Percentage of Participants With Adverse Events (AE) Related to Treatment
H3.3K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other Gliomas · Source last updated 2025-01-22
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
24 months
What was measured
Safety of the vaccine (Strata A and B) or vaccine in combination with nivolumab (Stratum C) will be assessed for participants who received the vaccination. The severity of toxicities will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE)version 5.0. and include any clinically-significant lab abnormalities meeting Grade 3, 4, or 5 criteria according to CTCAE. Grade 1 \& 2 AEs will be summarized if probably, possible, or definitely related to study therapy. Descriptive statistics will be utilized to display the data on toxicity reported by participants.
Groups in this outcome
Stratum A: Newly Diagnosed DIPG
Newly diagnosed children with diffuse intrinsic pontine glioma who are positive for HLA-A2 and the H3.3K27M mutation that underwent radiation therapy will receive the specific H3.3K27M peptide vaccine, combined with the tetanus toxoid (TT) peptide, emulsified in Montanide. Poly-ICLC, which is a synthetic nucleic acid, will be given concurrently to improve the therapeutic effects of the vaccine. Vaccine will be given every 3 weeks for the first 24 weeks, then if there is stable or improved disease, will be given every 6 weeks for a total treatment period of 96 weeks.
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
Newly diagnosed children with gliomas other than DIPG who are positive for HLA-A2 and the H3.3K27M mutation that underwent radiation therapy will receive the specific H3.3K27M peptide vaccine, combined with the tetanus toxoid peptide, emulsified in Montanide. Poly-ICLC, which is a synthetic nucleic acid, will be given concurrently to improve the therapeutic effects of the vaccine. Vaccine will be given every 3 weeks for the first 24 weeks, then if there is stable or improved disease, will be given every 6 weeks for a total treatment period of 96 weeks.
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
Newly diagnosed children with DIPG or other midline gliomas (excluding primary spinal cord tumors) who are positive for HLA-A2 (02:01) and the H3.3K27M mutation that underwent radiation therapy will receive the specific H3.3K27M peptide vaccine, combined with the tetanus toxoid peptide, emulsified in Montanide. Poly-ICLC, which is a synthetic nucleic acid, will be given concurrently to improve the therapeutic effects of the vaccine. Nivolumab will also be given via IV. Vaccine will be given every 3 weeks for the first 24 weeks, then if there is stable or improved disease, will be given every 6 weeks for a total treatment period of 96 weeks. Nivolumab will continue to be given every 3 weeks throughout all of treatment.
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
Stratum A: Newly Diagnosed DIPG
19
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
21
Reported measurements
Abdominal Pain
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Abducens Nerve Disorder
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
21.0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
9.5
Not reported
Not reported
Not reported
Not reported
Acoustic Nerve Disorder
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Adult respiratory distress syndrome
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Agitation
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
10.5
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Alanine aminotransferase increased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
42.1
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
20
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
28.6
Not reported
Not reported
Not reported
Not reported
Alkalosis
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Allergic Reaction
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Alopecia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
9.5
Not reported
Not reported
Not reported
Not reported
Anemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
15.8
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
14.3
Not reported
Not reported
Not reported
Not reported
Anorexia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
20
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
23.8
Not reported
Not reported
Not reported
Not reported
Arthralgia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
15.8
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Aspartate aminotransferase increased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
36.8
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
20
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
19
Not reported
Not reported
Not reported
Not reported
Aspiration
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Ataxia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
10.5
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Atelectasis
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Blood bicarbonate decreased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Blood bilirubin increased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Blurred Vision
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Bruising
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Cardiac troponin T increased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
9.5
Not reported
Not reported
Not reported
Not reported
Chills
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Constipation
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
14.3
Not reported
Not reported
Not reported
Not reported
CPK increased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Creatinine Increased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Depressed levels of consciousness
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Diarrhea
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
10.5
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Dizziness
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
14.3
Not reported
Not reported
Not reported
Not reported
Dry Skin
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Dysarthria
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
15.8
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
23.8
Not reported
Not reported
Not reported
Not reported
Dysphagia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
10.5
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
14.3
Not reported
Not reported
Not reported
Not reported
Dysphasia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
9.5
Not reported
Not reported
Not reported
Not reported
Dyspnea
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Edema Cerebral
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Encephalopathy
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Enterocolitis Infectious
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Eosinophilia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Epistaxis
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Extraocular muscle paresis
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Eye disorders - Other
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Facial Nerve Disorder
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
23.8
Not reported
Not reported
Not reported
Not reported
Fatigue
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
36.8
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
50
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
61.9
Not reported
Not reported
Not reported
Not reported
Fever
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
25.3
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
30
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
28.6
Not reported
Not reported
Not reported
Not reported
Flu like symptoms
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
40
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Gait Disturbance
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
15.8
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
General disorders and administration site conditions - Other
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Generalized Muscle Weakness
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
GGT Increased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Glossopharyngeal nerve disorder
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
14.3
Not reported
Not reported
Not reported
Not reported
Headache
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
47.3
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
30
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
38
Not reported
Not reported
Not reported
Not reported
Hearing Impaired
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Hiccups
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Hydrocephalus
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
14.3
Not reported
Not reported
Not reported
Not reported
Hyperglycemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Hypernatremia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Hypersomnia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Hypertension
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
14.3
Not reported
Not reported
Not reported
Not reported
Hyperthyroidism
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Hypoalbuminemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Hypocalcemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Hypoglycemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Hypokalemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
10.5
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
20
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
19
Not reported
Not reported
Not reported
Not reported
Hypomagnesemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Hyponatremia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
14.3
Not reported
Not reported
Not reported
Not reported
Hypophosphatemia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
14.3
Not reported
Not reported
Not reported
Not reported
Hypotension
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Hypoxia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Injection Site Reaction
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
68.4
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
50
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
38.1
Not reported
Not reported
Not reported
Not reported
International Normalized Ratio (INR) increased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Intracranial Hemorrhage
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Investigations - Other
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
10.5
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Keratitis
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Lethargy
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Leukocytosis
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Lipase Increased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
14.3
Not reported
Not reported
Not reported
Not reported
Lung Infection
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
10.5
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Lymphocyte count decreased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
31.5
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
60
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
28.6
Not reported
Not reported
Not reported
Not reported
Lymphocyte Count Increased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Meningitis
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Movements involuntary
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Muscle Weakness Left-Sided
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
21
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
19
Not reported
Not reported
Not reported
Not reported
Muscle Weakness Right-Sided
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
15.8
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
9.5
Not reported
Not reported
Not reported
Not reported
Musculoskeletal and connective tissue disorder - Other
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Myalgia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
15.8
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Myositis
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Nasal Congestion
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Nausea
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
21
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
19
Not reported
Not reported
Not reported
Not reported
Neck Pain
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
20
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Nervous system disorders - Other
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
10.5
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
23.8
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
15.8
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
19
Not reported
Not reported
Not reported
Not reported
Nystagmus
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
9.5
Not reported
Not reported
Not reported
Not reported
Oculomotor nerve disorder
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Optic Nerve Disorder
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Pain
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
19
Not reported
Not reported
Not reported
Not reported
Pain in extremity
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
10.5
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Paresthesia
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
14.3
Not reported
Not reported
Not reported
Not reported
Platelet Count Decreased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Pruritus
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
9.5
Not reported
Not reported
Not reported
Not reported
Pyramidal tract syndrome
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Rash maculo-papular
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Renal and urinary disorders - Other
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Respiratory failure
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Respiratory, thoracic and mediastinal disorders - Other
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
10.5
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Seizure
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
15.8
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Skin and subcutaneous tissue disorders - Other
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
10.5
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
9.5
Not reported
Not reported
Not reported
Not reported
Skin induration
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
2.63
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
14.3
Not reported
Not reported
Not reported
Not reported
Skin Infection
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Somnolence
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
10.5
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Spasticity
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Stomach Pain
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
10.5
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Stroke
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Thromboembolic event
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Thyroid stimulating hormone increased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Trigeminal Nerve Disorder
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Urinary Retention
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Urinary Tract Infection
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
0
Not reported
Not reported
Not reported
Not reported
Vaccination Complication
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
0
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
4.8
Not reported
Not reported
Not reported
Not reported
Vomiting
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
31.6
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
60
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
57.1
Not reported
Not reported
Not reported
Not reported
Weight Gain
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
0
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
9.5
Not reported
Not reported
Not reported
Not reported
Weight Loss
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
5.26
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
10
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
14.3
Not reported
Not reported
Not reported
Not reported
White blood cells decreased
Values in percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Stratum A: Newly Diagnosed DIPG
31.6
Not reported
Not reported
Not reported
Not reported
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
60
Not reported
Not reported
Not reported
Not reported
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
9.5
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
5.26
group Id
OG001
value
0
group Id
OG002
value
0
title
Abdominal Pain
categories
measurements
group Id
OG000
value
21.0
group Id
OG001
value
0
group Id
OG002
value
9.5
title
Abducens Nerve Disorder
categories
measurements
group Id
OG000
value
5.26
group Id
OG001
value
0
group Id
OG002
value
0
title
Acoustic Nerve Disorder
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
4.8
title
Adult respiratory distress syndrome
categories
measurements
group Id
OG000
value
10.5
group Id
OG001
value
0
group Id
OG002
value
0
title
Agitation
categories
measurements
group Id
OG000
value
42.1
group Id
OG001
value
20
group Id
OG002
value
28.6
title
Alanine aminotransferase increased
categories
measurements
group Id
OG000
value
5.26
group Id
OG001
value
0
group Id
OG002
value
0
title
Alkalosis
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
10
group Id
OG002
value
4.8
title
Allergic Reaction
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
9.5
title
Alopecia
categories
measurements
group Id
OG000
value
15.8
group Id
OG001
value
10
group Id
OG002
value
14.3
title
Anemia
categories
measurements
group Id
OG000
value
5.26
group Id
OG001
value
20
group Id
OG002
value
23.8
title
Anorexia
categories
measurements
group Id
OG000
value
15.8
group Id
OG001
value
0
group Id
OG002
value
0
title
Arthralgia
denoms
counts
group Id
OG000
value
19
group Id
OG001
value
10
group Id
OG002
value
21
units
Participants
description
Safety of the vaccine (Strata A and B) or vaccine in combination with nivolumab (Stratum C) will be assessed for participants who received the vaccination. The severity of toxicities will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE)version 5.0. and include any clinically-significant lab abnormalities meeting Grade 3, 4, or 5 criteria according to CTCAE. Grade 1 \& 2 AEs will be summarized if probably, possible, or definitely related to study therapy. Descriptive statistics will be utilized to display the data on toxicity reported by participants.
groups
description
Newly diagnosed children with diffuse intrinsic pontine glioma who are positive for HLA-A2 and the H3.3K27M mutation that underwent radiation therapy will receive the specific H3.3K27M peptide vaccine, combined with the tetanus toxoid (TT) peptide, emulsified in Montanide. Poly-ICLC, which is a synthetic nucleic acid, will be given concurrently to improve the therapeutic effects of the vaccine. Vaccine will be given every 3 weeks for the first 24 weeks, then if there is stable or improved disease, will be given every 6 weeks for a total treatment period of 96 weeks.
id
OG000
title
Stratum A: Newly Diagnosed DIPG
description
Newly diagnosed children with gliomas other than DIPG who are positive for HLA-A2 and the H3.3K27M mutation that underwent radiation therapy will receive the specific H3.3K27M peptide vaccine, combined with the tetanus toxoid peptide, emulsified in Montanide. Poly-ICLC, which is a synthetic nucleic acid, will be given concurrently to improve the therapeutic effects of the vaccine. Vaccine will be given every 3 weeks for the first 24 weeks, then if there is stable or improved disease, will be given every 6 weeks for a total treatment period of 96 weeks.
id
OG001
title
Stratum B: Newly Diagnosed Glioma (Non-DIPG)
description
Newly diagnosed children with DIPG or other midline gliomas (excluding primary spinal cord tumors) who are positive for HLA-A2 (02:01) and the H3.3K27M mutation that underwent radiation therapy will receive the specific H3.3K27M peptide vaccine, combined with the tetanus toxoid peptide, emulsified in Montanide. Poly-ICLC, which is a synthetic nucleic acid, will be given concurrently to improve the therapeutic effects of the vaccine. Nivolumab will also be given via IV. Vaccine will be given every 3 weeks for the first 24 weeks, then if there is stable or improved disease, will be given every 6 weeks for a total treatment period of 96 weeks. Nivolumab will continue to be given every 3 weeks throughout all of treatment.
id
OG002
title
Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
param Type
NUMBER
reporting Status
POSTED
time Frame
24 months
title
Percentage of Participants With Adverse Events (AE) Related to Treatment
Triangle