Trial Outcomes & Findings for Trial of C134 in Patients With Recurrent GBM (NCT NCT03657576)
NCT ID: NCT03657576
Last Updated: 2025-08-03
Results Overview
Dose modifications will utilize a modified Continual Reassessment Method (CRM) for each successive subject until an MTD or the maximal planned dose is reached.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
from baseline through month 12
Results posted on
2025-08-03
Participant Flow
Participant milestones
| Measure |
10^6 Single Dose of C134
Participants were administered 10\^6 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^7 Single Dose of C134
Participants were administered 10\^7 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^7.5 Single Dose of C134
Participants were administered 10\^7.5 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^5 Single Dose of C134
Participants were administered 10\^5 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^5.5 Single Dose of C134
Participants were administered 10\^5.5 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
Screen Fails
Participants that consented to the study, but ended up becoming ineligible before they were given C134
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
1
|
8
|
1
|
5
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
7
|
0
|
5
|
Reasons for withdrawal
| Measure |
10^6 Single Dose of C134
Participants were administered 10\^6 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^7 Single Dose of C134
Participants were administered 10\^7 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^7.5 Single Dose of C134
Participants were administered 10\^7.5 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^5 Single Dose of C134
Participants were administered 10\^5 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^5.5 Single Dose of C134
Participants were administered 10\^5.5 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
Screen Fails
Participants that consented to the study, but ended up becoming ineligible before they were given C134
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Screen Fail
|
0
|
0
|
0
|
0
|
0
|
5
|
|
Overall Study
Disease Progression
|
1
|
1
|
0
|
5
|
0
|
0
|
|
Overall Study
Insurance Coverage
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Trial of C134 in Patients With Recurrent GBM
Baseline characteristics by cohort
| Measure |
10^6 Single Dose of C134
n=2 Participants
Participants were administered 10\^6 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^7 Single Dose of C134
n=2 Participants
Participants were administered 10\^7 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^7.5 Single Dose of C134
n=1 Participants
Participants were administered 10\^7.5 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^5 Single Dose of C134
n=8 Participants
Participants were administered 10\^5 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^5.5 Single Dose of C134
n=1 Participants
Participants were administered 10\^5.5 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
Screen Fails
n=5 Participants
Participants that consented to the study, but ended up becoming ineligible before they were given C134
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: from baseline through month 12Dose modifications will utilize a modified Continual Reassessment Method (CRM) for each successive subject until an MTD or the maximal planned dose is reached.
Outcome measures
| Measure |
C134 Treatment
n=14 Participants
All patients who enroll will receive C134 inoculation into their tumor (one time procedure with 1-5 inoculation sites)
|
|---|---|
|
Maximum Tolerated Dose of C134 Treatment
|
31,622,776.6 Plaque-forming units (PFU)
|
SECONDARY outcome
Timeframe: pre-study, day 3, day 28, month 3, month 6, month 12Patients will receive contrast-enhanced MRI to monitor progression (changes in tumor volume or tumor enhancement assessed by the iRANO criteria). As indicated in the criteria, biopsy and/or resection may be performed in instances of uncertainty. Determination of time to progression (in months) will be recorded for each patient and median progression-free survival will be calculated for the entire cohort (Kaplan-Meier).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: day 0, day 1, day 2, day 3, day 7, day 28, month 3, month 6, month 12Patients survival will be recorded (Kaplan-Meier).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-study, day 28, month 3, month 6, month 12Detection and quantification of HSV antibody titer via ELISA, pfu/mL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-study, day 2, day 7, day 28, month 3, month 6, month 12White blood cell subset analysis by FACS, as a percent of total white blood cell number.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-study, day 2, day 7, day 28, month 3, month 6, month 12Intracellular lymphocyte interferon levels will be assessed by FACS analysis ng/mL
Outcome measures
Outcome data not reported
Adverse Events
10^6 Single Dose of C134
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
10^7 Single Dose of C134
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
10^7.5 Single Dose of C134
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
10^5 Single Dose of C134
Serious events: 7 serious events
Other events: 8 other events
Deaths: 6 deaths
10^5.5 Single Dose of C134
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
10^6 Single Dose of C134
n=2 participants at risk
Participants were administered 10\^6 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^7 Single Dose of C134
n=2 participants at risk
Participants were administered 10\^7 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^7.5 Single Dose of C134
n=1 participants at risk
Participants were administered 10\^7.5 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^5 Single Dose of C134
n=8 participants at risk
Participants were administered 10\^5 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^5.5 Single Dose of C134
n=1 participants at risk
Participants were administered 10\^5.5 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
|---|---|---|---|---|---|
|
Nervous system disorders
Neurological
|
100.0%
2/2 • Number of events 3 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 3 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 3 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
87.5%
7/8 • Number of events 11 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 3 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Sensory
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Cardiac disorders
Cardiovascular
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Eye disorders
HEENT
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Blood and lymphatic system disorders
Hematology/Lymphatic
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
Other adverse events
| Measure |
10^6 Single Dose of C134
n=2 participants at risk
Participants were administered 10\^6 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^7 Single Dose of C134
n=2 participants at risk
Participants were administered 10\^7 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^7.5 Single Dose of C134
n=1 participants at risk
Participants were administered 10\^7.5 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^5 Single Dose of C134
n=8 participants at risk
Participants were administered 10\^5 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
10^5.5 Single Dose of C134
n=1 participants at risk
Participants were administered 10\^5.5 single dose of C134 infused through catheters into region(s) of tumor defined by MRI
|
|---|---|---|---|---|---|
|
Nervous system disorders
Acalculia
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
General disorders
Acute mastoiditis of right side
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Cardiac disorders
A-Fib
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Gastrointestinal disorders
Appetite, dry heaves
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Ataxia of left arm
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Eye disorders
Cataracts bilateral
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Cerebral edema
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
25.0%
2/8 • Number of events 2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Collapsed at work, did not lose consciousness
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Confused and difficulty with productive speech CTH
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
CSF positive candida
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
CSF positive for HSV
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Decreased cognitive processing
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Decreased mobility-barely able to walk from room to room with assistance
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Eye disorders
Decreased visual acuity
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Psychiatric disorders
Difficulty sleeping
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Diplopia
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Disease progression
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin, patches
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Ear and labyrinth disorders
Ear pain, right side
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Cardiac disorders
Elevated Blood Pressure
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Immune system disorders
Elevated temperature
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Encephilitis
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Eye disorders
Eye disorders
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Musculoskeletal and connective tissue disorders
Fall
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
General disorders
Fatigue
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
25.0%
2/8 • Number of events 3 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Febrile
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Feels "Loopy"
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Immune system disorders
Fever
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
GBM growth /Increased tumor size
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Musculoskeletal and connective tissue disorders
General deconditioning
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
62.5%
5/8 • Number of events 6 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
General disorders
Lethargy/energy crash
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Hearing decreased
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Hemotoma
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
General disorders
Hyperglycemia
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Hypersensitivity to smell
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Psychiatric disorders
Increased agitation
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Increased intracranial pressure
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Increased sleepiness
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Increased somnolence
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Increased tremors of extremities
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Increased weakness Right side
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Intermittent confusion
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
General disorders
Left homonymous VF defect
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Left sided weakness
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Gastrointestinal disorders
Loss of appetite
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Immune system disorders
Low grade temperature
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Memory impairment
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Mild cognitive symptoms
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Mild syncope when standing from sitting
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Skin and subcutaneous tissue disorders
Morbilliform drug eruption rash
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Slight increase in enhancing, moderate increase vasogenic edema
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Increased enhancement, edema and mass effect
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Blood and lymphatic system disorders
Multiple blood clots in chest in legs
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Muscle weakness
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
25.0%
2/8 • Number of events 3 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Nodule of enhancement concerning for tumor progression
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Not able to communicate, either words not understandable or won't answer questions
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Numbness in right foot and lower leg
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
General disorders
Oral PCR positive for HSV
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
General disorders
Overall decline in subject's status, Hospice initiated
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
General disorders
Pain in right tonsil
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
25.0%
2/8 • Number of events 2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Psychiatric disorders
Photophobia
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Progression of malignant neoplasm
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolus
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Psychiatric disorders
Repetitive activities
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Eye disorders
Retinopathy (bilateral retinitis)
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash on face (after shaving)
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Right facial muscle weakness
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Seizures
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
25.0%
2/8 • Number of events 2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Blood and lymphatic system disorders
Serum Calcium lab value decreased
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Immune system disorders
Serum draw on 9/20 reported Positive for HSV CPT
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
General disorders
Severe headache with nausea
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Short term memory loss
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Significant somatosensory dysfunction to left body
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesions
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Slurred speech
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Small amount of pneumocephalus on CTH
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Somnolent
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Spasticity right sided, worse in upper extremity
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Stumble and fall X3
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Cardiac disorders
Thrombus in cephalic veins bilaterally
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Tumor progression
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
25.0%
2/8 • Number of events 2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Unresponsive/Obtunded - intubated
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Renal and urinary disorders
Urinalysis with trace LE
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
25.0%
2/8 • Number of events 2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Eye disorders
Vision decreased
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Visual disturbances
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
100.0%
1/1 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Eye disorders
Vitreous detachment (floaters)
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Weakness and dystonia
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Worsened dysphasia
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Worsening ataxia (foot drag)
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Worsening cognitive symptoms
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
Nervous system disorders
Worsening speech
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
12.5%
1/8 • Number of events 2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
|
General disorders
Hypernatremia
|
0.00%
0/2 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
50.0%
1/2 • Number of events 1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/8 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
0.00%
0/1 • 12 Months
Adverse events were not collected for participants listed under "Screen Fails". Participants in this group were enrolled, but withdrawn from the study for various reasons, prior to administration of the the study drug.
|
Additional Information
James Markert, MD
The University of Alabama at Birmingham
Phone: 2059347171
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place