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NCT02499770 · ADVERSE EVENTS

Adverse events

Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC) · Source last updated 2020-08-21

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 AEs occurring from the first date of administration of trilaciclib or placebo + E/P therapy through and including 30 calendar days after the last administration of trilaciclib or placebo + E/P therapy were recorded (a minimum of 51 days up to a maximum of 374 days).
Other-event reporting threshold
5%

AEs are reported for the safety analysis set which included all enrolled participants (i.e., signed informed consent) who received at least 1 dose of study drug (etoposide, carboplatin, or trilaciclib). Analyses using the safety analysis set were conducted on the basis of the actual treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1: Cohort 1 Trilaciclib 200 mg/m^2

Participants received trilaciclib 200 mg/m\^2 administered intravenously (IV) once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle. One participant was screened and dosed at trilaciclib 200 mg/m\^2 for Part 2 of the study without being randomized. AEs for this participant are summarized under the Part 1 trilaciclib 200 mg/m\^2 cohort for the safety analysis set. One participant was enrolled in the Part 1 trilaciclib 240 mg/m\^2 cohort, but dosed at trilaciclib 200 mg/m\^2. AEs for this participant's are presented in the trilaciclib 200 mg/m\^2 cohort for the safety analysis set.

4 / 1212 / 129 / 12
Part 1: Cohort 2 Trilaciclib 240mg/m^2

Participants received trilaciclib 240 mg/m\^2 administered IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.

1 / 88 / 88 / 8
Part 2: Placebo

Participants received placebo IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.

9 / 3736 / 3728 / 37
Part 2: Trilaciclib 240 mg/m^2

Participants received trilaciclib 240 mg/m\^2 IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.

11 / 3837 / 3828 / 38

Group identifiers: EG000: Part 1: Cohort 1 Trilaciclib 200 mg/m^2 · EG001: Part 1: Cohort 2 Trilaciclib 240mg/m^2 · EG002: Part 2: Placebo · EG003: Part 2: Trilaciclib 240 mg/m^2

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Deep vein thrombosis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Cardiac failure chronic
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Acute myocardial infarction
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Myocardial infarction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Sinus tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
      num Events
      1
    term
    Febrile neutropenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      37
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Anemia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Anemia macrocytic
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Neutropenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
      num Events
      2
    term
    Respiratory failure
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
      num Events
      1
    term
    Hemoptysis

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      38
      num Events
      4
    term
    Infusion related reaction
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      8
      num Events
      3
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      37
      num Events
      32
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      38
      num Events
      9
    term
    Neutrophil count decreased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
      num Events
      3
    term
    Blood creatinine increased
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      37
      num Events
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      38
      num Events
      11
    term
    Platelet count decreased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      37
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
      num Events
      2
    term
    Weight decreased
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      8
      num Events
      4
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      37
      num Events
      5
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      38
      num Events
      11
    term
    Dyspnea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      37
      num Events
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      38
      num Events
      8
    term
    Cough
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      38
      num Events
      3
    term
    Oropharyngeal pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      30
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      8
      num Events
      14
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      37
      num Events
      76
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      38
      num Events
      17
    term
    Neutropenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      8
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      37
      num Events
      35
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      38
      num Events
      12
    term
    Thrombocytopenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      21
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      3
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      37
      num Events
      45
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      38
      num Events
      19
    term
    Anemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      37
      num Events
      13
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
      num Events
      2
    term
    Leukopenia
Complete source fields
description
AEs are reported for the safety analysis set which included all enrolled participants (i.e., signed informed consent) who received at least 1 dose of study drug (etoposide, carboplatin, or trilaciclib). Analyses using the safety analysis set were conducted on the basis of the actual treatment.
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    12
    description
    Participants received trilaciclib 200 mg/m\^2 administered intravenously (IV) once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle. One participant was screened and dosed at trilaciclib 200 mg/m\^2 for Part 2 of the study without being randomized. AEs for this participant are summarized under the Part 1 trilaciclib 200 mg/m\^2 cohort for the safety analysis set. One participant was enrolled in the Part 1 trilaciclib 240 mg/m\^2 cohort, but dosed at trilaciclib 200 mg/m\^2. AEs for this participant's are presented in the trilaciclib 200 mg/m\^2 cohort for the safety analysis set.
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    4
    serious Num At Risk
    12
    title
    Part 1: Cohort 1 Trilaciclib 200 mg/m^2
  2. deaths Num Affected
    8
    deaths Num At Risk
    8
    description
    Participants received trilaciclib 240 mg/m\^2 administered IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    1
    serious Num At Risk
    8
    title
    Part 1: Cohort 2 Trilaciclib 240mg/m^2
  3. deaths Num Affected
    28
    deaths Num At Risk
    37
    description
    Participants received placebo IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
    id
    EG002
    other Num Affected
    36
    other Num At Risk
    37
    serious Num Affected
    9
    serious Num At Risk
    37
    title
    Part 2: Placebo
  4. deaths Num Affected
    28
    deaths Num At Risk
    38
    description
    Participants received trilaciclib 240 mg/m\^2 IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
    id
    EG003
    other Num Affected
    37
    other Num At Risk
    38
    serious Num Affected
    11
    serious Num At Risk
    38
    title
    Part 2: Trilaciclib 240 mg/m^2
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      38
      num Events
      4
    term
    Infusion related reaction
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      8
      num Events
      3
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      37
      num Events
      32
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      38
      num Events
      9
    term
    Neutrophil count decreased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
      num Events
      3
    term
    Blood creatinine increased
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      37
      num Events
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      38
      num Events
      11
    term
    Platelet count decreased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      37
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
      num Events
      2
    term
    Weight decreased
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      8
      num Events
      4
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      37
      num Events
      5
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      38
      num Events
      11
    term
    Dyspnea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      37
      num Events
      5
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      38
      num Events
      8
    term
    Cough
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      38
      num Events
      3
    term
    Oropharyngeal pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      30
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      8
      num Events
      14
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      37
      num Events
      76
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      38
      num Events
      17
    term
    Neutropenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
      num Events
      8
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      37
      num Events
      35
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      38
      num Events
      12
    term
    Thrombocytopenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      21
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      3
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      37
      num Events
      45
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      38
      num Events
      19
    term
    Anemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      29
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      37
      num Events
      13
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
      num Events
      2
    term
    Leukopenia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Deep vein thrombosis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Cardiac failure chronic
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Acute myocardial infarction
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Myocardial infarction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Sinus tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
      num Events
      1
    term
    Febrile neutropenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      37
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Anemia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Anemia macrocytic
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
      num Events
      0
    term
    Neutropenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
      num Events
      2
    term
    Respiratory failure
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
      num Events
      1
    term
    Hemoptysis
time Frame
All AEs occurring from the first date of administration of trilaciclib or placebo + E/P therapy through and including 30 calendar days after the last administration of trilaciclib or placebo + E/P therapy were recorded (a minimum of 51 days up to a maximum of 374 days).

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

Preserved source evidence · Not medical advice