Trial Outcomes & Findings for Efficacy in iNPH Shunting (PENS) Trial (NCT NCT05081128)
NCT ID: NCT05081128
Last Updated: 2026-08-27
Results Overview
Evaluation of CSF shunting in iNPH patients through a group comparison of change from baseline at three months between active and placebo-controlled groups, using the primary endpoint of gait velocity (in meters per second).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
Baseline and 3 months
Results posted on
2026-08-27
Participant Flow
Participant milestones
| Measure |
Open Shunt
The open-shunt group was assigned valve setting 4 (opening pressure, 110 mm of water); however, valve settings 5 and 6 (145 or 180 mm of water, respectively) were allowed at the surgeon's discretion for participant safety.
|
Placebo
The placebo group was assigned valve setting 8 (opening pressure, \>400 mm of water).
|
|---|---|---|
|
3 Months Post-Op
COMPLETED
|
49
|
46
|
|
3 Months Post-Op
STARTED
|
49
|
50
|
|
3 Months Post-Op
NOT COMPLETED
|
0
|
4
|
|
12 Months Active Shunting
STARTED
|
49
|
46
|
|
12 Months Active Shunting
COMPLETED
|
49
|
43
|
|
12 Months Active Shunting
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Open Shunt
The open-shunt group was assigned valve setting 4 (opening pressure, 110 mm of water); however, valve settings 5 and 6 (145 or 180 mm of water, respectively) were allowed at the surgeon's discretion for participant safety.
|
Placebo
The placebo group was assigned valve setting 8 (opening pressure, \>400 mm of water).
|
|---|---|---|
|
3 Months Post-Op
Withdrawal by Subject
|
0
|
3
|
|
3 Months Post-Op
Death
|
0
|
1
|
|
12 Months Active Shunting
Physician Decision
|
0
|
1
|
|
12 Months Active Shunting
Death
|
0
|
2
|
Baseline Characteristics
Efficacy in iNPH Shunting (PENS) Trial
Baseline characteristics by cohort
| Measure |
Open Shunt
n=49 Participants
The open-shunt group was assigned valve setting 4 (opening pressure, 110 mm of water); however, valve settings 5 and 6 (145 or 180 mm of water, respectively) were allowed at the surgeon's discretion for participant safety.
|
Placebo
n=50 Participants
The placebo group was assigned valve setting 8 (opening pressure, \>400 mm of water).
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.1 Years
STANDARD_DEVIATION 5.7 • n=31 Participants
|
74.9 Years
STANDARD_DEVIATION 5.8 • n=49 Participants
|
75.0 Years
STANDARD_DEVIATION 5.7 • n=80 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=31 Participants
|
25 Participants
n=49 Participants
|
48 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=31 Participants
|
25 Participants
n=49 Participants
|
51 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
5 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
3 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=31 Participants
|
45 Participants
n=49 Participants
|
90 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
2 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=31 Participants
|
50 Participants
n=49 Participants
|
97 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Baseline Gait Velocity (m/s)
|
0.87 m/s
STANDARD_DEVIATION 0.25 • n=31 Participants
|
0.82 m/s
STANDARD_DEVIATION 0.27 • n=49 Participants
|
0.84 m/s
STANDARD_DEVIATION 0.26 • n=80 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: One participant in the placebo group who underwent randomization was deceased at the 3-month time point and is not included in this analysis.
Evaluation of CSF shunting in iNPH patients through a group comparison of change from baseline at three months between active and placebo-controlled groups, using the primary endpoint of gait velocity (in meters per second).
Outcome measures
| Measure |
Open Shunt
n=49 Participants
The open-shunt group was assigned valve setting 4 (opening pressure, 110 mm of water); however, valve settings 5 and 6 (145 or 180 mm of water, respectively) were allowed at the surgeon's discretion for participant safety.
|
Placebo
n=49 Participants
The placebo group was assigned valve setting 8 (opening pressure, \>400 mm of water).
|
|---|---|---|
|
Change in Gait Velocity
|
0.23 m/s
Standard Deviation 0.23
|
0.03 m/s
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: One participant in the placebo group who underwent randomization was deceased at the 3-month time point and is not included in this analysis.
Evaluate the effect of shunting between active and placebo-controlled groups at three months using MoCA test to assess cognition. Scores on the MoCA range from 0 to 30, with a score of 26 and higher generally considered normal.
Outcome measures
| Measure |
Open Shunt
n=49 Participants
The open-shunt group was assigned valve setting 4 (opening pressure, 110 mm of water); however, valve settings 5 and 6 (145 or 180 mm of water, respectively) were allowed at the surgeon's discretion for participant safety.
|
Placebo
n=49 Participants
The placebo group was assigned valve setting 8 (opening pressure, \>400 mm of water).
|
|---|---|---|
|
Change in Cognition as Assessed by the Montreal Cognitive Assessment (MoCA)
|
1.3 score on a scale
Standard Deviation 2.1
|
0.3 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: One participant in the placebo group who underwent randomization was deceased at the 3-month time point and is not included in this analysis.
Evaluate the effect of shunting between active and placebo-controlled groups at three months using Overactive Bladder Questionnaire, short form (OAB-q sf.) to assess bladder control. Total score range 0- to 100, with lower score indicating greater effect, i.e., worse QOL.
Outcome measures
| Measure |
Open Shunt
n=49 Participants
The open-shunt group was assigned valve setting 4 (opening pressure, 110 mm of water); however, valve settings 5 and 6 (145 or 180 mm of water, respectively) were allowed at the surgeon's discretion for participant safety.
|
Placebo
n=49 Participants
The placebo group was assigned valve setting 8 (opening pressure, \>400 mm of water).
|
|---|---|---|
|
Change in Bladder Control as Assessed by the Overactive Bladder Questionnaire, Short Form
|
-3.3 score on a scale
Standard Deviation 6.4
|
-1.5 score on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: One participant in the placebo group who underwent randomization was deceased at the 3-month time point and is not included in this analysis.
Evaluate the effect of shunting between active and placebo-controlled groups at three months using Tinetti Score to assess balance and gait. Scores on the Tinetti range from 0 to 28. The higher the score the better the gait and balance performance.
Outcome measures
| Measure |
Open Shunt
n=49 Participants
The open-shunt group was assigned valve setting 4 (opening pressure, 110 mm of water); however, valve settings 5 and 6 (145 or 180 mm of water, respectively) were allowed at the surgeon's discretion for participant safety.
|
Placebo
n=49 Participants
The placebo group was assigned valve setting 8 (opening pressure, \>400 mm of water).
|
|---|---|---|
|
Change in Balance and Gait as Assessed by the Tinetti Score
|
2.9 score on a scale
Standard Deviation 3.8
|
0.5 score on a scale
Standard Deviation 5.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 months of active shuntingEvaluate the effect of shunting between active and placebo-controlled groups at nine months using Overactive Bladder Questionnaire, short form (OAB-q sf.) to assess bladder control. All scale scores are transformed to a 0- to 100-point scale, with lower scores indicating greater effect, i.e., worse QOL.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 months of active shuntingEvaluate the change in gait velocity among all study participants between baseline and 12 months of active shunting, using the primary outcome of gait velocity (in meters per second).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12 months of active shuntingEvaluate the effect of shunting between active and placebo-controlled groups at nine months using MoCA test to assess cognition. Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.
Outcome measures
Outcome data not reported
Adverse Events
Open Shunt
Serious events: 18 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo
Serious events: 16 serious events
Other events: 40 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Open Shunt
n=49 participants at risk
The open-shunt group was assigned valve setting 4 (opening pressure, 110 mm of water); however, valve settings 5 and 6 (145 or 180 mm of water, respectively) were allowed at the surgeon's discretion for participant safety.
|
Placebo
n=50 participants at risk
The placebo group was assigned valve setting 8 (opening pressure, \>400 mm of water).
|
|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Nervous system disorders
Subdural effusion
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Nervous system disorders
Subdural hygroma
|
4.1%
2/49 • Number of events 2 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Nervous system disorders
Syncope
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Eye disorders
Visual impairment
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
General disorders
Drug-disease interaction
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
General disorders
Pyrexia
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Infections and infestations
COVID-19 pneumonia
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Infections and infestations
Erysipelas
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Infections and infestations
Pneumonia
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 3 • From enrollment up to 30 days post shunt adjustment
|
|
Injury, poisoning and procedural complications
Foreign body ingestion
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Cardiac disorders
Sinus Node Disfunction
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Cardiac disorders
Supraventricular Tachycardia
|
2.0%
1/49 • Number of events 2 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
8.2%
4/49 • Number of events 6 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Injury, poisoning and procedural complications
Wound decomposition
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Investigations
Troponin abnormal
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Investigations
Troponin increased
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Nervous system disorders
Aphasia
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Nervous system disorders
Cerebral haemorrhage
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Nervous system disorders
Encephalopathy
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Nervous system disorders
Headache
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Nervous system disorders
Hydrocephalus
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Nervous system disorders
Intracranial hypotension
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Nervous system disorders
Loss of consciousness
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Social circumstances
Inadequate housing
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Vascular disorders
Iliac artery stenosis
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/49 • Number of events 2 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Cardiac disorders
Acute myocardial infarction
|
2.0%
1/49 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
Other adverse events
| Measure |
Open Shunt
n=49 participants at risk
The open-shunt group was assigned valve setting 4 (opening pressure, 110 mm of water); however, valve settings 5 and 6 (145 or 180 mm of water, respectively) were allowed at the surgeon's discretion for participant safety.
|
Placebo
n=50 participants at risk
The placebo group was assigned valve setting 8 (opening pressure, \>400 mm of water).
|
|---|---|---|
|
Nervous system disorders
Subdural hygroma
|
14.3%
7/49 • Number of events 7 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Gastrointestinal disorders
Abdominal pain
|
12.2%
6/49 • Number of events 6 • From enrollment up to 30 days post shunt adjustment
|
6.0%
3/50 • Number of events 3 • From enrollment up to 30 days post shunt adjustment
|
|
Gastrointestinal disorders
Nausea
|
4.1%
2/49 • Number of events 2 • From enrollment up to 30 days post shunt adjustment
|
6.0%
3/50 • Number of events 3 • From enrollment up to 30 days post shunt adjustment
|
|
General disorders
Fatigue
|
8.2%
4/49 • Number of events 4 • From enrollment up to 30 days post shunt adjustment
|
2.0%
1/50 • Number of events 1 • From enrollment up to 30 days post shunt adjustment
|
|
Infections and infestations
Cystitis
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
6.0%
3/50 • Number of events 3 • From enrollment up to 30 days post shunt adjustment
|
|
Infections and infestations
Urinary tract infection
|
6.1%
3/49 • Number of events 3 • From enrollment up to 30 days post shunt adjustment
|
8.0%
4/50 • Number of events 9 • From enrollment up to 30 days post shunt adjustment
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
8.0%
4/50 • Number of events 4 • From enrollment up to 30 days post shunt adjustment
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
10.2%
5/49 • Number of events 7 • From enrollment up to 30 days post shunt adjustment
|
10.0%
5/50 • Number of events 7 • From enrollment up to 30 days post shunt adjustment
|
|
Nervous system disorders
Dizziness
|
0.00%
0/49 • From enrollment up to 30 days post shunt adjustment
|
6.0%
3/50 • Number of events 3 • From enrollment up to 30 days post shunt adjustment
|
|
Nervous system disorders
Headache
|
36.7%
18/49 • Number of events 20 • From enrollment up to 30 days post shunt adjustment
|
38.0%
19/50 • Number of events 27 • From enrollment up to 30 days post shunt adjustment
|
|
Nervous system disorders
Subdural effusion
|
6.1%
3/49 • Number of events 3 • From enrollment up to 30 days post shunt adjustment
|
0.00%
0/50 • From enrollment up to 30 days post shunt adjustment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place