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← Primitive Neuroectodermal Tumor

NCT02372006 · STUDY IN CONTEXT

Trial of Afatinib in Pediatric Tumours

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 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

Number of participants with objective response for maximum tolerated dose expansion (MTD) cohort was reported. The objective response was defined as a best overall response of complete response or partial response based on investigator's assessment according to the institutional response evaluation criteria for the given tumour type, assessed every 8 weeks until progression.

Treated set (TS): This patient set included all patients enrolled in the trial who were documented to have taken at least one dose of study medication.

→

primary · POSTED

Area under the curve over dosing interval τ at steady state (AUCτ,ss) for Dose finding part was reported.

Pharmacokinetics (PK) analysis set (PKS): This patient set included all patients in the TS who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis.

→

primary · POSTED

Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) for Dose finding part was reported.

Pharmacokinetics (PK) analysis set (PKS): This patient set included all patients in the TS who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis.

→

primary · POSTED

Number of participants with Dose Limiting Toxicity adverse events for Dose finding part was reported.

Treated set (TS): This patient set included all patients enrolled in the trial who were documented to have taken at least one dose of study medication.

→

secondary · POSTED

Number of participants with objective response for Dose finding part was reported. The objective response was defined as a best overall response of complete response or partial response based on investigator's assessment according to the institutional response evaluation criteria for the given tumour type, assessed every 8 weeks until progression.

Treated set (TS): This patient set included all patients enrolled in the trial who were documented to have taken at least one dose of study medication.

→

secondary · POSTED

Progression free survival for the MTD expansion cohorts was reported. Progression free survival (PFS) was defined as the duration from the date of first treatment until the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of last adequate tumour assessment.

Treated set (TS): This patient set included all patients enrolled in the trial who were documented to have taken at least one dose of study medication.

→

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-primitive-neuroectodermal-tumor
nct id
NCT02372006
trial label
Trial of Afatinib in Pediatric Tumours
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
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
3
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    outcome key
    om-0000
    source section id
    NCT02372006-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Objective Response - Maximum Tolerated Dose Expansion (MTD) Cohort
    endpoint definition
    Number of participants with objective response for maximum tolerated dose expansion (MTD) cohort was reported. The objective response was defined as a best overall response of complete response or partial response based on investigator's assessment according to the institutional response evaluation criteria for the given tumour type, assessed every 8 weeks until progression.
    time origin
    Assessed every 8 weeks until progression of disease, up to 336 days.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Treated set (TS): This patient set included all patients enrolled in the trial who were documented to have taken at least one dose of study medication.
    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-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    outcome key
    om-0001
    source section id
    NCT02372006-om-0001
    source outcome index
    1
    endpoint
    Area Under the Curve Over Dosing Interval τ at Steady State (AUCτ,ss) - Dose Finding Part
    endpoint definition
    Area under the curve over dosing interval τ at steady state (AUCτ,ss) for Dose finding part was reported.
    time origin
    Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration at steady state on Day 8.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Pharmacokinetics (PK) analysis set (PKS): This patient set included all patients in the TS who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis.
    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-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    outcome key
    om-0002
    source section id
    NCT02372006-om-0002
    source outcome index
    2
    endpoint
    Maximum Measured Concentration of the Analyte in Plasma at Steady State (Cmax,ss) - Dose Finding Part
    endpoint definition
    Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) for Dose finding part was reported.
    time origin
    Pre-dose before afatinib administration then 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h and 24 h after administration at steady state on Day 8.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Pharmacokinetics (PK) analysis set (PKS): This patient set included all patients in the TS who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Only participants with non-missing results were included in the analysis.
    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-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    outcome key
    om-0003
    source section id
    NCT02372006-om-0003
    source outcome index
    3
    endpoint
    Number of Participants With Dose Limiting Toxicity Adverse Events - Dose Finding Part
    endpoint definition
    Number of participants with Dose Limiting Toxicity adverse events for Dose finding part was reported.
    time origin
    During the first course (28 days) of treatment.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Treated set (TS): This patient set included all patients enrolled in the trial who were documented to have taken at least one dose of study medication.
    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-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    outcome key
    om-0004
    source section id
    NCT02372006-om-0004
    source outcome index
    4
    endpoint
    Number of Participants With Objective Response - Dose Finding Part
    endpoint definition
    Number of participants with objective response for Dose finding part was reported. The objective response was defined as a best overall response of complete response or partial response based on investigator's assessment according to the institutional response evaluation criteria for the given tumour type, assessed every 8 weeks until progression.
    time origin
    Assessed every 8 weeks until progression of disease, up to 336 days.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Treated set (TS): This patient set included all patients enrolled in the trial who were documented to have taken at least one dose of study medication.
    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-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    outcome key
    om-0005
    source section id
    NCT02372006-om-0005
    source outcome index
    5
    endpoint
    Progression Free Survival - Maximum Tolerated Dose (MTD) Expansion Cohort
    endpoint definition
    Progression free survival for the MTD expansion cohorts was reported. Progression free survival (PFS) was defined as the duration from the date of first treatment until the date of the first documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of last adequate tumour assessment.
    time origin
    From the first treatment until date of first progression or death, up to 336 days.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Treated set (TS): This patient set included all patients enrolled in the trial who were documented to have taken at least one dose of study medication.
    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-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0
    regimen
    Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area \[BSA\] using allometric scaling): Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets. Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment. Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter.
    analyzed count
    39
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372006-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Dose Finding - Level 0
    regimen
    Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area \[BSA\] using allometric scaling): Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets. Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment. Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter.
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372006-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Dose Finding - Level 1
    regimen
    Afatinib, dose level 1. (Once daily at 100% of the recommended adult dose per m2 body surface area \[BSA\] using allometric scaling): Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets. Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment. Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter.
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372006-om-0001#groups/OG001
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Dose Finding - Level 0
    regimen
    Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area \[BSA\] using allometric scaling): Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets. Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment. Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter.
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372006-om-0002#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Dose Finding - Level 1
    regimen
    Afatinib, dose level 1. (Once daily at 100% of the recommended adult dose per m2 body surface area \[BSA\] using allometric scaling): Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets. Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment. Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter.
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372006-om-0002#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Dose Finding - Level 0
    regimen
    Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area \[BSA\] using allometric scaling): Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets. Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment. Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter.
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372006-om-0003#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Dose Finding - Level 1
    regimen
    Afatinib, dose level 1. (Once daily at 100% of the recommended adult dose per m2 body surface area \[BSA\] using allometric scaling): Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets. Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment. Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372006-om-0003#groups/OG001
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Dose Finding - Level 0
    regimen
    Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area \[BSA\] using allometric scaling): Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets. Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment. Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter.
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372006-om-0004#groups/OG000
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Dose Finding - Level 1
    regimen
    Afatinib, dose level 1. (Once daily at 100% of the recommended adult dose per m2 body surface area \[BSA\] using allometric scaling): Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets. Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment. Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372006-om-0004#groups/OG001
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0
    regimen
    Afatinib, dose level 0. (Once daily at 80% of the recommended adult dose per m2 body surface area \[BSA\] using allometric scaling): Oral solid single-unit film-coated tablets for pediatric patients who are able to swallow them. Oral liquid formulation for patients who cannot swallow the film-coated tablets, or for doses which cannot be achieved by the film-coated tablets, or for pediatric patients who did not accept the film-coated tablets. Therapy with afatinib continued as long as the individual patient benefited from the therapy, did not develop secondary malignancy, and did not meet one of the criteria requiring withdrawal from treatment. Afatinib in film-coated tablet form can be given in tablets of 20, 30, 40 and 50 mg. The dose in film-coated tablets is related to the free base equivalent to afatinib. The dose of afatinib as capsule and solvent for oral solution is given as a 200 mg capsule to be dissolved in aqueous solvent (2 capsules per 100 milliliter solvent) i.e. 4 milligram per milliliter.
    analyzed count
    39
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02372006-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    harm key
    EG000
    source section id
    NCT02372006-ae
    event group key
    EG000
    event group label
    Dose Finding - Level 0
    serious affected
    7
    serious at risk
    8
    other affected
    8
    other at risk
    8
    frequency threshold
    5
    collection period
    From the first drug administration until end of study, up to 336 days.
    event definition
    Treated set (TS) This patient set included all patients enrolled in the trial who were documented to have taken at least one dose of study medication.
    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-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    harm key
    EG001
    source section id
    NCT02372006-ae
    event group key
    EG001
    event group label
    Dose Finding - Level 1
    serious affected
    6
    serious at risk
    9
    other affected
    9
    other at risk
    9
    frequency threshold
    5
    collection period
    From the first drug administration until end of study, up to 336 days.
    event definition
    Treated set (TS) This patient set included all patients enrolled in the trial who were documented to have taken at least one dose of study medication.
    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-primitive-neuroectodermal-tumor
    nct id
    NCT02372006
    harm key
    EG002
    source section id
    NCT02372006-ae
    event group key
    EG002
    event group label
    Maximum Tolerated Dose (MTD) Expansion Cohort - Level 0
    serious affected
    20
    serious at risk
    39
    other affected
    38
    other at risk
    39
    frequency threshold
    5
    collection period
    From the first drug administration until end of study, up to 336 days.
    event definition
    Treated set (TS) This patient set included all patients enrolled in the trial who were documented to have taken at least one dose of study medication.
    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