Trial Outcomes & Findings for A Study of Varlilumab and IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG) (NCT NCT02924038)
NCT ID: NCT02924038
Last Updated: 2024-06-14
Results Overview
The proportion of participants experiencing and RLT defined as an adverse event judged to be possibly, probably or definitely associated with treatment that requires participants to be taken off study and no further injections will be given will be reported.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
up to 2 years
Results posted on
2024-06-14
Participant Flow
Participant milestones
| Measure |
IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV
IMA950 4.96mg and poly-ICLC 1.4mg administered as one formulation subcutaneously followed immediately by a Varlilumab 3mg/kg infusion (intravenously) -23±2 days (about 3 weeks) before the date of scheduled standard-of-care surgery to remove the World Health Organization (WHO) grade II glioma. Patients will continue receiving IMA950/poly-ICLC subcutaneous injections every week leading up to surgery (Days -16±2, -9±2 and 24-48 hours prior to scheduled surgery) and every 3 weeks after surgery (Weeks A1, A4, A7, A10, A13, A16, A19, A22; defining Week A1 as the first post-surgery vaccine). After surgery, patients will continue receiving a Varlilumab infusion every 6 weeks immediately following the IMA950/poly-ICLC injection (Weeks A1, A7, A13, and A19).
|
IMA950/Poly-ICLC subQ Only
IMA950 4.96mg and poly-ICLC 1.4mg administered as one formulation subcutaneously every week leading up to standard-of-care surgery to remove the WHO grade II glioma (Days -23±2, -16±2, -9±2 and 24-48 hours prior to scheduled surgery) and every three weeks after surgery (Weeks A1, A4, A7, A10, A13, A16, A19, A22; defining Week A1 as the first post-surgery vaccine). Patients will not receive Varlilumab.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
|
Overall Study
Included in Biological Analysis
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV
IMA950 4.96mg and poly-ICLC 1.4mg administered as one formulation subcutaneously followed immediately by a Varlilumab 3mg/kg infusion (intravenously) -23±2 days (about 3 weeks) before the date of scheduled standard-of-care surgery to remove the World Health Organization (WHO) grade II glioma. Patients will continue receiving IMA950/poly-ICLC subcutaneous injections every week leading up to surgery (Days -16±2, -9±2 and 24-48 hours prior to scheduled surgery) and every 3 weeks after surgery (Weeks A1, A4, A7, A10, A13, A16, A19, A22; defining Week A1 as the first post-surgery vaccine). After surgery, patients will continue receiving a Varlilumab infusion every 6 weeks immediately following the IMA950/poly-ICLC injection (Weeks A1, A7, A13, and A19).
|
IMA950/Poly-ICLC subQ Only
IMA950 4.96mg and poly-ICLC 1.4mg administered as one formulation subcutaneously every week leading up to standard-of-care surgery to remove the WHO grade II glioma (Days -23±2, -16±2, -9±2 and 24-48 hours prior to scheduled surgery) and every three weeks after surgery (Weeks A1, A4, A7, A10, A13, A16, A19, A22; defining Week A1 as the first post-surgery vaccine). Patients will not receive Varlilumab.
|
|---|---|---|
|
Overall Study
Excluded from post-surgery vaccines due to high-grade diagnosis of resected tumor
|
2
|
2
|
Baseline Characteristics
A Study of Varlilumab and IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG)
Baseline characteristics by cohort
| Measure |
IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV
n=8 Participants
IMA950 4.96mg and poly-ICLC 1.4mg administered as one formulation subcutaneously followed immediately by a Varlilumab 3mg/kg infusion (intravenously) -23±2 days (about 3 weeks) before the date of scheduled standard-of-care surgery to remove the WHO grade II glioma. Patients will continue receiving IMA950/poly-ICLC subcutaneous injections every week leading up to surgery (Days -16±2, -9±2 and 24-48 hours prior to scheduled surgery) and every 3 weeks after surgery (Weeks A1, A4, A7, A10, A13, A16, A19, A22; defining Week A1 as the first post-surgery vaccine). After surgery, patients will continue receiving a Varlilumab infusion every 6 weeks immediately following the IMA950/poly-ICLC injection (Weeks A1, A7, A13, and A19).
|
IMA950/Poly-ICLC subQ Only
n=6 Participants
IMA950 4.96mg and poly-ICLC 1.4mg administered as one formulation subcutaneously every week leading up to standard-of-care surgery to remove the WHO grade II glioma (Days -23±2, -16±2, -9±2 and 24-48 hours prior to scheduled surgery) and every three weeks after surgery (Weeks A1, A4, A7, A10, A13, A16, A19, A22; defining Week A1 as the first post-surgery vaccine). Patients will not receive Varlilumab.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
20-29 years old
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Customized
30-39 years old
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
40-49 years old
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Customized
50-59 years old
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 2 yearsThe proportion of participants experiencing and RLT defined as an adverse event judged to be possibly, probably or definitely associated with treatment that requires participants to be taken off study and no further injections will be given will be reported.
Outcome measures
| Measure |
IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV
n=8 Participants
IMA950 4.96mg and poly-ICLC 1.4mg administered as one formulation subcutaneously followed immediately by a Varlilumab 3mg/kg infusion (intravenously) -23±2 days (about 3 weeks) before the date of scheduled standard-of-care surgery to remove the WHO grade II glioma. Patients will continue receiving IMA950/poly-ICLC subcutaneous injections every week leading up to surgery (Days -16±2, -9±2 and 24-48 hours prior to scheduled surgery) and every 3 weeks after surgery (Weeks A1, A4, A7, A10, A13, A16, A19, A22; defining Week A1 as the first post-surgery vaccine). After surgery, patients will continue receiving a Varlilumab infusion every 6 weeks immediately following the IMA950/poly-ICLC injection (Weeks A1, A7, A13, and A19).
|
IMA950/Poly-ICLC subQ Only
n=6 Participants
IMA950 4.96mg and poly-ICLC 1.4mg administered as one formulation subcutaneously every week leading up to standard-of-care surgery to remove the WHO grade II glioma (Days -23±2, -16±2, -9±2 and 24-48 hours prior to scheduled surgery) and every three weeks after surgery (Weeks A1, A4, A7, A10, A13, A16, A19, A22; defining Week A1 as the first post-surgery vaccine). Patients will not receive Varlilumab.
|
|---|---|---|
|
Proportion of Participants Experiencing Regimen Limiting Toxicity (RLT)
|
0 proportion of participants
|
0 proportion of participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsThe expansion of IMA950-reactive CD8+ T cell frequencies over post-vaccine periods was assessed by calculating the mean percentage of total IMA950 tetramer-positive CD8+ T cell per available post-vaccine time point. CD8+ T-cell response to the IMA950-epitope is defined to be positive when the percentage of tetramer-positive CD8+ T cells showed a four-fold or higher increase within at least one-time point in the post-vaccine phase relative to the corresponding percentage at the pre-vaccine.
Outcome measures
| Measure |
IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV
n=6 Participants
IMA950 4.96mg and poly-ICLC 1.4mg administered as one formulation subcutaneously followed immediately by a Varlilumab 3mg/kg infusion (intravenously) -23±2 days (about 3 weeks) before the date of scheduled standard-of-care surgery to remove the WHO grade II glioma. Patients will continue receiving IMA950/poly-ICLC subcutaneous injections every week leading up to surgery (Days -16±2, -9±2 and 24-48 hours prior to scheduled surgery) and every 3 weeks after surgery (Weeks A1, A4, A7, A10, A13, A16, A19, A22; defining Week A1 as the first post-surgery vaccine). After surgery, patients will continue receiving a Varlilumab infusion every 6 weeks immediately following the IMA950/poly-ICLC injection (Weeks A1, A7, A13, and A19).
|
IMA950/Poly-ICLC subQ Only
n=5 Participants
IMA950 4.96mg and poly-ICLC 1.4mg administered as one formulation subcutaneously every week leading up to standard-of-care surgery to remove the WHO grade II glioma (Days -23±2, -16±2, -9±2 and 24-48 hours prior to scheduled surgery) and every three weeks after surgery (Weeks A1, A4, A7, A10, A13, A16, A19, A22; defining Week A1 as the first post-surgery vaccine). Patients will not receive Varlilumab.
|
|---|---|---|
|
Mean Percentage of CD8+ T-cell Responses in Pre- and Post-vaccine Peripheral Blood Mononuclear Cells (PBMC)
Pre-Vaccine Cluster 3 Effector CD8
|
4.5 percentage of T cell responses
Standard Deviation 4.2
|
7.3 percentage of T cell responses
Standard Deviation 3.6
|
|
Mean Percentage of CD8+ T-cell Responses in Pre- and Post-vaccine Peripheral Blood Mononuclear Cells (PBMC)
Post-Vaccine Cluster 3 Effector CD8
|
12.5 percentage of T cell responses
Standard Deviation 8.0
|
13.3 percentage of T cell responses
Standard Deviation 8.3
|
|
Mean Percentage of CD8+ T-cell Responses in Pre- and Post-vaccine Peripheral Blood Mononuclear Cells (PBMC)
Pre-vaccine Cluster 8 Effector memory
|
2.2 percentage of T cell responses
Standard Deviation 1.0
|
2.7 percentage of T cell responses
Standard Deviation 2.2
|
|
Mean Percentage of CD8+ T-cell Responses in Pre- and Post-vaccine Peripheral Blood Mononuclear Cells (PBMC)
Post-vaccine Cluster 8 Effector memory
|
5.9 percentage of T cell responses
Standard Deviation 2.3
|
4.5 percentage of T cell responses
Standard Deviation 4.6
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Data not collected.
The expansion of IMA950-reactive CD4+ T cell frequencies over post-vaccine periods was assessed by calculating the mean percentage of total IMA950 tetramer-positive CD4+ T cell per available post-vaccine time point. CD4+ T-cell response to the IMA950-epitope is defined to be positive when the percentage of tetramer-positive CD4+ T cells showed a four-fold or higher increase within at least one-time point in the post-vaccine phase relative to the corresponding percentage at the pre-vaccine.
Outcome measures
Outcome data not reported
Adverse Events
IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV
Serious events: 1 serious events
Other events: 8 other events
Deaths: 1 deaths
IMA950/Poly-ICLC subQ Only
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV
n=8 participants at risk
IMA950 4.96mg and poly-ICLC 1.4mg administered as one formulation subcutaneously followed immediately by a Varlilumab 3mg/kg infusion (intravenously) -23±2 days (about 3 weeks) before the date of scheduled standard-of-care surgery to remove the WHO grade II glioma. Patients will continue receiving IMA950/poly-ICLC subcutaneous injections every week leading up to surgery (Days -16±2, -9±2 and 24-48 hours prior to scheduled surgery) and every 3 weeks after surgery (Weeks A1, A4, A7, A10, A13, A16, A19, A22; defining Week A1 as the first post-surgery vaccine). After surgery, patients will continue receiving a Varlilumab infusion every 6 weeks immediately following the IMA950/poly-ICLC injection (Weeks A1, A7, A13, and A19).
|
IMA950/Poly-ICLC subQ Only
n=6 participants at risk
IMA950 4.96mg and poly-ICLC 1.4mg administered as one formulation subcutaneously every week leading up to standard-of-care surgery to remove the WHO grade II glioma (Days -23±2, -16±2, -9±2 and 24-48 hours prior to scheduled surgery) and every three weeks after surgery (Weeks A1, A4, A7, A10, A13, A16, A19, A22; defining Week A1 as the first post-surgery vaccine). Patients will not receive Varlilumab.
|
|---|---|---|
|
Nervous system disorders
Seizure
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
Other adverse events
| Measure |
IMA950/Poly-ICLC Subcutaneous (subQ) + Varlilumab IV
n=8 participants at risk
IMA950 4.96mg and poly-ICLC 1.4mg administered as one formulation subcutaneously followed immediately by a Varlilumab 3mg/kg infusion (intravenously) -23±2 days (about 3 weeks) before the date of scheduled standard-of-care surgery to remove the WHO grade II glioma. Patients will continue receiving IMA950/poly-ICLC subcutaneous injections every week leading up to surgery (Days -16±2, -9±2 and 24-48 hours prior to scheduled surgery) and every 3 weeks after surgery (Weeks A1, A4, A7, A10, A13, A16, A19, A22; defining Week A1 as the first post-surgery vaccine). After surgery, patients will continue receiving a Varlilumab infusion every 6 weeks immediately following the IMA950/poly-ICLC injection (Weeks A1, A7, A13, and A19).
|
IMA950/Poly-ICLC subQ Only
n=6 participants at risk
IMA950 4.96mg and poly-ICLC 1.4mg administered as one formulation subcutaneously every week leading up to standard-of-care surgery to remove the WHO grade II glioma (Days -23±2, -16±2, -9±2 and 24-48 hours prior to scheduled surgery) and every three weeks after surgery (Weeks A1, A4, A7, A10, A13, A16, A19, A22; defining Week A1 as the first post-surgery vaccine). Patients will not receive Varlilumab.
|
|---|---|---|
|
General disorders
Injection site reaction
|
100.0%
8/8 • Number of events 135 • Up to 2 years
|
100.0%
6/6 • Number of events 56 • Up to 2 years
|
|
General disorders
Fatigue
|
50.0%
4/8 • Number of events 7 • Up to 2 years
|
100.0%
6/6 • Number of events 26 • Up to 2 years
|
|
General disorders
Flu like symptoms
|
50.0%
4/8 • Number of events 36 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
|
General disorders
Fever
|
12.5%
1/8 • Number of events 4 • Up to 2 years
|
50.0%
3/6 • Number of events 3 • Up to 2 years
|
|
General disorders
Pain
|
25.0%
2/8 • Number of events 3 • Up to 2 years
|
16.7%
1/6 • Number of events 2 • Up to 2 years
|
|
General disorders
Chills
|
0.00%
0/8 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
General disorders
Edema face
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/8 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
62.5%
5/8 • Number of events 6 • Up to 2 years
|
33.3%
2/6 • Number of events 3 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
37.5%
3/8 • Number of events 4 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
25.0%
2/8 • Number of events 2 • Up to 2 years
|
33.3%
2/6 • Number of events 3 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
1/8 • Number of events 2 • Up to 2 years
|
33.3%
2/6 • Number of events 4 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
2/8 • Number of events 3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
12.5%
1/8 • Number of events 3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Nervous system disorders
Headache
|
62.5%
5/8 • Number of events 12 • Up to 2 years
|
66.7%
4/6 • Number of events 22 • Up to 2 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
50.0%
4/8 • Number of events 5 • Up to 2 years
|
50.0%
3/6 • Number of events 4 • Up to 2 years
|
|
Nervous system disorders
Seizure
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
50.0%
3/6 • Number of events 4 • Up to 2 years
|
|
Nervous system disorders
Memory impairment
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Paresthesia
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Ataxia
|
12.5%
1/8 • Number of events 2 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 2 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Nervous system disorders
Dysarthria
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Nervous system disorders
Dysphasia
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Nervous system disorders
Facial muscle weakness
|
12.5%
1/8 • Number of events 2 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Nervous system disorders
Presyncope
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Nervous system disorders
Tremor
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
6/8 • Number of events 7 • Up to 2 years
|
33.3%
2/6 • Number of events 8 • Up to 2 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
50.0%
4/8 • Number of events 5 • Up to 2 years
|
16.7%
1/6 • Number of events 2 • Up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
75.0%
6/8 • Number of events 24 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
37.5%
3/8 • Number of events 4 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Investigations
Neutrophil count decreased
|
25.0%
2/8 • Number of events 4 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Investigations
White blood cell decreased
|
37.5%
3/8 • Number of events 14 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 2 • Up to 2 years
|
|
Investigations
Blood bilirubin increased
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Investigations
CD4 lymphocytes decreased
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Investigations
Platelet count decreased
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Investigations
Weight loss
|
0.00%
0/8 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
37.5%
3/8 • Number of events 13 • Up to 2 years
|
50.0%
3/6 • Number of events 9 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • Number of events 5 • Up to 2 years
|
16.7%
1/6 • Number of events 7 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
25.0%
2/8 • Number of events 2 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/8 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Gastrointestinal disorders
Oral pain
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
37.5%
3/8 • Number of events 6 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
2/8 • Number of events 6 • Up to 2 years
|
16.7%
1/6 • Number of events 2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.5%
1/8 • Number of events 3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Psychiatric disorders
Insomnia
|
37.5%
3/8 • Number of events 7 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Psychiatric disorders
Agitation
|
0.00%
0/8 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
25.0%
2/8 • Number of events 2 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/8 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Eye disorders
Eye pain
|
37.5%
3/8 • Number of events 8 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Eye disorders
Photophobia
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Eye disorders
Blurred vision
|
12.5%
1/8 • Number of events 2 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Eye disorders
Retinal vascular disorder
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
25.0%
2/8 • Number of events 2 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Number of events 3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/8 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8 • Number of events 2 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • Up to 2 years
|
16.7%
1/6 • Number of events 4 • Up to 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Renal and urinary disorders
Urinary urgency
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/8 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
12.5%
1/8 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
Additional Information
Dr. Nicholas Butowski, MD
University of California, San Francisco
Phone: 415-353-7500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place