Trial Outcomes & Findings for Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma (NCT NCT04305470)
NCT ID: NCT04305470
Last Updated: 2026-05-18
Results Overview
Responders are defined as the percentage of participants among all participants receiving Gleolan (the Intent to Image Population) who had at least one indeterminate tissue or unexpected fluorescent end of surgery (EOS) tissue where Gleolan-induced PpIX fluorescence status was consistent with central laboratory histology. For a participant to be considered a success, only biopsies considered 'non-obvious' for tumor status by an external panel of neurosurgeons who reviewed videos and images were eligible to be assessed in the numerator. A two-sided 95% confidence interval was calculated using the Wilson (score) method. The lower bound of the confidence interval was tested against a null hypothesis value of 30%. A modified worst-case imputation was used for missing data.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
108 participants
Primary outcome timeframe
Surgery (Day 1)
Results posted on
2026-05-18
Participant Flow
Recruitment began on October 28th, 2020 and accrual ended on November 7th, 2022. The last patient last vist was December 13, 2022, however, data collection was not complete until the external panel of neuorsurgeons reviewed surgical images and videos on June 6, 2024.
Participants were screened up to 30 days prior to surgery
Participant milestones
| Measure |
Single Arm
Open-label, single-arm. Participants received an oral dose of 20 mg/kg Gleolan 2-4 hours prior to anesthesia and underwent intraoperative fluorescence imaging.
|
|---|---|
|
Overall Study
STARTED
|
108
|
|
Overall Study
COMPLETED
|
99
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma
Baseline characteristics by cohort
| Measure |
Single Arm
n=108 Participants
Open-label, single-arm
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
83 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=11 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=11 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=11 Participants
|
|
Race (NIH/OMB)
White
|
98 Participants
n=11 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
97 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
|
Region
US
|
83 Participants
n=11 Participants
|
|
Region
Non-US (Germany, Austria)
|
25 Participants
n=11 Participants
|
PRIMARY outcome
Timeframe: Surgery (Day 1)Responders are defined as the percentage of participants among all participants receiving Gleolan (the Intent to Image Population) who had at least one indeterminate tissue or unexpected fluorescent end of surgery (EOS) tissue where Gleolan-induced PpIX fluorescence status was consistent with central laboratory histology. For a participant to be considered a success, only biopsies considered 'non-obvious' for tumor status by an external panel of neurosurgeons who reviewed videos and images were eligible to be assessed in the numerator. A two-sided 95% confidence interval was calculated using the Wilson (score) method. The lower bound of the confidence interval was tested against a null hypothesis value of 30%. A modified worst-case imputation was used for missing data.
Outcome measures
| Measure |
Biopsy Efficacy Analysis Population
n=108 Participants
To mitigate potential surgeon bias in biopsy selection, the BEAP included Indeterminate tissues and Unexpected fluorescent EOS tissues considered 'non-obvious' for tumor status by an external panel of neurosurgeons who reviewed videos and images
|
|---|---|
|
The Percentage of Participants Who Had at Least 1 Indeterminate Tissue or Unexpected Fluorescent End of Surgery (EOS) Tissue Where Gleolan-induced PpIX Fluorescence Status is Consistent With Histology (i.e., True Positive or True Negative for Meningioma).
|
60.2 Percentage of Participants
Interval 50.76 to 68.91
|
SECONDARY outcome
Timeframe: Surgery (Day 1)PPV calculation considers both indeterminate and unexpected fluorescent end-of-surgery tissues. Generalized Estimating Equation (GEE) models that take into account the correlation (clustering) of the biopsies within a participant were used to calculate the estimates and two-sided 95% confidence intervals. The models used a binomial distribution function with an exchangeable working correlation matrix and utilized a robust variance estimator. PPV = TP/(TP+FP) TP = True Positive; FP = False Positive; The truth standard was determined via central histopathology.
Outcome measures
| Measure |
Biopsy Efficacy Analysis Population
n=211 Biopsied tissue locations
To mitigate potential surgeon bias in biopsy selection, the BEAP included Indeterminate tissues and Unexpected fluorescent EOS tissues considered 'non-obvious' for tumor status by an external panel of neurosurgeons who reviewed videos and images
|
|---|---|
|
Positive Predicted Value (PPV) of Gleolan-induced PpIX Fluorescence Status of Biopsied Tissue Locations at the Margin of the Tumor [Indeterminate Tissues and Unexpected Fluorescent EOS Tissues (Combined)].
|
65.13 percentage of biopsies
Interval 50.03 to 77.7
|
SECONDARY outcome
Timeframe: Surgery (Day 1)NPV calculation considered indeterminate tissues only since unexpected fluorescent end-of-surgery tissues were, by definition, fluorescence positive. Generalized Estimating Equation (GEE) models that take into account the correlation (clustering) of the biopsies within a participant were used to calculate the estimates and two-sided 95% confidence intervals. The models used a binomial distribution function with an exchangeable working correlation matrix and utilized a robust variance estimator. NPV = TN/(TN+FN) TN = True Negative; FN = False Negative; The truth standard was determined via central histopathology.
Outcome measures
| Measure |
Biopsy Efficacy Analysis Population
n=171 Biopsied tissue locations
To mitigate potential surgeon bias in biopsy selection, the BEAP included Indeterminate tissues and Unexpected fluorescent EOS tissues considered 'non-obvious' for tumor status by an external panel of neurosurgeons who reviewed videos and images
|
|---|---|
|
Negative Predicted Value (NPV) of Gleolan-induced PpIX Fluorescence Status of Biopsied Tissue Locations at the Margin of the Tumor [Indeterminate Tissues].
|
59.04 percentage of biopsies
Interval 49.68 to 67.78
|
SECONDARY outcome
Timeframe: Surgery (Day 1)PPV (PPV=TP/(TP+FP)) of Gleolan-induced PpIX fluorescence status of biopsied tissue locations of bulk/core meningioma tumor
Outcome measures
| Measure |
Biopsy Efficacy Analysis Population
n=100 Participants
To mitigate potential surgeon bias in biopsy selection, the BEAP included Indeterminate tissues and Unexpected fluorescent EOS tissues considered 'non-obvious' for tumor status by an external panel of neurosurgeons who reviewed videos and images
|
|---|---|
|
Positive Predictive Value of Single Bulk Tumor Sample Obtained From Each Participant.
|
94.37 percentage of participants
Interval 86.39 to 97.79
|
Adverse Events
Safety Population
Serious events: 17 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Population
n=108 participants at risk
All Participants who received any amount of Gleolan
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Gastrointestinal disorders
Faecaloma
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
General disorders
Peripheral swelling
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Infections and infestations
Escherichia infection
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Injury, poisoning and procedural complications
Weaning failure
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Hepatobiliary disorders
Hyponatraemia
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Nervous system disorders
Aphasia
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Nervous system disorders
Monoparesis
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Nervous system disorders
Paraparesis
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Nervous system disorders
Posthaemorrhagic hydrocephalus
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Nervous system disorders
Seizure cluster
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Psychiatric disorders
Delirium
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Nervous system disorders
Pulmonary embolism
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Vascular disorders
Deep vein thrombosis
|
3.7%
4/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Vascular disorders
Orthostatic hypotension
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Vascular disorders
Thrombosis
|
0.93%
1/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
Other adverse events
| Measure |
Safety Population
n=108 participants at risk
All Participants who received any amount of Gleolan
|
|---|---|
|
Cardiac disorders
Bradycardia
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Eye disorders
Eyelid ptosis
|
2.8%
3/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Eye disorders
Vision blurred
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Gastrointestinal disorders
Constipation
|
2.8%
3/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Gastrointestinal disorders
Nausea
|
4.6%
5/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
6/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
General disorders
Gait disturbance
|
2.8%
3/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Infections and infestations
COVID-19
|
3.7%
4/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Infections and infestations
Pneumonia
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Infections and infestations
Urinary tract infection
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
4.6%
5/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Injury, poisoning and procedural complications
Incision site swelling
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
2.8%
3/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.8%
3/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Investigations
Hepatic enzyme increased
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.8%
3/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Nervous system disorders
Aphasia
|
5.6%
6/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Nervous system disorders
Headache
|
7.4%
8/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Nervous system disorders
Hemiparesis
|
3.7%
4/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Nervous system disorders
IVth nerve paralysis
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Nervous system disorders
Monoparesis
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Nervous system disorders
Seizure
|
3.7%
4/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Nervous system disorders
Somnolence
|
2.8%
3/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Psychiatric disorders
Confusional state
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Psychiatric disorders
Disorientation
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Psychiatric disorders
Hallucination, visual
|
1.9%
2/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Psychiatric disorders
Insomnia
|
4.6%
5/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
|
Vascular disorders
Hypotension
|
2.8%
3/108 • Recorded from the time the Informed Consent is obtained through the End of Study visit (6 weeks after surgery)
The definitions of AEs and SAEs for this study were consistent with the clinicaltrials.gov definitions and NCI CTCAE version 5.0 grading scales.
|
Additional Information
Michael Giammona, Senior Director, Clinical Operations
NX Development Corporation
Phone: 512-348-3885
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place