Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02716805 · OUTCOME

Number of Subjects With Treatment-emergent Adverse Events

Phase 1 Study of Tremelimumab, Durvalumab, High-dose Chemotherapy, + Autologous Stem Cell Transplant · Source last updated 2022-10-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
up to 14 months

What was measured

Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from the time of enrollment through the end of the study period. DLTs were assessed from the first dose of study drug through the Cycle 2 administration of tremelimumab ± durvalumab post ASCT. DLTs were defined per protocol as lack of neutrophil/platelet engraftment by Day 30 post ASCT; Grade 5 toxicity (treatment-related death); Grade 4 non-hematological toxicity; Grade 3 non-hematological toxicity (with exclusions); isolated Grade 3 electrolyte abnormalities; or immune-related AEs resulting in discontinuation of treatment.

Analysis population: All treated subjects.

Groups in this outcome

Cohort 1

"Late" post-ASCT treatment (tremelimumab alone in Cycles 1-2, durvalumab alone in Cycles 3+)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort 16

Reported measurements

Any TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 16Not reportedNot reportedNot reportedNot reported
Maximum grade 2 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 12Not reportedNot reportedNot reportedNot reported
Maximum grade 4 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 14Not reportedNot reportedNot reportedNot reported
Immune-related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 11Not reportedNot reportedNot reportedNot reported
Tremelimumab-related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 15Not reportedNot reportedNot reportedNot reported
Durvalumab-related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 11Not reportedNot reportedNot reportedNot reported
Serious TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 11Not reportedNot reportedNot reportedNot reported
TEAE Leading to Treatment Discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 10Not reportedNot reportedNot reportedNot reported
TEAE Meeting DLT Criteria
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Any TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Maximum grade 2 TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Maximum grade 4 TEAE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Immune-related TEAE
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Tremelimumab-related TEAE
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Durvalumab-related TEAE
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Serious TEAE
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    TEAE Leading to Treatment Discontinuation
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    TEAE Meeting DLT Criteria
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from the time of enrollment through the end of the study period. DLTs were assessed from the first dose of study drug through the Cycle 2 administration of tremelimumab ± durvalumab post ASCT. DLTs were defined per protocol as lack of neutrophil/platelet engraftment by Day 30 post ASCT; Grade 5 toxicity (treatment-related death); Grade 4 non-hematological toxicity; Grade 3 non-hematological toxicity (with exclusions); isolated Grade 3 electrolyte abnormalities; or immune-related AEs resulting in discontinuation of treatment.
groups
  1. description
    "Late" post-ASCT treatment (tremelimumab alone in Cycles 1-2, durvalumab alone in Cycles 3+)
    id
    OG000
    title
    Cohort 1
param Type
COUNT_OF_PARTICIPANTS
population Description
All treated subjects.
reporting Status
POSTED
time Frame
up to 14 months
title
Number of Subjects With Treatment-emergent Adverse Events
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice