      426
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      426
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      274
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      284
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      35
      num At Risk
      426
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      426
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      159
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      147
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      426
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      128
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      112
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      426
    term
    Asthenia
Complete source fields
event Groups
  1. description
    Participants received zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks (Q4W) in the double-blind (DB) treatment phase.
    id
    EG000
    other Num Affected
    778
    other Num At Risk
    852
    serious Num Affected
    447
    serious Num At Risk
    852
    title
    DB: Zoledronic Acid
  2. description
    Participants received denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind (DB) treatment phase.
    id
    EG001
    other Num Affected
    757
    other Num At Risk
    850
    serious Num Affected
    434
    serious Num At Risk
    850
    title
    DB: Denosumab
  3. description
    Participants who received zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously (SC) once every 4 weeks (Q4W) in the double-blind treatment phase received denosumab 120 mg SC Q4W in the open-label (OL) treatment phase.
    id
    EG002
    other Num Affected
    313
    other Num At Risk
    418
    serious Num Affected
    159
    serious Num At Risk
    418
    title
    OL: Zoledronic Acid / Denosumab
  4. description
    Participants who received denosumab 120 mg subcutaneously (SC) plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind treatment phase received denosumab 120 mg SC Q4W in the open-label (OL) treatment phase.
    id
    EG003
    other Num Affected
    312
    other Num At Risk
    426
    serious Num Affected
    156
    serious Num At Risk
    426
    title
    OL: Denosumab / Denosumab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      185
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      208
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      51
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      62
      num At Risk
      426
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      426
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      166
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      173
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      40
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      51
      num At Risk
      426
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      151
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      174
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      27
      num At Risk
      426
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      426
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      214
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      207
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      27
      num At Risk
      426
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      301
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      304
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      73
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      57
      num At Risk
      426
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      426
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      274
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      284
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      35
      num At Risk
      426
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      426
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      159
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      147
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      426
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      128
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      112
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      426
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      426
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      426
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      426
    term
    Autoimmune haemolytic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      426
    term
    Bicytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      426
    term
    Bone marrow failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      426
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      426
    term
    Haemolytic anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      426
    term
    Hyperviscosity syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      426
    term
    Leukocytosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      426
    term
    Leukopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      426
    term
    Neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      852
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      850
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      418
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      426
    term
    Pancytopenia
time Frame
DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.

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