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NCT02362035 · OUTCOME

Number of Participants With Any Study-Drug Related AE

ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies · Source last updated 2026-05-13

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

Measure
NUMBER
Unit
Number of participants
Interval / dispersion
Not reported
Time frame
104 weeks

What was measured

Study drug-related AEs were those assessed by investigator as related to study treatment.

Analysis population: All participants in this study received both study drugs and were therefore analyzed together as a single treatment arm. Participants receiving the different regimens were not analyzed separately by regimen, as the study was designed to assess the safety of the combination study treatment.

Groups in this outcome

Acalabrutinib + Pembrolizumab

All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.

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

Analysis denominator · Participants

GroupSource count
Acalabrutinib + Pembrolizumab161

Reported measurements

Source class 1
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Acalabrutinib + Pembrolizumab142Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        142
denoms
  1. counts
    1. group Id
      OG000
      value
      161
    units
    Participants
description
Study drug-related AEs were those assessed by investigator as related to study treatment.
groups
  1. description
    All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
    id
    OG000
    title
    Acalabrutinib + Pembrolizumab
param Type
NUMBER
population Description
All participants in this study received both study drugs and were therefore analyzed together as a single treatment arm. Participants receiving the different regimens were not analyzed separately by regimen, as the study was designed to assess the safety of the combination study treatment.
reporting Status
POSTED
time Frame
104 weeks
title
Number of Participants With Any Study-Drug Related AE
type
PRIMARY
unit Of Measure
Number of participants

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

Preserved source evidence · Not medical advice