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NCT02000427 · OUTCOME

Number of Participants With Adverse Events

Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia · Source last updated 2024-05-28

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From the first dose of blinatumomab until 30 days after the last dose, up to the cut-off date of 20 May 2015; the median duration of treatment was 53.8 days.

What was measured

Adverse events (AEs) were graded for severity according to the CTCAE version 4.0, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to blinatumomab based on response to the question: Is there a reasonable possibility that the event may have been caused by blinatumomab or other protocol-specified therapies/procedures?

Analysis population: All participants who received an infusion of blinatumomab

Groups in this outcome

Blinatumomab

Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment.

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

Analysis denominator · Participants

GroupSource count
Blinatumomab45

Reported measurements

Any adverse event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab45Not reportedNot reportedNot reportedNot reported
AE grade ≥ 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab37Not reportedNot reportedNot reportedNot reported
AE grade ≥ 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab18Not reportedNot reportedNot reportedNot reported
Serious adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab28Not reportedNot reportedNot reportedNot reported
Leading to discontinuation of blinatumomab
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab3Not reportedNot reportedNot reportedNot reported
Leading to interruption of blinatumomab
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab16Not reportedNot reportedNot reportedNot reported
Fatal adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab5Not reportedNot reportedNot reportedNot reported
Treatment-related adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab41Not reportedNot reportedNot reportedNot reported
Treatment-related AE grade ≥ 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab20Not reportedNot reportedNot reportedNot reported
Treatment-related AE grade ≥ 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab7Not reportedNot reportedNot reportedNot reported
Treatment-related serious adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab12Not reportedNot reportedNot reportedNot reported
TRAE leading to discontinuation of blinatumomab
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab2Not reportedNot reportedNot reportedNot reported
TRAE leading to interruption of blinatumomab
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab12Not reportedNot reportedNot reportedNot reported
Treatment-related fatal adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        45
    title
    Any adverse event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        37
    title
    AE grade ≥ 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    AE grade ≥ 4
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        28
    title
    Serious adverse events
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Leading to discontinuation of blinatumomab
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    Leading to interruption of blinatumomab
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Fatal adverse events
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        41
    title
    Treatment-related adverse events
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    Treatment-related AE grade ≥ 3
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Treatment-related AE grade ≥ 4
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    Treatment-related serious adverse events
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    TRAE leading to discontinuation of blinatumomab
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    units
    Participants
description
Adverse events (AEs) were graded for severity according to the CTCAE version 4.0, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to blinatumomab based on response to the question: Is there a reasonable possibility that the event may have been caused by blinatumomab or other protocol-specified therapies/procedures?
groups
  1. description
    Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment.
    id
    OG000
    title
    Blinatumomab
param Type
NUMBER
population Description
All participants who received an infusion of blinatumomab
reporting Status
POSTED
time Frame
From the first dose of blinatumomab until 30 days after the last dose, up to the cut-off date of 20 May 2015; the median duration of treatment was 53.8 days.
title
Number of Participants With Adverse Events
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice