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NCT01207388 · OUTCOME

Number of Participants With Adverse Events

Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL) · Source last updated 2020-02-10

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 last dose; the median treatment duration was 55 days.

What was measured

Adverse events (AEs) were evaluated for severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death. The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab. An AE was considered "serious" if it resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions, was a congenital anomaly or birth defect or was a medically important condition.

Analysis population: All participants who received any infusion of blinatumomab.

Groups in this outcome

Blinatumomab

Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 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
Blinatumomab116

Reported measurements

Any adverse event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab116Not reportedNot reportedNot reportedNot reported
Serious adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab73Not reportedNot reportedNot reportedNot reported
Adverse events ≥ CTC grade 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab71Not reportedNot reportedNot reportedNot reported
Adverse events ≥ CTC grade 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab33Not reportedNot reportedNot reportedNot reported
Fatal adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab2Not reportedNot reportedNot reportedNot reported
AEs leading to discontinuation of blinatumomab
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab20Not reportedNot reportedNot reportedNot reported
AEs leading to interruption of blinatumomab
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab36Not reportedNot reportedNot reportedNot reported
Treatment-related adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab112Not reportedNot reportedNot reportedNot reported
Treatment-related serious adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab60Not reportedNot reportedNot reportedNot reported
Treatment-related adverse events ≥ CTC grade 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab60Not reportedNot reportedNot reportedNot reported
Treatment-related adverse events ≥ CTC grade 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab26Not 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
        116
    title
    Any adverse event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        73
    title
    Serious adverse events
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        71
    title
    Adverse events ≥ CTC grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        33
    title
    Adverse events ≥ CTC grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Fatal adverse events
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    AEs leading to discontinuation of blinatumomab
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        36
    title
    AEs leading to interruption of blinatumomab
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        112
    title
    Treatment-related adverse events
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        60
    title
    Treatment-related serious adverse events
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        60
    title
    Treatment-related adverse events ≥ CTC grade 3
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        26
    title
    Treatment-related adverse events ≥ CTC grade 4
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Treatment-related fatal adverse events
denoms
  1. counts
    1. group Id
      OG000
      value
      116
    units
    Participants
description
Adverse events (AEs) were evaluated for severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death. The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab. An AE was considered "serious" if it resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions, was a congenital anomaly or birth defect or was a medically important condition.
groups
  1. description
    Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
    id
    OG000
    title
    Blinatumomab
param Type
NUMBER
population Description
All participants who received any infusion of blinatumomab.
reporting Status
POSTED
time Frame
From the first dose of blinatumomab until 30 days after last dose; the median treatment duration was 55 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