Trial Outcomes & Findings for HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed GBM (NCT NCT00905060)
NCT ID: NCT00905060
Last Updated: 2021-03-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2021-03-24
Participant Flow
Recruitment took place between June 29, 2009 and April 2012 for participants scheduled for gross total resection of recurrent Glioblastoma multiforme (GBM) across 8 sites
Participant milestones
| Measure |
Protein Peptide-Complex (HSPPC-96)
Patients will receive 4 weekly injections of HSPPC-96 followed by a 5th vaccine injection on the same day of the start of maintenance temozolomide administered 2 weeks (+ 4 days) following vaccine administration #4 on the same day of the start of maintenance temozolomide (Day 36). Monthly vaccine injections will then begin on day 21 (+/- 7 days) of the first 28 day temozolomide cycle (Day 56 of the study), 3 weeks following vaccine administration #5 and will continue every 28 days until depletion of vaccine or progression.
HSPPC-96: Autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide.
|
|---|---|
|
Surgical Resection
STARTED
|
70
|
|
Surgical Resection
COMPLETED
|
46
|
|
Surgical Resection
NOT COMPLETED
|
24
|
|
Vaccination Treatment Period
STARTED
|
46
|
|
Vaccination Treatment Period
COMPLETED
|
46
|
|
Vaccination Treatment Period
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only 46 participants were eligible to receive vaccination treatment
Baseline characteristics by cohort
| Measure |
Protein Peptide-Complex (HSPPC-96)
n=70 Participants
Patients will receive 4 weekly injections of HSPPC-96 followed by a 5th vaccine injection on the same day of the start of maintenance temozolomide administered 2 weeks (+ 4 days) following vaccine administration #4 on the same day of the start of maintenance temozolomide (Day 36). Monthly vaccine injections will then begin on day 21 (+/- 7 days) of the first 28 day temozolomide cycle (Day 56 of the study), 3 weeks following vaccine administration #5 and will continue every 28 days until depletion of vaccine or progression.
HSPPC-96: Autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide.
|
|---|---|
|
Age, Customized
30-39 years old
|
2 Participants
n=70 Participants
|
|
Age, Customized
40-49 years old
|
13 Participants
n=70 Participants
|
|
Age, Customized
50-59 years old
|
19 Participants
n=70 Participants
|
|
Age, Customized
60-69 years old
|
25 Participants
n=70 Participants
|
|
Age, Customized
70-79 years old
|
11 Participants
n=70 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=70 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=70 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=70 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=70 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=70 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=70 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=70 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=70 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=70 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=70 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=70 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=70 Participants
|
|
Median Number of Vaccination Doses Administered
|
9 vaccine injections
n=46 Participants • Only 46 participants were eligible to receive vaccination treatment
|
PRIMARY outcome
Timeframe: Up to 3 yearsOutcome measures
| Measure |
Protein Peptide-Complex (HSPPC-96)
n=46 Participants
Patients will receive 4 weekly injections of HSPPC-96 followed by a 5th vaccine injection on the same day of the start of maintenance temozolomide administered 2 weeks (+ 4 days) following vaccine administration #4 on the same day of the start of maintenance temozolomide (Day 36). Monthly vaccine injections will then begin on day 21 (+/- 7 days) of the first 28 day temozolomide cycle (Day 56 of the study), 3 weeks following vaccine administration #5 and will continue every 28 days until depletion of vaccine or progression.
HSPPC-96: Autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events of Any Grade
|
34 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsOverall survival is defined as the time from surgical resection to death of any cause.
Outcome measures
| Measure |
Protein Peptide-Complex (HSPPC-96)
n=46 Participants
Patients will receive 4 weekly injections of HSPPC-96 followed by a 5th vaccine injection on the same day of the start of maintenance temozolomide administered 2 weeks (+ 4 days) following vaccine administration #4 on the same day of the start of maintenance temozolomide (Day 36). Monthly vaccine injections will then begin on day 21 (+/- 7 days) of the first 28 day temozolomide cycle (Day 56 of the study), 3 weeks following vaccine administration #5 and will continue every 28 days until depletion of vaccine or progression.
HSPPC-96: Autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide.
|
|---|---|
|
Median Overall Survival
|
23.8 months
Interval 19.8 to 30.2
|
SECONDARY outcome
Timeframe: Up to 3 yearsPFS is defined as the duration of progression-free survival from the time from resection until either documented disease progression or death
Outcome measures
| Measure |
Protein Peptide-Complex (HSPPC-96)
n=46 Participants
Patients will receive 4 weekly injections of HSPPC-96 followed by a 5th vaccine injection on the same day of the start of maintenance temozolomide administered 2 weeks (+ 4 days) following vaccine administration #4 on the same day of the start of maintenance temozolomide (Day 36). Monthly vaccine injections will then begin on day 21 (+/- 7 days) of the first 28 day temozolomide cycle (Day 56 of the study), 3 weeks following vaccine administration #5 and will continue every 28 days until depletion of vaccine or progression.
HSPPC-96: Autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide.
|
|---|---|
|
Median Progression Free Survival (PFS)
|
18 months
Interval 12.4 to 21.8
|
SECONDARY outcome
Timeframe: Up to 53 WeeksPopulation: Peripheral blood was available for analysis from 32 vaccine-treated patients
Circulating myeloid cells (CD45+/CD11b+) obtained from patients at the time of surgery were analyzed for PD-L1 expression to determine the percent of myeloid cells positive for PD-L1 (cut off for positivity determined relative to Fluorescence Minus One (FMO) and isotype control).
Outcome measures
| Measure |
Protein Peptide-Complex (HSPPC-96)
n=32 Participants
Patients will receive 4 weekly injections of HSPPC-96 followed by a 5th vaccine injection on the same day of the start of maintenance temozolomide administered 2 weeks (+ 4 days) following vaccine administration #4 on the same day of the start of maintenance temozolomide (Day 36). Monthly vaccine injections will then begin on day 21 (+/- 7 days) of the first 28 day temozolomide cycle (Day 56 of the study), 3 weeks following vaccine administration #5 and will continue every 28 days until depletion of vaccine or progression.
HSPPC-96: Autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide.
|
|---|---|
|
Median PD-L1 Positivity in Circulating Myeloid Cells
|
54.5 percentage of PD-L1 positivity
Interval 5.9 to 91.8
|
Adverse Events
Protein Peptide-Complex (HSPPC-96)
Serious events: 10 serious events
Other events: 44 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Protein Peptide-Complex (HSPPC-96)
n=46 participants at risk
Patients will receive 4 weekly injections of HSPPC-96 followed by a 5th vaccine injection on the same day of the start of maintenance temozolomide administered 2 weeks (+ 4 days) following vaccine administration #4 on the same day of the start of maintenance temozolomide (Day 36). Monthly vaccine injections will then begin on day 21 (+/- 7 days) of the first 28 day temozolomide cycle (Day 56 of the study), 3 weeks following vaccine administration #5 and will continue every 28 days until depletion of vaccine or progression.
HSPPC-96: Autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide.
|
|---|---|
|
General disorders
Pain
|
2.2%
1/46 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Nervous system disorders
Seizure
|
6.5%
3/46 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Nervous system disorders
Syncope
|
2.2%
1/46 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Infections and infestations
Infections and infestations - Other
|
2.2%
1/46 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
2.2%
1/46 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Nervous system disorders
Cognitive disturbance
|
2.2%
1/46 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Nervous system disorders
Hydrocephalus
|
2.2%
1/46 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
2.2%
1/46 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
Other adverse events
| Measure |
Protein Peptide-Complex (HSPPC-96)
n=46 participants at risk
Patients will receive 4 weekly injections of HSPPC-96 followed by a 5th vaccine injection on the same day of the start of maintenance temozolomide administered 2 weeks (+ 4 days) following vaccine administration #4 on the same day of the start of maintenance temozolomide (Day 36). Monthly vaccine injections will then begin on day 21 (+/- 7 days) of the first 28 day temozolomide cycle (Day 56 of the study), 3 weeks following vaccine administration #5 and will continue every 28 days until depletion of vaccine or progression.
HSPPC-96: Autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide.
|
|---|---|
|
Nervous system disorders
Seizure
|
13.0%
6/46 • Number of events 7 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Nervous system disorders
Ataxia
|
8.7%
4/46 • Number of events 5 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Nervous system disorders
Peripheral motor neuropathy
|
8.7%
4/46 • Number of events 6 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Nervous system disorders
Headache
|
6.5%
3/46 • Number of events 5 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Nervous system disorders
Memory Impairment
|
6.5%
3/46 • Number of events 4 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Nervous system disorders
Nervous system disorders - Other
|
6.5%
3/46 • Number of events 4 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Nervous system disorders
Dysphasia
|
4.3%
2/46 • Number of events 2 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Nervous system disorders
Depressed level of consciousness
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Nervous system disorders
Dizziness
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Nervous system disorders
Facial nerve disorder
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.2%
1/46 • Number of events 2 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Nervous system disorders
Pyramidal tract syndrome
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Nervous system disorders
Tremor
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Investigations
Lymphocyte count decreased
|
15.2%
7/46 • Number of events 28 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Investigations
White blood cell decreased
|
8.7%
4/46 • Number of events 19 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Investigations
Platelet count decreased
|
6.5%
3/46 • Number of events 11 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Investigations
Alanine aminotransferase increased
|
4.3%
2/46 • Number of events 3 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Investigations
Alkaline phosphatase increased
|
2.2%
1/46 • Number of events 2 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Investigations
Aspartate aminotransferase increased
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Investigations
Blood bilirubin increased
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Investigations
CPK increased
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Investigations
Neutrophil count decreased
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
General disorders
Fatigue
|
13.0%
6/46 • Number of events 14 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
General disorders
Injection site reaction
|
34.8%
16/46 • Number of events 16 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
General disorders
Pain
|
4.3%
2/46 • Number of events 3 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
General disorders
Chills
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
General disorders
Edema limbs
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
General disorders
Fever
|
2.2%
1/46 • Number of events 3 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
General disorders
Gait disturbance
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.2%
7/46 • Number of events 11 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Metabolism and nutrition disorders
Anorexia
|
4.3%
2/46 • Number of events 2 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.3%
2/46 • Number of events 3 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.2%
1/46 • Number of events 3 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Blood and lymphatic system disorders
Anemia
|
13.0%
6/46 • Number of events 21 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Gastrointestinal disorders
Constipation
|
6.5%
3/46 • Number of events 3 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Gastrointestinal disorders
Nausea
|
6.5%
3/46 • Number of events 6 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Gastrointestinal disorders
Oral hemorrhage
|
4.3%
2/46 • Number of events 2 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
2/46 • Number of events 4 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Gastrointestinal disorders
Dental caries
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Gastrointestinal disorders
Mucositis oral
|
2.2%
1/46 • Number of events 2 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.3%
2/46 • Number of events 2 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Psychiatric disorders
Depression
|
4.3%
2/46 • Number of events 2 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Psychiatric disorders
Anxiety
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Psychiatric disorders
Insomnia
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Infections and infestations
Abdominal infection
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Infections and infestations
Upper respiratory infection
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Cardiac disorders
Acute coronary syndrome
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Eye disorders
Blurred vision
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Immune system disorders
Allergic reaction
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
2/46 • Number of events 2 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Vascular disorders
Flushing
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.5%
3/46 • Number of events 3 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
1/46 • Number of events 1 • Up to 3 years
Adverse events were reported for the participants who received at least one injection of the vaccine or one dose of temozolomide (TMZ)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place