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NCT02554812 · OUTCOME

Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination C

A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) · Source last updated 2024-07-30

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
Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 1.8 years)

What was measured

TEAEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period. Treatment-related AEs was any untoward medical occurrence attributed to study drug in a participant who received study drug. Per NCI CTCAE v4.03: Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment; Grade 4 (Life-threatening) events caused participant to be in imminent danger of death; Grade 5 (Death) events=death related to an AE. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Analysis population: The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one study treatment, the participant were classified according to the first treatment received.

Groups in this outcome

Combination C Phase 1b: PD 0360324 50 mg + Avelumab

During Phase 1b participants received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.

Combination C Phase 1b: PD 0360324 100 mg + Avelumab

During Phase 1b participants received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Combination C Phase 1b: PD 0360324 150 mg + Avelumab

During Phase 1b participants received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

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

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab10
Combination C Phase 1b: PD 0360324 100 mg + Avelumab8
Combination C Phase 1b: PD 0360324 150 mg + Avelumab6

Reported measurements

TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab9Not reportedNot reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab8Not reportedNot reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab6Not reportedNot reportedNot reportedNot reported
Grade >=3 TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab5Not reportedNot reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab4Not reportedNot reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab6Not reportedNot reportedNot reportedNot reported
Serious TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab4Not reportedNot reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab3Not reportedNot reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab4Not reportedNot reportedNot reportedNot reported
Treatment related TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab7Not reportedNot reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab6Not reportedNot reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        6
    title
    TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        6
    title
    Grade >=3 TEAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        4
    title
    Serious TEAEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        5
    title
    Treatment related TEAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      6
    units
    Participants
description
TEAEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period. Treatment-related AEs was any untoward medical occurrence attributed to study drug in a participant who received study drug. Per NCI CTCAE v4.03: Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment; Grade 4 (Life-threatening) events caused participant to be in imminent danger of death; Grade 5 (Death) events=death related to an AE. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
groups
  1. description
    During Phase 1b participants received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
    id
    OG000
    title
    Combination C Phase 1b: PD 0360324 50 mg + Avelumab
  2. description
    During Phase 1b participants received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
    id
    OG001
    title
    Combination C Phase 1b: PD 0360324 100 mg + Avelumab
  3. description
    During Phase 1b participants received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
    id
    OG002
    title
    Combination C Phase 1b: PD 0360324 150 mg + Avelumab
param Type
COUNT_OF_PARTICIPANTS
population Description
The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one study treatment, the participant were classified according to the first treatment received.
reporting Status
POSTED
time Frame
Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 1.8 years)
title
Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination C
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice