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NCT07217119 · ADVERSE EVENTS

Adverse events

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Feladilimab (GSK3359609) in Participants With RRMM · Source last updated 2026-06-25

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
All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 281 weeks.
Other-event reporting threshold
5%

Safety set included all participants who received at least 1 dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab

Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).

3 / 99 / 97 / 9
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab

Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

6 / 109 / 106 / 10
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab

Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.

1 / 66 / 62 / 6

Group identifiers: EG000: 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab · EG001: 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab · EG002: 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab

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 v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Chest pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pyrexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Rhinovirus infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Craniofacial fracture
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Infusion related reaction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Blood creatinine increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Blood lactic acid increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypercalcaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Osteolysis

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 v28.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      9
      num Events
      4
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      10
      num Events
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Iron deficiency anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      10
      num Events
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      3
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Atrial flutter
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Sinus bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Deafness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypothyroidism
Complete source fields
description
Safety set included all participants who received at least 1 dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
event Groups
  1. deaths Num Affected
    7
    deaths Num At Risk
    9
    description
    Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
    id
    EG000
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    3
    serious Num At Risk
    9
    title
    1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab
  2. deaths Num Affected
    6
    deaths Num At Risk
    10
    description
    Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
    id
    EG001
    other Num Affected
    9
    other Num At Risk
    10
    serious Num Affected
    6
    serious Num At Risk
    10
    title
    2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab
  3. deaths Num Affected
    2
    deaths Num At Risk
    6
    description
    Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      9
      num Events
      4
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      10
      num Events
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Iron deficiency anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      10
      num Events
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      3
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Atrial flutter
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Sinus bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Deafness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypothyroidism
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Chest pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pyrexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Rhinovirus infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Craniofacial fracture
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Infusion related reaction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Blood creatinine increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Blood lactic acid increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypercalcaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Osteolysis
time Frame
All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 281 weeks.

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Preserved source evidence · Not medical advice