Trial Outcomes & Findings for Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma (NCT NCT02062827)
NCT ID: NCT02062827
Last Updated: 2025-10-02
Results Overview
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
baseline to12 months
Results posted on
2025-10-02
Participant Flow
Participant milestones
| Measure |
10^5 Single Dose of HSV-1 (M032)
Participants were administered 10\^5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^6 Single Dose of HSV-1 (M032)
Participants were administered 10\^6 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^7 Single Dose of HSV-1 (M032)
Participants were administered 10\^7 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^7.5 Single Dose of HSV-1 (M032)
Participants were administered 10\^7.5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^8 Single Dose of HSV-1 (M032)
Participants were administered 10\^8 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^8.5 Single Dose of HSV-1 (M032)
Participants were administered 10\^8.5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^9 Single Dose of HSV-1 (M032)
Participants were administered 10\^9 single dose of HSV-1 (M032) 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 M032
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
1
|
2
|
6
|
1
|
6
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
1
|
2
|
6
|
0
|
5
|
8
|
Reasons for withdrawal
| Measure |
10^5 Single Dose of HSV-1 (M032)
Participants were administered 10\^5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^6 Single Dose of HSV-1 (M032)
Participants were administered 10\^6 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^7 Single Dose of HSV-1 (M032)
Participants were administered 10\^7 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^7.5 Single Dose of HSV-1 (M032)
Participants were administered 10\^7.5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^8 Single Dose of HSV-1 (M032)
Participants were administered 10\^8 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^8.5 Single Dose of HSV-1 (M032)
Participants were administered 10\^8.5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^9 Single Dose of HSV-1 (M032)
Participants were administered 10\^9 single dose of HSV-1 (M032) 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 M032
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
1
|
2
|
6
|
0
|
5
|
0
|
|
Overall Study
Screen Fail
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
Baseline Characteristics
Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma
Baseline characteristics by cohort
| Measure |
10^5 Single Dose of HSV-1 (M032)
n=4 Participants
Participants were administered 10\^5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^6 Single Dose of HSV-1 (M032)
n=1 Participants
Participants were administered 10\^6 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^7 Single Dose of HSV-1 (M032)
n=1 Participants
Participants were administered 10\^7 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^7.5 Single Dose of HSV-1 (M032)
n=2 Participants
Participants were administered 10\^7.5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^8 Single Dose of HSV-1 (M032)
n=6 Participants
Participants were administered 10\^8 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^8.5 Single Dose of HSV-1 (M032)
n=1 Participants
Participants were administered 10\^8.5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^9 Single Dose of HSV-1 (M032)
n=6 Participants
Participants were administered 10\^9 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
Screen Fails
n=8 Participants
Participants who consented, but became ineligible prior to receiving M032
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
26 Participants
n=114 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 48.45 • n=99 Participants
|
39 years
STANDARD_DEVIATION 48.45 • n=107 Participants
|
56 years
STANDARD_DEVIATION 48.45 • n=206 Participants
|
42.5 years
STANDARD_DEVIATION 48.45 • n=7 Participants
|
52.67 years
STANDARD_DEVIATION 48.45 • n=31 Participants
|
56 years
STANDARD_DEVIATION 48.45 • n=30 Participants
|
48.83 years
STANDARD_DEVIATION 48.45 • n=3 Participants
|
50 years
STANDARD_DEVIATION 48.5 • n=6 Participants
|
49.07 years
STANDARD_DEVIATION 48.45 • n=114 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
7 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
22 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
29 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=7 Participants
|
6 participants
n=31 Participants
|
1 participants
n=30 Participants
|
6 participants
n=3 Participants
|
8 participants
n=6 Participants
|
29 participants
n=114 Participants
|
PRIMARY outcome
Timeframe: baseline to12 monthsOutcome measures
| Measure |
Single Dose of HSV-1 (M032)
n=21 Participants
Participants were administered 10\^5, 10\^6, 10\^7, 10\^7.5, 10\^8, 10\^8.5, or 10\^9 pfu of single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
|---|---|
|
Maximum Tolerated Dose (MTD) of M032
|
1000000000 plaque-forming units (PFU)
|
SECONDARY outcome
Timeframe: baseline to 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 12 monthsOutcome measures
Outcome data not reported
Adverse Events
10^5 Single Dose of HSV-1 (M032)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 4 deaths
10^6 Single Dose of HSV-1 (M032)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
10^7 Single Dose of HSV-1 (M032)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
10^7.5 Single Dose of HSV-1 (M032)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
10^8 Single Dose of HSV-1 (M032)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 6 deaths
10^8.5 Single Dose of HSV-1 (M032)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
10^9 Single Dose of HSV-1 (M032)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
10^5 Single Dose of HSV-1 (M032)
n=4 participants at risk
Participants were administered 10\^5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^6 Single Dose of HSV-1 (M032)
n=1 participants at risk
Participants were administered 10\^6 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^7 Single Dose of HSV-1 (M032)
n=1 participants at risk
Participants were administered 10\^7 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^7.5 Single Dose of HSV-1 (M032)
n=2 participants at risk
Participants were administered 10\^7.5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^8 Single Dose of HSV-1 (M032)
n=6 participants at risk
Participants were administered 10\^8 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^8.5 Single Dose of HSV-1 (M032)
n=1 participants at risk
Participants were administered 10\^8.5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^9 Single Dose of HSV-1 (M032)
n=6 participants at risk
Participants were administered 10\^9 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Intracranial Infection - intradural
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Left Hemiplegia
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Gastrointestinal disorders
Nausea & vomiting
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Cerebral Herniation
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Coma
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Vascular disorders
Hyponatremia
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Insufficiency
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Right Lower Extremity Monoplegia
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Strokes, bilateral
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Skin and subcutaneous tissue disorders
Worsening Papular, Pustular rash
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Vascular disorders
Edema Left ankle/foot
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
General disorders
Fatigue
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
50.0%
1/2 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
General disorders
Headache
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
50.0%
1/2 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
100.0%
1/1 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Surgical and medical procedures
Surgical wound not healing
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
100.0%
1/1 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
Other adverse events
| Measure |
10^5 Single Dose of HSV-1 (M032)
n=4 participants at risk
Participants were administered 10\^5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^6 Single Dose of HSV-1 (M032)
n=1 participants at risk
Participants were administered 10\^6 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^7 Single Dose of HSV-1 (M032)
n=1 participants at risk
Participants were administered 10\^7 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^7.5 Single Dose of HSV-1 (M032)
n=2 participants at risk
Participants were administered 10\^7.5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^8 Single Dose of HSV-1 (M032)
n=6 participants at risk
Participants were administered 10\^8 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^8.5 Single Dose of HSV-1 (M032)
n=1 participants at risk
Participants were administered 10\^8.5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
10^9 Single Dose of HSV-1 (M032)
n=6 participants at risk
Participants were administered 10\^9 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
|
|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Aphasia
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
33.3%
2/6 • Number of events 2 • 12 months
|
|
Nervous system disorders
Ataxia
|
25.0%
1/4 • Number of events 2 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Bilateral nystagmus
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Blurred Vision
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
50.0%
1/2 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
General disorders
Body Aches
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Bowel incontinence
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Vascular disorders
Bruising
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
BUE tremors
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
General disorders
Chills
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Classic Candida Rash to groin
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Constant black floaters
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
33.3%
2/6 • Number of events 3 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Corneal abrasion
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
General disorders
Chest Pain
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Crush injury to right elbow
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Nervous system disorders
Decreased fine motor movement
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Eye disorders
Decreased visual field left eye, left side
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
50.0%
1/2 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Diplopia
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
33.3%
2/6 • Number of events 2 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Dysesthesia
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Ear and labyrinth disorders
Ear Infection
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
100.0%
1/1 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Vascular disorders
Elevated blood pressure
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Emesis
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Renal and urinary disorders
Enuresis
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
50.0%
1/2 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
50.0%
1/2 • Number of events 1 • 12 months
|
50.0%
3/6 • Number of events 4 • 12 months
|
0.00%
0/1 • 12 months
|
33.3%
2/6 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Fine motor slowing right hand
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Gait Disturbance
|
75.0%
3/4 • Number of events 5 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
33.3%
2/6 • Number of events 3 • 12 months
|
|
Renal and urinary disorders
Increased blood urea nitrogen
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Increased left sided weakness
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Itching/dry eyes
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Itching/Rash
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Left ankle sprain
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
General disorders
Left arm & Right leg pain
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
50.0%
1/2 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Left facial weakness
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Left upper extremity weakness
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Left eye double vision
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Left lower extremity muscle weakness against resistance
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
General disorders
Left lower extremity weakness
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Left side proprioception
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
General disorders
Left side weakness
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
25.0%
1/4 • Number of events 2 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Lose of Balance
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right side
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Gastrointestinal disorders
Nausea & vomiting
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
100.0%
1/1 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Skin and subcutaneous tissue disorders
Non-pruritic red raised pustule rash on face, chest and back
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
General disorders
Pain & swelling L foot/ankle gout flare up
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
50.0%
1/2 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Skin and subcutaneous tissue disorders
Petechia left arm
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Skin and subcutaneous tissue disorders
Psoriasis - worsening
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Right facial droop
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
General disorders
Right hip joint pain
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash to arms
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
50.0%
1/2 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Skin and subcutaneous tissue disorders
Redness to arms and legs
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Nervous system disorders
Right hand weakness
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Nervous system disorders
Right lower extremity weakness
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Ear and labyrinth disorders
Right side eye and cheek swelling
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Right upper extremity weakness
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
General disorders
Runny nose
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
33.3%
2/6 • Number of events 2 • 12 months
|
|
General disorders
Sinus Congestion
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin discoloration red area back & abdomen
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
General disorders
Sleepiness
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
General disorders
Somnolence
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
General disorders
Sore throat
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Nervous system disorders
Spasms
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Tingling LLE
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Renal and urinary disorders
Urinary flow issues
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Urinary incontinence
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Eye disorders
Quadrantanopia
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Eye disorders
Visual field deficit left
|
25.0%
1/4 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
General disorders
Word finding difficulty
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Nervous system disorders
Worsening balance, coordination and right side weakness
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
0.00%
0/6 • 12 months
|
0.00%
0/1 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Nervous system disorders
Worsening hemiparesis, left
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Ear and labyrinth disorders
Yellow/Brown drainage left ear
|
0.00%
0/4 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
0.00%
0/1 • 12 months
|
0.00%
0/6 • 12 months
|
Additional Information
James Markert, MD
The University of Alabama at Birmingham
Phone: (205) 934-7171
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place