Trial Outcomes & Findings for DC Migration Study for Newly-Diagnosed GBM (NCT NCT02366728)

Last Updated: 2023-06-08

Results Overview

Overall survival will be defined as the time in months between randomization and death, or last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

64 participants

Primary outcome timeframe

Up to 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)

Results posted on

2023-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Group I: Unpulsed DC Pre-conditioning 0.4 mLs of 1 x 10\^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group II: Tetanus Pre-conditioning Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group III: Basiliximab and Tetanus Pre-conditioning Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
Overall Study STARTED	27	28	9
Overall Study Received at Least One ppp65 Vaccine	25	27	8
Overall Study COMPLETED	23	27	8
Overall Study NOT COMPLETED	4	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group I: Unpulsed DC Pre-conditioning 0.4 mLs of 1 x 10\^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group II: Tetanus Pre-conditioning Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group III: Basiliximab and Tetanus Pre-conditioning Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
Overall Study Death	0	0	1
Overall Study Adverse Event	1	0	0
Overall Study Screen Failure	2	1	0
Overall Study Only yielded 2 vaccines	1	0	0

Baseline Characteristics

DC Migration Study for Newly-Diagnosed GBM

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group I: Unpulsed DC Pre-conditioning n=25 Participants 0.4 mLs of 1 x 10\^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group II: Tetanus Pre-conditioning n=27 Participants Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group III: Basiliximab and Tetanus Pre-conditioning n=8 Participants Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.	Total n=60 Participants Total of all reporting groups
Age, Continuous	55.7 years STANDARD_DEVIATION 13.3 • n=93 Participants	53.7 years STANDARD_DEVIATION 13.6 • n=4 Participants	50.4 years STANDARD_DEVIATION 12.4 • n=27 Participants	54.1 years STANDARD_DEVIATION 13.2 • n=483 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	10 Participants n=4 Participants	2 Participants n=27 Participants	18 Participants n=483 Participants
Sex: Female, Male Male	19 Participants n=93 Participants	17 Participants n=4 Participants	6 Participants n=27 Participants	42 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=93 Participants	25 Participants n=4 Participants	7 Participants n=27 Participants	54 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	5 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) White	23 Participants n=93 Participants	25 Participants n=4 Participants	8 Participants n=27 Participants	56 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
Region of Enrollment United States	25 Participants n=93 Participants	27 Participants n=4 Participants	8 Participants n=27 Participants	60 Participants n=483 Participants

PRIMARY outcome

Timeframe: Up to 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)

Overall survival will be defined as the time in months between randomization and death, or last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.

Outcome measures

Outcome measures
Measure	Group I: Unpulsed DC Pre-conditioning n=25 Participants 0.4 mLs of 1 x 10\^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group II: Tetanus Pre-conditioning n=27 Participants Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group III: Basiliximab and Tetanus Pre-conditioning n=8 Participants Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
Median Overall Survival	16 months Interval 12.8 to 25.5	20 months Interval 16.7 to 25.6	19 months Interval 10.26 to An estimation was not possible due to an insufficient number of participants experiencing events.

PRIMARY outcome

Timeframe: For each patient, migration studies will occur after vaccination #4 which occurs approximately 7 months after study consent.

Population: Data not collected on the Basiliximab and Tetanus pre-conditioning group.

Within Groups I and II only, the percentage of 111In-labeled DCs migrating to the inguinal lymph nodes from the initial injection sites in the left and right groin at 48 hours post-vaccination #4 will be calculated.

Outcome measures

Outcome measures
Measure	Group I: Unpulsed DC Pre-conditioning n=25 Participants 0.4 mLs of 1 x 10\^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group II: Tetanus Pre-conditioning n=27 Participants Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group III: Basiliximab and Tetanus Pre-conditioning Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
Percentage of 111In-labeled Dendritic Cells Migrating to the Inguinal Lymph Nodes	6.0 percentage of cells Interval 3.0 to 8.0	9 percentage of cells Interval 6.5 to 11.0	—

PRIMARY outcome

Timeframe: Up to 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)

Population: Participants who are CMV positive. Data not collected on the Basiliximab and Tetanus pre-conditioning group.

Median overall survival will be estimated in the subset of participants that are CMV positive. Overall survival will be defined as the time in months between randomization and death, or last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.

Outcome measures

Outcome measures
Measure	Group I: Unpulsed DC Pre-conditioning n=9 Participants 0.4 mLs of 1 x 10\^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group II: Tetanus Pre-conditioning n=11 Participants Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group III: Basiliximab and Tetanus Pre-conditioning Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
Median Overall Survival in CMV Positive Participants	16.5 months Interval 12.8 to 44.1	23.8 months Interval 19.9 to An estimation was not possible due to an insufficient number of participants experiencing events.	—

PRIMARY outcome

Timeframe: Up to 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)

Population: Participants who are CMV negative. Data not collected on the Basiliximab and Tetanus pre-conditioning group.

Median overall survival will be estimated in the subset of participants that are CMV negative. Overall survival will be defined as the time in months between randomization and death, or last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.

Outcome measures

Outcome measures
Measure	Group I: Unpulsed DC Pre-conditioning n=16 Participants 0.4 mLs of 1 x 10\^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group II: Tetanus Pre-conditioning n=16 Participants Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group III: Basiliximab and Tetanus Pre-conditioning Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
Median Overall Survival in CMV Negative Participants	13.4 months Interval 9.5 to 26.1	16.7 months Interval 13.6 to 45.6	—

SECONDARY outcome

Timeframe: Up to 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)

Progression-free survival will be defined as the time in months between randomization and disease progression or death. Participants alive without disease progression will be censored at the time of their last follow-up. Kaplan-Meier methods will be used to estimate progression-free survival.

Outcome measures

Outcome measures
Measure	Group I: Unpulsed DC Pre-conditioning n=25 Participants 0.4 mLs of 1 x 10\^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group II: Tetanus Pre-conditioning n=27 Participants Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group III: Basiliximab and Tetanus Pre-conditioning n=8 Participants Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
Median Progression-free Survival	6.5 months Interval 4.4 to 12.1	6.7 months Interval 4.6 to 15.2	7.1 months Interval 6.0 to An estimation was not possible due to an insufficient number of participants experiencing events.

SECONDARY outcome

Timeframe: Up to 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)

Population: Participants who are CMV positive. Data not collected on the Basiliximab and Tetanus pre-conditioning group.

Median progression-free survival will be estimated in the subset of participants that are CMV positive. Progression-free survival will be defined as the time in months between randomization and disease progression or death. Participants alive without disease progression will be censored at the time of their last follow-up. Kaplan-Meier methods will be used to estimate progression-free survival.

Outcome measures

Outcome measures
Measure	Group I: Unpulsed DC Pre-conditioning n=9 Participants 0.4 mLs of 1 x 10\^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group II: Tetanus Pre-conditioning n=11 Participants Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group III: Basiliximab and Tetanus Pre-conditioning Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
Median Progression-free Survival in CMV Positive Participants	6.5 months Interval 4.4 to An estimation was not possible due to an insufficient number of participants experiencing events.	6.8 months Interval 6.5 to An estimation was not possible due to an insufficient number of participants experiencing events.	—

SECONDARY outcome

Timeframe: Up to 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)

Population: Participants who are CMV negative. Data not collected on the Basiliximab and Tetanus pre-conditioning group.

Median progression-free survival will be estimated in the subset of participants that are CMV negative. Progression-free survival will be defined as the time in months between randomization and disease progression or death. Participants alive without disease progression will be censored at the time of their last follow-up. Kaplan-Meier methods will be used to estimate progression-free survival.

Outcome measures

Outcome measures
Measure	Group I: Unpulsed DC Pre-conditioning n=16 Participants 0.4 mLs of 1 x 10\^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group II: Tetanus Pre-conditioning n=16 Participants Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group III: Basiliximab and Tetanus Pre-conditioning Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
Median Progression-free Survival in CMV Negative Participants	5.9 months Interval 4.1 to 14.7	5.8 months Interval 4.1 to 24.4	—

Adverse Events

Group I: Unpulsed DC Pre-conditioning

Serious events: 1 serious events

Other events: 25 other events

Deaths: 24 deaths

Group II: Tetanus Pre-conditioning

Serious events: 4 serious events

Other events: 27 other events

Deaths: 22 deaths

Group III: Basiliximab and Tetanus Pre-conditioning

Serious events: 2 serious events

Other events: 9 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Group I: Unpulsed DC Pre-conditioning n=27 participants at risk 0.4 mLs of 1 x 10\^6 autologous unpulsed DCs in saline will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group II: Tetanus Pre-conditioning n=28 participants at risk Tetanus diptheria toxoid (Td) (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine. pp65 DC Vaccine #4 is 111In-labeled DCs for migration studies.	Group III: Basiliximab and Tetanus Pre-conditioning n=9 participants at risk Basiliximab infusions prior to human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccines #1 and #2 with Td pre-conditioning (1 flocculation unit) will be administered to a single side of the groin, and 0.4 mLs of saline administered to the contralateral side 1 day prior to the 4th human CMV pp65-LAMP mRNA-pulsed autologous DCs vaccine.
Gastrointestinal disorders Colonic perforation	0.00% 0/27 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	0.00% 0/28 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	11.1% 1/9 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)
Infections and infestations Lung infection	3.7% 1/27 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	0.00% 0/28 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	0.00% 0/9 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)
Infections and infestations Urinary tract infection	0.00% 0/27 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	3.6% 1/28 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	0.00% 0/9 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/27 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	3.6% 1/28 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	11.1% 1/9 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	0.00% 0/27 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	0.00% 0/28 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	11.1% 1/9 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)
Nervous system disorders Dysphasia	0.00% 0/27 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	3.6% 1/28 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	0.00% 0/9 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)
Nervous system disorders Headache	0.00% 0/27 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	3.6% 1/28 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	0.00% 0/9 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)
Nervous system disorders Pyramidal tract syndrome	0.00% 0/27 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	3.6% 1/28 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	11.1% 1/9 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)
Nervous system disorders Seizure	0.00% 0/27 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	7.1% 2/28 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	0.00% 0/9 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)
Psychiatric disorders Delirium	0.00% 0/27 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	3.6% 1/28 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)	0.00% 0/9 • Approximately 72 months (from the time of randomization of the first patient until approximately 31 months after randomization of the last patient)

Other adverse events

Additional Information

Mustafa Khasraw, M.D.

Duke University

Phone: 919-668-6688

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place