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NCT03272633 · ADVERSE EVENTS

Adverse events

Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies · Source last updated 2023-06-26

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Up to 8 weeks after last protocol treatment
Other-event reporting threshold
5%

no data was collected. Adverse Events Description text only refers to the Cohort II No participants were enrolled in Cohort I, so no adverse events were monitored/assessed for Cohort I

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort I (Initial IHC Within 42 Days)

Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies

0 / 00 / 00 / 0
Cohort II (Initial IHC Within 70 Days or After Relapse)

Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies

0 / 22 / 20 / 2

Group identifiers: EG000: Cohort I (Initial IHC Within 42 Days) · EG001: Cohort II (Initial IHC Within 70 Days or After Relapse)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Musculoskeletal and connective tissue disorders

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2
    term
    General disorders and administration site conditions
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2
      num Events
      5
    term
    Investigations
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Eye disorders
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Metabolism and nutrition disorders
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Nervous system disorders
Complete source fields
description
no data was collected. Adverse Events Description text only refers to the Cohort II No participants were enrolled in Cohort I, so no adverse events were monitored/assessed for Cohort I
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies
    id
    EG000
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Cohort I (Initial IHC Within 42 Days)
  2. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies
    id
    EG001
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Cohort II (Initial IHC Within 70 Days or After Relapse)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2
    term
    General disorders and administration site conditions
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2
      num Events
      5
    term
    Investigations
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Eye disorders
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Metabolism and nutrition disorders
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Nervous system disorders
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      0
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Musculoskeletal and connective tissue disorders
time Frame
Up to 8 weeks after last protocol treatment

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

Preserved source evidence · Not medical advice