Trial Outcomes & Findings for Using a Head and Neck Maskless Immobilization Device For Patients With Intracranial Tumors (NCT NCT03076255)

Last Updated: 2025-10-15

Results Overview

The primary endpoints are to assess the setup accuracy and reproducibility with the Maskless Immobilization Device. Accuracy will be measured by quantifying the difference in translational shifts from the daily setup to planning CT scan digitally reconstructed radiograph (DRR). The magnitude of shifts will be compared to the shifts required using the gold standard thermoplastic mask. Translational shifts is defined as measuring the shifts in cm between the daily setup and the planning setup.

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

Baseline to Day 15, an average of 31 days

Results posted on

2025-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	Supportive care (MID) Patients undergo Computed Tomography (CT) simulation with thermoplastic mask and maskless immobilization device (MID) for radiation therapy (RT) planning on day 1. Patients undergo standard of care RT using thermoplastic mask only and cone-beam computed tomography (CBCT) imaging with thermoplastic mask and MID on day 8 and 15. Computed Tomography: Undergo CT simulation Medical Device: Given thermoplastic mask Medical Device: Given MID Cone-Beam Computed Tomography: Undergo CBCT imaging
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Using a Head and Neck Maskless Immobilization Device For Patients With Intracranial Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supportive care (MID) n=12 Participants Patients undergo Computed Tomography (CT) simulation with thermoplastic mask and maskless immobilization device (MID) for radiation therapy (RT) planning on day 1. Patients undergo standard of care RT using thermoplastic mask only and cone-beam computed tomography (CBCT) imaging with thermoplastic mask and MID on day 8 and 15. Computed Tomography: Undergo CT simulation Medical Device: Given thermoplastic mask Medical Device: Given MID Cone-Beam Computed Tomography: Undergo CBCT imaging
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race/Ethnicity, Customized White	11 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Day 15, an average of 31 days

Outcome measures

Outcome measures
Measure	Supportive care (MID) n=12 Participants Patients undergo Computed Tomography (CT) simulation with thermoplastic mask and maskless immobilization device (MID) for radiation therapy (RT) planning on day 1. Patients undergo standard of care RT using thermoplastic mask only and cone-beam computed tomography (CBCT) imaging with thermoplastic mask and MID on day 8 and 15. Computed Tomography: Undergo CT simulation Medical Device: Given thermoplastic mask Medical Device: Given MID Cone-Beam Computed Tomography: Undergo CBCT imaging
Accuracy Measured by Quantifying the Difference in Translational Shifts From the Daily Setup to Planning CT Scan Digitally Reconstructed Radiograph Vertical	0.08 centimeters (cm) Standard Deviation 0.30
Accuracy Measured by Quantifying the Difference in Translational Shifts From the Daily Setup to Planning CT Scan Digitally Reconstructed Radiograph Longitudinal	0.16 centimeters (cm) Standard Deviation 0.52
Accuracy Measured by Quantifying the Difference in Translational Shifts From the Daily Setup to Planning CT Scan Digitally Reconstructed Radiograph Lateral	-0.02 centimeters (cm) Standard Deviation 0.47

Adverse Events

Supportive care (MID)

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Supportive care (MID) n=12 participants at risk Patients undergo Computed Tomography (CT) simulation with thermoplastic mask and maskless immobilization device (MID) for radiation therapy (RT) planning on day 1. Patients undergo standard of care RT using thermoplastic mask only and cone-beam computed tomography (CBCT) imaging with thermoplastic mask and MID on day 8 and 15. Computed Tomography: Undergo CT simulation Medical Device: Given thermoplastic mask Medical Device: Given MID Cone-Beam Computed Tomography: Undergo CBCT imaging
Endocrine disorders Hyperglycemia - Grade IV	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Endocrine disorders DKA	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Endocrine disorders Dehydration - Grade 3	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.

Other adverse events

Other adverse events
Measure	Supportive care (MID) n=12 participants at risk Patients undergo Computed Tomography (CT) simulation with thermoplastic mask and maskless immobilization device (MID) for radiation therapy (RT) planning on day 1. Patients undergo standard of care RT using thermoplastic mask only and cone-beam computed tomography (CBCT) imaging with thermoplastic mask and MID on day 8 and 15. Computed Tomography: Undergo CT simulation Medical Device: Given thermoplastic mask Medical Device: Given MID Cone-Beam Computed Tomography: Undergo CBCT imaging
Psychiatric disorders depression	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Gastrointestinal disorders GERD	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Reproductive system and breast disorders obstructive sleep apnea	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
General disorders headache	25.0% 3/12 • Number of events 3 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Metabolism and nutrition disorders Obesity	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Psychiatric disorders Anxiety	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Blood and lymphatic system disorders Lymphedema	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Vascular disorders hypertension	33.3% 4/12 • Number of events 4 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Cardiac disorders Tachycardia	16.7% 2/12 • Number of events 2 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Eye disorders Visual Disturbance	16.7% 2/12 • Number of events 2 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Eye disorders Optic Nerve Disorder	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Nervous system disorders Tremor	33.3% 4/12 • Number of events 4 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Nervous system disorders Seizure	25.0% 3/12 • Number of events 3 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Metabolism and nutrition disorders Metabolic acidosis	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Nervous system disorders Cerebral Edema	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Eye disorders Eye pain	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Eye disorders Photophobia	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Nervous system disorders Ulnar neuropraxia	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Eye disorders watering eyes	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Psychiatric disorders Flat Affect	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Skin and subcutaneous tissue disorders Erythema (abdomen)	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Skin and subcutaneous tissue disorders Scar Weeping	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
General disorders Right upper extremity weakness	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Blood and lymphatic system disorders Anemia	33.3% 4/12 • Number of events 4 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Metabolism and nutrition disorders Weight loss	16.7% 2/12 • Number of events 2 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Gastrointestinal disorders Constipation	16.7% 2/12 • Number of events 2 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Skin and subcutaneous tissue disorders Papular rash	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Skin and subcutaneous tissue disorders Pruritus	25.0% 3/12 • Number of events 3 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Nervous system disorders Dizziness	25.0% 3/12 • Number of events 3 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Psychiatric disorders Agitation	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Eye disorders Floppy eyelid syndrome	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Vascular disorders Chronic venous stasis	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Blood and lymphatic system disorders Hyperglycemia	33.3% 4/12 • Number of events 4 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Renal and urinary disorders Abnormal Urine Culture	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Renal and urinary disorders Proteinuria	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Renal and urinary disorders Hypocalcemia	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Renal and urinary disorders Hypermagnesemia	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Blood and lymphatic system disorders INR increased	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Metabolism and nutrition disorders increased appetite	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
General disorders fatigue	50.0% 6/12 • Number of events 6 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Respiratory, thoracic and mediastinal disorders apnea	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Gastrointestinal disorders Blood in stool	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Gastrointestinal disorders rectal pain	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Hepatobiliary disorders ALP increased	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Skin and subcutaneous tissue disorders Paresthesia	16.7% 2/12 • Number of events 2 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Skin and subcutaneous tissue disorders Diaphoretic	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Infections and infestations hemorrhagic per-rectal abscess	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Ear and labyrinth disorders Tinnitus	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
General disorders Dysosmia	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Musculoskeletal and connective tissue disorders Gait disturbance	33.3% 4/12 • Number of events 4 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Immune system disorders Alopecia	25.0% 3/12 • Number of events 3 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Blood and lymphatic system disorders Hypernatremia	16.7% 2/12 • Number of events 2 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Renal and urinary disorders Urine discoloration	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Skin and subcutaneous tissue disorders Radiation dermatitis	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Blood and lymphatic system disorders lymphocyte count decreased	16.7% 2/12 • Number of events 2 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
General disorders esophageal pain	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
General disorders Insomnia	25.0% 3/12 • Number of events 3 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Skin and subcutaneous tissue disorders Rash	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Blood and lymphatic system disorders Bruises easily	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
General disorders Dysarthria	25.0% 3/12 • Number of events 3 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Nervous system disorders Paresthesia	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Skin and subcutaneous tissue disorders Skin color change	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Ear and labyrinth disorders Hearing impairment	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Musculoskeletal and connective tissue disorders Hand cramping	16.7% 2/12 • Number of events 2 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Psychiatric disorders Cognitive disturbance	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Skin and subcutaneous tissue disorders Nevi	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Skin and subcutaneous tissue disorders Ecchymosis	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Psychiatric disorders Irritability	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Injury, poisoning and procedural complications Cracked tooth	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Endocrine disorders Diabetes Mellitus	16.7% 2/12 • Number of events 2 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Musculoskeletal and connective tissue disorders Left hand disability	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Blood and lymphatic system disorders Hyperlipidemia	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
General disorders Ataxia	16.7% 2/12 • Number of events 2 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Musculoskeletal and connective tissue disorders Muscle spasms	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Congenital, familial and genetic disorders Delirium	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Nervous system disorders Memory impairment	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Surgical and medical procedures Pain - incision site	16.7% 2/12 • Number of events 2 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
General disorders nausea/vomiting	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Blood and lymphatic system disorders hypocholesteremia	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
General disorders Ear pain	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
Psychiatric disorders Apathy	8.3% 1/12 • Number of events 1 • Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation. An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.

Additional Information

Voichita Bar-Ad, MD

Thomas Jefferson University

Phone: 215-955-6702

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place