NCT03257631 · OUTCOME
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
A Study of Pomalidomide Monotherapy for Children and Young Adults With Recurrent or Progressive Primary Brain Tumors · Source last updated 2024-04-16
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From the first dose of pomalidomide until 28 days after the last dose (Up to approximately 72 months)
What was measured
Treatment-emergent adverse events were defined as any adverse events (AE) occurring from the first dose of pomalidomide until 28 days after the last dose. The severity of each AE was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 and according to the following scale: Grade 1: Mild (transient or mild discomfort; no limitation in activity or medical intervention required); Grade 2: Moderate (mild to moderate limitation in activity, assistance may be needed; minimal medical intervention required); Grade 3: Severe (marked limitation in activity, assistance and medical intervention required, hospitalization possible); Grade 4: Life-threatening (extreme limitation in activity, significant assistance or medical intervention required, hospitalization or hospice care probable); Grade 5: Death. Drug-related AEs are those suspected by the Investigator as being related to administration of study drug.
Analysis population: The safety population included all participants who received at least 1 dose of study drug
Groups in this outcome
Diffuse Intrinsic Pontine Glioma
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.
Ependymoma
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.
High-grade Glioma
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.
Medulloblastoma
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.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Diffuse Intrinsic Pontine Glioma | 11 |
|---|
| Ependymoma | 9 |
|---|
| High-grade Glioma | 22 |
|---|
| Medulloblastoma | 10 |
|---|
Reported measurements
Any treatment-emergent adverse event (TEAE)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Diffuse Intrinsic Pontine Glioma | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Ependymoma | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| High-grade Glioma | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
| Medulloblastoma | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAE related to study drug
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Diffuse Intrinsic Pontine Glioma | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Ependymoma | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| High-grade Glioma | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Medulloblastoma | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Diffuse Intrinsic Pontine Glioma | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Ependymoma | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| High-grade Glioma | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Medulloblastoma | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious TEAE related to study drug
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Diffuse Intrinsic Pontine Glioma | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Ependymoma | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| High-grade Glioma | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Medulloblastoma | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3/4 TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Diffuse Intrinsic Pontine Glioma | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Ependymoma | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| High-grade Glioma | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Medulloblastoma | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3/4 TEAE related to study drug
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Diffuse Intrinsic Pontine Glioma | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Ependymoma | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| High-grade Glioma | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Medulloblastoma | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAE leading to death
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Diffuse Intrinsic Pontine Glioma | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Ependymoma | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| High-grade Glioma | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Medulloblastoma | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAE leading to dose reduction
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Diffuse Intrinsic Pontine Glioma | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Ependymoma | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| High-grade Glioma | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Medulloblastoma | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAE leading to dose interruption
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Diffuse Intrinsic Pontine Glioma | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Ependymoma | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| High-grade Glioma | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Medulloblastoma | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAE leading to study drug discontinuation
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Diffuse Intrinsic Pontine Glioma | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Ependymoma | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| High-grade Glioma | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Medulloblastoma | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 9
- title
- Any treatment-emergent adverse event (TEAE)
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 8
- title
- TEAE related to study drug
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 4
- title
- Serious TEAE
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 0
- title
- Serious TEAE related to study drug
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 6
- title
- Grade 3/4 TEAE
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 4
- title
- Grade 3/4 TEAE related to study drug
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- title
- TEAE leading to death
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- title
- TEAE leading to dose reduction
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 2
- title
- TEAE leading to dose interruption
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- title
- TEAE leading to study drug discontinuation
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 10
- units
- Participants
- description
- Treatment-emergent adverse events were defined as any adverse events (AE) occurring from the first dose of pomalidomide until 28 days after the last dose. The severity of each AE was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 and according to the following scale: Grade 1: Mild (transient or mild discomfort; no limitation in activity or medical intervention required); Grade 2: Moderate (mild to moderate limitation in activity, assistance may be needed; minimal medical intervention required); Grade 3: Severe (marked limitation in activity, assistance and medical intervention required, hospitalization possible); Grade 4: Life-threatening (extreme limitation in activity, significant assistance or medical intervention required, hospitalization or hospice care probable); Grade 5: Death. Drug-related AEs are those suspected by the Investigator as being related to administration of study drug.
- groups
- description
- 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.
- id
- OG000
- title
- Diffuse Intrinsic Pontine Glioma
- description
- 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.
- id
- OG001
- title
- Ependymoma
- description
- 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.
- id
- OG002
- title
- High-grade Glioma
- description
- 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.
- id
- OG003
- title
- Medulloblastoma
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety population included all participants who received at least 1 dose of study drug
- reporting Status
- POSTED
- time Frame
- From the first dose of pomalidomide until 28 days after the last dose (Up to approximately 72 months)
- title
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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