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← Diffuse Intrinsic Pontine Glioma (DIPG)

NCT01189266 · STUDY IN CONTEXT

Vorinostat and Radiation Therapy Followed by Maintenance Therapy With Vorinostat in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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 dose of vorinostat in mg/sqm/day to be administered with combination chemotherapy and radiation therapy

All patients enrolled on arm 1 and 2 who received at least 85% of the planned doses of radiation therapy and chemotherapy in the chemoradiotherapy portion of the study or who experienced DLT after after receiving at least one dose of chemoradio therapy and completing 7 weeks fo follow-up.

→

primary · POSTED

Time from enrollment to disease progression, diagnosis of a second malignant neoplasm, death or last follow-up, whichever occurs first.

One patient enrolled on Arm 3 was withdrawn from study prior to the start of treatment.

→

primary · POSTED

Proportion of patients who experience any grade 3 or higher CTC AE Version 4 adverse experience

All patients enrolled on Arm 1 and 2 received at least one dose of chemoradiation therapy. Two patients enrolled on arm 3 did not receive protocol therapy prior to date of removal from protocol therapy.

→

primary · POSTED

Proportion of patients who experience any grade 3 or higher CTC AE Version 4 adverse experience

All patients enrolled on arm 1 and 2 received at least one dose of maintenance therapy. Seven patients enrolled on arm 3 did not receive maintenance therapy prior to date of removal from protocol therapy.

→

secondary · POSTED

Time from enrollment to death or last follow-up, whichever occurs first.

One patient enrolled on Arm 3 was withdrawn from study prior to the start of treatment.

→

secondary · POSTED

Degree of acetylation in peripheral blood monocytes will be divided into quartiles and coded as none, mild, moderation or marked.

Due to budgetary issues the planned laboratory testing was not performed and no data were collected

→

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-diffuse-intrinsic-pontine-glioma-dipg
nct id
NCT01189266
trial label
Vorinostat and Radiation Therapy Followed by Maintenance Therapy With Vorinostat in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
3
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    outcome key
    om-0000
    source section id
    NCT01189266-om-0000
    source outcome index
    0
    endpoint
    Maximum Tolerated Dose (MTD) of Vorinostat
    endpoint definition
    The dose of vorinostat in mg/sqm/day to be administered with combination chemotherapy and radiation therapy
    time origin
    Planned 7 weeks during chemoradiotherapy
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All patients enrolled on arm 1 and 2 who received at least 85% of the planned doses of radiation therapy and chemotherapy in the chemoradiotherapy portion of the study or who experienced DLT after after receiving at least one dose of chemoradio therapy and completing 7 weeks fo follow-up.
    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-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    outcome key
    om-0001
    source section id
    NCT01189266-om-0001
    source outcome index
    1
    endpoint
    Event-Free Survival
    endpoint definition
    Time from enrollment to disease progression, diagnosis of a second malignant neoplasm, death or last follow-up, whichever occurs first.
    time origin
    2 years after study enrollment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One patient enrolled on Arm 3 was withdrawn from study prior to the start of treatment.
    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-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    outcome key
    om-0002
    source section id
    NCT01189266-om-0002
    source outcome index
    2
    endpoint
    Incidence of Toxicity During Chemoradiation Therapy
    endpoint definition
    Proportion of patients who experience any grade 3 or higher CTC AE Version 4 adverse experience
    time origin
    Planned 7 weeks during chemoradiotherapy
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All patients enrolled on Arm 1 and 2 received at least one dose of chemoradiation therapy. Two patients enrolled on arm 3 did not receive protocol therapy prior to date of removal from protocol therapy.
    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-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    outcome key
    om-0003
    source section id
    NCT01189266-om-0003
    source outcome index
    3
    endpoint
    Incidence of Toxicity During Maintenance Therapy
    endpoint definition
    Proportion of patients who experience any grade 3 or higher CTC AE Version 4 adverse experience
    time origin
    Planned 12 months of maintenance with Vorinostat
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All patients enrolled on arm 1 and 2 received at least one dose of maintenance therapy. Seven patients enrolled on arm 3 did not receive maintenance therapy prior to date of removal from protocol therapy.
    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-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    outcome key
    om-0004
    source section id
    NCT01189266-om-0004
    source outcome index
    4
    endpoint
    Overall Survival
    endpoint definition
    Time from enrollment to death or last follow-up, whichever occurs first.
    time origin
    2 years after study enrollment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One patient enrolled on Arm 3 was withdrawn from study prior to the start of treatment.
    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-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    outcome key
    om-0005
    source section id
    NCT01189266-om-0005
    source outcome index
    5
    endpoint
    Change in H3 and H4 Acetylation Levels in PBMCs
    endpoint definition
    Degree of acetylation in peripheral blood monocytes will be divided into quartiles and coded as none, mild, moderation or marked.
    time origin
    Baseline to up to 7 weeks
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Due to budgetary issues the planned laboratory testing was not performed and no data were collected
    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-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    outcome key
    om-0000
    arm key
    OG000
    arm label
    All Phase 1 Study Participants
    regimen
    Arm 1, Phase 1 participants received vorinostat at 180 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Arm 2, Phase 1 participants received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks).
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01189266-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm 1, Phase I Vorinostat 180 mg/m^2
    regimen
    Patients in phase I received vorinostat at 180 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01189266-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm 2, Phase I Vorinostat 230 mg/m^2
    regimen
    Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01189266-om-0001#groups/OG001
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2
    regimen
    Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/ day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01189266-om-0001#groups/OG002
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm 1, Phase I Vorinostat 180 mg/m^2
    regimen
    Patients in phase I received vorinostat at 180 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01189266-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm 2, Phase I Vorinostat 230 mg/m^2
    regimen
    Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01189266-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2
    regimen
    Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/ day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
    analyzed count
    65
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01189266-om-0002#groups/OG002
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm 1, Phase I Vorinostat 180 mg/m^2
    regimen
    Patients in phase I received vorinostat at 180 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01189266-om-0003#groups/OG000
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Arm 2, Phase I Vorinostat 230 mg/m^2
    regimen
    Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01189266-om-0003#groups/OG001
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    outcome key
    om-0003
    arm key
    OG002
    arm label
    Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2
    regimen
    Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/ day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
    analyzed count
    60
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01189266-om-0003#groups/OG002
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Arm 1, Phase I Vorinostat 180 mg/m^2
    regimen
    Patients in phase I received vorinostat at 180 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01189266-om-0004#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Arm 2, Phase I Vorinostat 230 mg/m^2
    regimen
    Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01189266-om-0004#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    harm key
    EG000
    source section id
    NCT01189266-ae
    event group key
    EG000
    event group label
    Arm 1 Phase I Vorinostat 180 mg/m^2
    serious affected
    6
    serious at risk
    6
    other affected
    6
    other at risk
    6
    frequency threshold
    0
    collection period
    Up to 2 years
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
    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-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    harm key
    EG001
    source section id
    NCT01189266-ae
    event group key
    EG001
    event group label
    Arm 2 Phase 1 Vorinostat 230 mg/m^2
    serious affected
    5
    serious at risk
    6
    other affected
    6
    other at risk
    6
    frequency threshold
    0
    collection period
    Up to 2 years
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
    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-diffuse-intrinsic-pontine-glioma-dipg
    nct id
    NCT01189266
    harm key
    EG002
    source section id
    NCT01189266-ae
    event group key
    EG002
    event group label
    Arm 3 Phase II Evaluation Vorinostat 230 mg/m^2
    serious affected
    55
    serious at risk
    65
    other affected
    51
    other at risk
    65
    frequency threshold
    0
    collection period
    Up to 2 years
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
    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