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NCT04165031 · ADVERSE EVENTS

Adverse events

A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation · Source last updated 2021-11-24

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
Baseline up to 11 months
Other-event reporting threshold
0%

All participants who received at least one dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
LY3499446 Phase 1 Cohort A1 (High Dose)

Participants received high dose LY3499446 as oral monotherapy twice daily (BID) in 21-day cycles.

0 / 22 / 21 / 2
LY3499446 Phase 1 Cohort AO (Mid Dose)

Participant received mid dose LY3499446 as oral monotherapy once every other day (QOD) in 21-day cycles.

0 / 11 / 10 / 1
LY3499446 Phase 1 Cohort A-2 (Low Dose)

Participants received low dose LY3499446 as monotherapy orally once QD in 21-day cycles.

1 / 22 / 21 / 2

Group identifiers: EG000: LY3499446 Phase 1 Cohort A1 (High Dose) · EG001: LY3499446 Phase 1 Cohort AO (Mid Dose) · EG002: LY3499446 Phase 1 Cohort A-2 (Low Dose)

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
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Pyrexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Dyspnoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Hypoxia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Pleural effusion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Respiratory failure

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 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Haemolysis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      2
    term
    Palpitations
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      2
      num Events
      4
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      2
      num Events
      3
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Urinary tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Blood bilirubin increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Haptoglobin decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Decreased appetite
Complete source fields
description
All participants who received at least one dose of study drug.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    2
    description
    Participants received high dose LY3499446 as oral monotherapy twice daily (BID) in 21-day cycles.
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    LY3499446 Phase 1 Cohort A1 (High Dose)
  2. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Participant received mid dose LY3499446 as oral monotherapy once every other day (QOD) in 21-day cycles.
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    LY3499446 Phase 1 Cohort AO (Mid Dose)
  3. deaths Num Affected
    1
    deaths Num At Risk
    2
    description
    Participants received low dose LY3499446 as monotherapy orally once QD in 21-day cycles.
    id
    EG002
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    LY3499446 Phase 1 Cohort A-2 (Low Dose)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Haemolysis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      2
    term
    Palpitations
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      2
      num Events
      4
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      2
      num Events
      3
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Urinary tract infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Blood bilirubin increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Haptoglobin decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Decreased appetite
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Pyrexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Dyspnoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Hypoxia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Pleural effusion
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Respiratory failure
time Frame
Baseline up to 11 months

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