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NCT03505710 · ADVERSE EVENTS

Adverse events

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer · Source last updated 2025-05-30

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
Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months.
Other-event reporting threshold
5%

A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1: HER2 Overexpressing

Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.

28 / 4946 / 4942 / 49
Cohort 1a: HER2 Overexpressing

Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.

18 / 4141 / 4132 / 41
Cohort 2: HER2 Mutated

Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.

40 / 9191 / 9172 / 91

Group identifiers: EG000: Cohort 1: HER2 Overexpressing · EG001: Cohort 1a: HER2 Overexpressing · EG002: Cohort 2: HER2 Mutated

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
    General disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      91
    term
    Disease Progression
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      91
    term
    Pneumonitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      91
    term
    Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      91
    term
    Dyspnoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      91
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      91
    term
    Seizure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      91
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      91
    term
    Hypoxia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      91
    term
    Interstitial Lung Disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      91
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      91
    term
    Pleural Effusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      91
    term
    Central Nervous System Necrosis

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      69
      num At Risk
      91
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      91
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      42
      num At Risk
      91
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      91
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      91
    term
    Abdominal Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      91
    term
    Stomatitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      91
    term
    Gastrooesophageal Reflux Disease
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      91
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      91
    term
    Dysphagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      91
    term
    Abdominal Pain Upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      91
    term
    Haemorrhoids
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      91
    term
    Haemorrhoidal Haemorrhage
Complete source fields
description
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
event Groups
  1. deaths Num Affected
    42
    deaths Num At Risk
    49
    description
    Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
    id
    EG000
    other Num Affected
    46
    other Num At Risk
    49
    serious Num Affected
    28
    serious Num At Risk
    49
    title
    Cohort 1: HER2 Overexpressing
  2. deaths Num Affected
    32
    deaths Num At Risk
    41
    description
    Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
    id
    EG001
    other Num Affected
    41
    other Num At Risk
    41
    serious Num Affected
    18
    serious Num At Risk
    41
    title
    Cohort 1a: HER2 Overexpressing
  3. deaths Num Affected
    72
    deaths Num At Risk
    91
    description
    Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
    id
    EG002
    other Num Affected
    91
    other Num At Risk
    91
    serious Num Affected
    40
    serious Num At Risk
    91
    title
    Cohort 2: HER2 Mutated
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      69
      num At Risk
      91
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      91
    term
    Diarrhoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      42
      num At Risk
      91
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      91
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      91
    term
    Abdominal Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      91
    term
    Stomatitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      91
    term
    Gastrooesophageal Reflux Disease
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      91
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      91
    term
    Dysphagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      91
    term
    Abdominal Pain Upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      91
    term
    Haemorrhoids
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      91
    term
    Haemorrhoidal Haemorrhage
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      91
    term
    Disease Progression
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      91
    term
    Pneumonitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      91
    term
    Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      91
    term
    Dyspnoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      91
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      91
    term
    Seizure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      91
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      91
    term
    Hypoxia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      91
    term
    Interstitial Lung Disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      91
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      91
    term
    Pleural Effusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (23.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      41
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      91
    term
    Central Nervous System Necrosis
time Frame
Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

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