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NCT04939142 · ADVERSE EVENTS

Adverse events

A Study of Evaluating the Safety and Efficacy of ATG-010, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) · Source last updated 2026-08-10

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
AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
SVd (Selinexor+Bortezomib+Dexamethasone)

Enrolled patients will be treated with ATG-010( 100 mg/QW, oral ) with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5cycles.

51 / 100100 / 1006 / 100
Vd(Bortezomib+Dexamethasone)

Enrolled patients will be treated with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5 cycles.

24 / 5251 / 522 / 52

Group identifiers: EG000: SVd (Selinexor+Bortezomib+Dexamethasone) · EG001: Vd(Bortezomib+Dexamethasone)

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
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      52
    term
    Infectious pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
    term
    Cataract
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      52
    term
    Decreased platelet count
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      52
    term
    Nervous system disease
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      52
    term
    Respiratory system, thoracic and mediastinal diseases
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      52
    term
    Gastrointestinal system diseases
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      52
    term
    Heart diseases
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
    term
    General disorders and administration site conditions

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 27.0
    stats
    1. group Id
      EG000
      num Affected
      98
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      52
    term
    Blood and lymphatic system disorders
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      52
    term
    Metabolism and nutrition disorders
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      52
    term
    Gastrointestinal system diseases
Complete source fields
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    100
    description
    Enrolled patients will be treated with ATG-010( 100 mg/QW, oral ) with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5cycles.
    id
    EG000
    other Num Affected
    100
    other Num At Risk
    100
    serious Num Affected
    51
    serious Num At Risk
    100
    title
    SVd (Selinexor+Bortezomib+Dexamethasone)
  2. deaths Num Affected
    2
    deaths Num At Risk
    52
    description
    Enrolled patients will be treated with Bortezomib( 1.3 mg/QW, hypodermic injection ) +dexamethasone ( 20 mg/QW, oral ) about 13.5 cycles.
    id
    EG001
    other Num Affected
    51
    other Num At Risk
    52
    serious Num Affected
    24
    serious Num At Risk
    52
    title
    Vd(Bortezomib+Dexamethasone)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      98
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      52
    term
    Blood and lymphatic system disorders
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      90
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      52
    term
    Metabolism and nutrition disorders
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      52
    term
    Gastrointestinal system diseases
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      52
    term
    Infectious pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
    term
    Cataract
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      52
    term
    Decreased platelet count
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      52
    term
    Nervous system disease
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      52
    term
    Respiratory system, thoracic and mediastinal diseases
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      52
    term
    Gastrointestinal system diseases
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      52
    term
    Heart diseases
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      100
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
    term
    General disorders and administration site conditions
time Frame
AEs: from first dose to 30 days post-last dose; SAEs: from consent to 30 days post-last dose. Total collection period: up to 2 years.

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Preserved source evidence · Independent clinical review pending · Not medical advice