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NCT03257631 · STUDY IN CONTEXT

A Study of Pomalidomide Monotherapy for Children and Young Adults With Recurrent or Progressive Primary Brain Tumors

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The percentage of participants who achieved either an objective response, defined as a complete response (CR) or partial response (PR) in the first 6 cycles of treatment (or within 3 cycles for DIPG), or long-term stable disease (SD) defined as SD maintained for ≥ 6 cycles (≥ 3 cycles for DIPG), measured from first dose date. CR: Disappearance of all lesions and no new lesions. PR: A reduction of ≥ 50% in the size of measurable lesions, and/or persistence of non-target lesions with no progression or decrease in size. SD: A decrease of \< 50% or an increase of \< 25% in the size of measurable lesions and no evidence of new lesions, response does not meet the criteria for CR, PR, or progressive disease, and/or the persistence of non-target lesions with no progression or decrease in size. Progressive Disease (PD): ≥ 25% increase in the size of the measurable lesions, or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

The response population consisted of all enrolled participants receiving at least one cycle of pomalidomide if therapy was not discontinued earlier due to progressive disease (PD)

→

secondary · POSTED

Objective response rate was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) within the first 6 cycles of treatment (or within 3 cycles for participants in the DIPG group). Disease assessments were based on MRI and assessed by an independent central review. CR: Disappearance of all lesions and no new lesions. PR: A reduction of ≥ 50% in the size of measurable lesions compared to baseline, and/or the persistence of non-target lesions with no progression or decrease in size. Progressive Disease (PD): ≥ 25% increase in the size of the measurable lesions, or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

The response population consisted of all enrolled participants receiving at least one cycle of pomalidomide if therapy was not discontinued earlier due to progressive disease (PD)

→

secondary · POSTED

Long-term stable disease (SD) rate was defined as the percentage of participants who achieved SD maintained for ≥ 6 cycles (or \> 3 cycles for DIPG), measured from the date of first dose of treatment. Disease assessments were based on MRI and assessed by an independent central review. SD: A decrease of \< 50% or an increase of \< 25% in the size of measurable lesions and no evidence of new lesions, response does not meet the criteria for CR, PR, or progressive disease, and/or the persistence of non-target lesions with no progression or decrease in size. CR: Disappearance of all lesions and no new lesions. PR: A reduction of ≥ 50% in the size of measurable lesions compared to baseline, and/or the persistence of non-target lesions with no progression or decrease in size. Progressive Disease (PD): ≥ 25% increase in the size of the measurable lesions, or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

The response population consisted of all enrolled participants receiving at least one cycle of pomalidomide if therapy was not discontinued earlier due to progressive disease (PD)

→

secondary · POSTED

DoR is defined as the time from the date of the first objective response (complete response \[CR\] or partial response \[PR\]) to disease progression. Participants who did not have disease progression or had not died were censored at the time of their last disease assessment or at the time of start of new anticancer therapy, whichever occurred first. Progressive disease (PD): ≥ 25% increase in the size of the measurable lesions taking as a reference the smallest disease measurement recorded since the start of protocol therapy (nadir), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or if spine MRI and/or lumbar cerebrospinal fluid (CSF) cytology were previously negative and became positive. CR: Disappearance of all lesions and no new lesions. PR: A reduction of ≥ 50% in the size of measurable lesions compared to baseline, and/or the persistence of non-target lesions with no progression or decrease in size.

All enrolled participants with response (PR or CR), regardless of whether they received any treatment or not

→

secondary · POSTED

Progression-free survival was defined as the time from the date of first dose of pomalidomide until the date progressive disease (PD) was first observed or until the date of death due to any cause, whichever occurred first. Participants who did not have PD or had not died at the time of analysis were censored at the time of their last disease assessment or at the start of new anticancer therapy, whichever occurred first. Progressive Disease (PD): ≥ 25% increase in the size of the measurable lesions taking as a reference the smallest disease measurement recorded since the start of protocol therapy (nadir), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or if spine MRI and/or lumbar CSF cytology were previously negative and became positive.

The intent-to-treat population includes all enrolled participants, regardless of whether they received any treatment or not

→

secondary · POSTED

Overall survival was defined as the time from the date of the first dose to the date of death (any cause). Participants who were alive were censored at the last known time that the participant was alive.

The intent-to-treat population includes all enrolled participants, regardless of whether they received any treatment or not

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors-recurrent-31ec95fa
nct id
NCT03257631
trial label
A Study of Pomalidomide Monotherapy for Children and Young Adults With Recurrent or Progressive Primary Brain Tumors
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
4
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    outcome key
    om-0000
    source section id
    NCT03257631-om-0000
    source outcome index
    0
    endpoint
    Percentage of Participants With an Objective Response and Long-term Stable Disease
    endpoint definition
    The percentage of participants who achieved either an objective response, defined as a complete response (CR) or partial response (PR) in the first 6 cycles of treatment (or within 3 cycles for DIPG), or long-term stable disease (SD) defined as SD maintained for ≥ 6 cycles (≥ 3 cycles for DIPG), measured from first dose date. CR: Disappearance of all lesions and no new lesions. PR: A reduction of ≥ 50% in the size of measurable lesions, and/or persistence of non-target lesions with no progression or decrease in size. SD: A decrease of \< 50% or an increase of \< 25% in the size of measurable lesions and no evidence of new lesions, response does not meet the criteria for CR, PR, or progressive disease, and/or the persistence of non-target lesions with no progression or decrease in size. Progressive Disease (PD): ≥ 25% increase in the size of the measurable lesions, or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
    time origin
    6 months (first 6 cycles) or 3 months (first 3 cycles) for participants in the DIPG group
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The response population consisted of all enrolled participants receiving at least one cycle of pomalidomide if therapy was not discontinued earlier due to progressive disease (PD)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    outcome key
    om-0001
    source section id
    NCT03257631-om-0001
    source outcome index
    1
    endpoint
    Percentage of Participants Who Achieved an Objective Response (ORR)
    endpoint definition
    Objective response rate was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) within the first 6 cycles of treatment (or within 3 cycles for participants in the DIPG group). Disease assessments were based on MRI and assessed by an independent central review. CR: Disappearance of all lesions and no new lesions. PR: A reduction of ≥ 50% in the size of measurable lesions compared to baseline, and/or the persistence of non-target lesions with no progression or decrease in size. Progressive Disease (PD): ≥ 25% increase in the size of the measurable lesions, or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
    time origin
    6 months (first 6 cycles) or 3 months (first 3 cycles) for participants in the DIPG group
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The response population consisted of all enrolled participants receiving at least one cycle of pomalidomide if therapy was not discontinued earlier due to progressive disease (PD)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    outcome key
    om-0002
    source section id
    NCT03257631-om-0002
    source outcome index
    2
    endpoint
    Percentage of Participants With Long-term Stable Disease
    endpoint definition
    Long-term stable disease (SD) rate was defined as the percentage of participants who achieved SD maintained for ≥ 6 cycles (or \> 3 cycles for DIPG), measured from the date of first dose of treatment. Disease assessments were based on MRI and assessed by an independent central review. SD: A decrease of \< 50% or an increase of \< 25% in the size of measurable lesions and no evidence of new lesions, response does not meet the criteria for CR, PR, or progressive disease, and/or the persistence of non-target lesions with no progression or decrease in size. CR: Disappearance of all lesions and no new lesions. PR: A reduction of ≥ 50% in the size of measurable lesions compared to baseline, and/or the persistence of non-target lesions with no progression or decrease in size. Progressive Disease (PD): ≥ 25% increase in the size of the measurable lesions, or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
    time origin
    6 months (first 6 cycles) or 3 months (first 3 cycles) for participants in the DIPG group
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The response population consisted of all enrolled participants receiving at least one cycle of pomalidomide if therapy was not discontinued earlier due to progressive disease (PD)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    outcome key
    om-0003
    source section id
    NCT03257631-om-0003
    source outcome index
    3
    endpoint
    Duration of Response (DoR)
    endpoint definition
    DoR is defined as the time from the date of the first objective response (complete response \[CR\] or partial response \[PR\]) to disease progression. Participants who did not have disease progression or had not died were censored at the time of their last disease assessment or at the time of start of new anticancer therapy, whichever occurred first. Progressive disease (PD): ≥ 25% increase in the size of the measurable lesions taking as a reference the smallest disease measurement recorded since the start of protocol therapy (nadir), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or if spine MRI and/or lumbar cerebrospinal fluid (CSF) cytology were previously negative and became positive. CR: Disappearance of all lesions and no new lesions. PR: A reduction of ≥ 50% in the size of measurable lesions compared to baseline, and/or the persistence of non-target lesions with no progression or decrease in size.
    time origin
    From the first dose of pomalidomide to the date of the first documented tumor progression or death due to any cause, whichever occurs first (Up to 71 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All enrolled participants with response (PR or CR), regardless of whether they received any treatment or not
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    outcome key
    om-0004
    source section id
    NCT03257631-om-0004
    source outcome index
    4
    endpoint
    Kaplan-Meier Estimate of Progression-Free Survival (PFS)
    endpoint definition
    Progression-free survival was defined as the time from the date of first dose of pomalidomide until the date progressive disease (PD) was first observed or until the date of death due to any cause, whichever occurred first. Participants who did not have PD or had not died at the time of analysis were censored at the time of their last disease assessment or at the start of new anticancer therapy, whichever occurred first. Progressive Disease (PD): ≥ 25% increase in the size of the measurable lesions taking as a reference the smallest disease measurement recorded since the start of protocol therapy (nadir), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or if spine MRI and/or lumbar CSF cytology were previously negative and became positive.
    time origin
    From the first dose of pomalidomide to the date of the first documented tumor progression or death due to any cause, whichever occurs first (Up to 71 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The intent-to-treat population includes all enrolled participants, regardless of whether they received any treatment or not
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    outcome key
    om-0005
    source section id
    NCT03257631-om-0005
    source outcome index
    5
    endpoint
    Kaplan-Meier Estimate of Overall Survival (OS)
    endpoint definition
    Overall survival was defined as the time from the date of the first dose to the date of death (any cause). Participants who were alive were censored at the last known time that the participant was alive.
    time origin
    From the first dose of pomalidomide to the date of death due to any cause (Up to 71 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The intent-to-treat population includes all enrolled participants, regardless of whether they received any treatment or not
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Diffuse Intrinsic Pontine Glioma
    regimen
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03257631-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Ependymoma
    regimen
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03257631-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    outcome key
    om-0000
    arm key
    OG002
    arm label
    High-grade Glioma
    regimen
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03257631-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Medulloblastoma
    regimen
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03257631-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Diffuse Intrinsic Pontine Glioma
    regimen
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03257631-om-0001#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Ependymoma
    regimen
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03257631-om-0001#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    outcome key
    om-0001
    arm key
    OG002
    arm label
    High-grade Glioma
    regimen
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03257631-om-0001#groups/OG002
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    outcome key
    om-0001
    arm key
    OG003
    arm label
    Medulloblastoma
    regimen
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03257631-om-0001#groups/OG003
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Diffuse Intrinsic Pontine Glioma
    regimen
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03257631-om-0002#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Ependymoma
    regimen
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03257631-om-0002#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    outcome key
    om-0002
    arm key
    OG002
    arm label
    High-grade Glioma
    regimen
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    analyzed count
    19
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03257631-om-0002#groups/OG002
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    outcome key
    om-0002
    arm key
    OG003
    arm label
    Medulloblastoma
    regimen
    Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03257631-om-0002#groups/OG003
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    harm key
    EG000
    source section id
    NCT03257631-ae
    event group key
    EG000
    event group label
    Diffuse Intrinsic Pontine Glioma
    serious affected
    9
    serious at risk
    11
    other affected
    11
    other at risk
    11
    frequency threshold
    5
    collection period
    Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 72 months). SAEs and other AEs were assessed from first dose until 28 days after last dose (up to approximately 72 months).
    event definition
    The number at Risk for All-cause mortality represents all enrolled participants, regardless of whether the participant received study treatment or not. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants who received at least 1 dose of pomalidomide.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    harm key
    EG001
    source section id
    NCT03257631-ae
    event group key
    EG001
    event group label
    Ependymoma
    serious affected
    4
    serious at risk
    9
    other affected
    8
    other at risk
    9
    frequency threshold
    5
    collection period
    Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 72 months). SAEs and other AEs were assessed from first dose until 28 days after last dose (up to approximately 72 months).
    event definition
    The number at Risk for All-cause mortality represents all enrolled participants, regardless of whether the participant received study treatment or not. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants who received at least 1 dose of pomalidomide.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    harm key
    EG002
    source section id
    NCT03257631-ae
    event group key
    EG002
    event group label
    High-grade Glioma
    serious affected
    14
    serious at risk
    22
    other affected
    20
    other at risk
    22
    frequency threshold
    5
    collection period
    Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 72 months). SAEs and other AEs were assessed from first dose until 28 days after last dose (up to approximately 72 months).
    event definition
    The number at Risk for All-cause mortality represents all enrolled participants, regardless of whether the participant received study treatment or not. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants who received at least 1 dose of pomalidomide.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT03257631
    harm key
    EG003
    source section id
    NCT03257631-ae
    event group key
    EG003
    event group label
    Medulloblastoma
    serious affected
    4
    serious at risk
    10
    other affected
    9
    other at risk
    10
    frequency threshold
    5
    collection period
    Participants were assessed for all-cause mortality from their first dose until their study completion (up to approximately 72 months). SAEs and other AEs were assessed from first dose until 28 days after last dose (up to approximately 72 months).
    event definition
    The number at Risk for All-cause mortality represents all enrolled participants, regardless of whether the participant received study treatment or not. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants who received at least 1 dose of pomalidomide.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice