Trial Outcomes & Findings for Enhanced Quality in Primary Care for Elders With Diabetes and Dementia (NCT NCT03723707)

NCT ID: NCT03723707

Last Updated: 2023-11-09

Results Overview

Percentage of patients with normal HbA1c (\>=7 and \<=8.5) at the end of the trial after completing the 24-month Follow-up and who had reported values in their electronic health record within 6 months of study completion.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 355 participants
• Primary outcome timeframe: Up to Month 24
• Results posted on: 2023-11-09

Participant Flow

Participant milestones

Measure	Intervention (INT) (10 clinic sites and \~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM) EQUIPED-ADRD Intervention: (10 clinic sites and \~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM)	Control (CON) During training the CON providers will be encouraged to do cognitive screening as well as follow the guidelines in general. Control (CON): Will use current guidelines for primary care treatment with Diabetes and Dementia
Overall Study STARTED	191	164
Overall Study COMPLETED	68	78
Overall Study NOT COMPLETED	123	86

Reasons for withdrawal

Measure	Intervention (INT) (10 clinic sites and \~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM) EQUIPED-ADRD Intervention: (10 clinic sites and \~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM)	Control (CON) During training the CON providers will be encouraged to do cognitive screening as well as follow the guidelines in general. Control (CON): Will use current guidelines for primary care treatment with Diabetes and Dementia
Overall Study Death	32	32
Overall Study Admitted to long term care	12	12
Overall Study No longer receiving care at NYU Langone Health	15	8
Overall Study Lost to Follow-up	40	22
Overall Study Discontinued after study closure	24	12

Baseline Characteristics

Enhanced Quality in Primary Care for Elders With Diabetes and Dementia

Baseline characteristics by cohort

Measure	Intervention (INT) n=68 Participants (10 clinic sites and \~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM) EQUIPED-ADRD Intervention: (10 clinic sites and \~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM)	Control (CON) n=78 Participants During training the CON providers will be encouraged to do cognitive screening as well as follow the guidelines in general. Control (CON): Will use current guidelines for primary care treatment with Diabetes and Dementia	Total n=146 Participants Total of all reporting groups
Age, Continuous	79.5 years STANDARD_DEVIATION 7.21 • n=93 Participants	79 years STANDARD_DEVIATION 7.37 • n=4 Participants	79 years STANDARD_DEVIATION 7.27 • n=27 Participants
Sex: Female, Male Female	38 Participants n=93 Participants	49 Participants n=4 Participants	87 Participants n=27 Participants
Sex: Female, Male Male	30 Participants n=93 Participants	29 Participants n=4 Participants	59 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=93 Participants	29 Participants n=4 Participants	53 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=93 Participants	49 Participants n=4 Participants	93 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	6 Participants n=93 Participants	6 Participants n=4 Participants	12 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	13 Participants n=93 Participants	14 Participants n=4 Participants	27 Participants n=27 Participants
Race (NIH/OMB) White	48 Participants n=93 Participants	58 Participants n=4 Participants	106 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	68 participants n=93 Participants	78 participants n=4 Participants	146 participants n=27 Participants

PRIMARY outcome

Timeframe: Up to Month 24

Percentage of patients with normal HbA1c (>=7 and <=8.5) at the end of the trial after completing the 24-month Follow-up and who had reported values in their electronic health record within 6 months of study completion.

Outcome measures

Measure	Intervention (INT) n=25 Participants (10 clinic sites and \~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM) EQUIPED-ADRD Intervention: (10 clinic sites and \~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM)	Control (CON) n=32 Participants During training the CON providers will be encouraged to do cognitive screening as well as follow the guidelines in general. Control (CON): Will use current guidelines for primary care treatment with Diabetes and Dementia
Percent of Patients Who Reach Consensus Target HBA1c	12 percentage of participants Interval -1.3 to 25.3	18.75 percentage of participants Interval 4.7 to 32.8

Adverse Events

Intervention (INT)

Serious events: 69 serious events

Other events: 0 other events

Deaths: 33 deaths

Control (CON)

Serious events: 65 serious events

Other events: 0 other events

Deaths: 32 deaths

Serious adverse events

Measure	Intervention (INT) n=191 participants at risk (10 clinic sites and \~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM) EQUIPED-ADRD Intervention: (10 clinic sites and \~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM)	Control (CON) n=164 participants at risk During training the CON providers will be encouraged to do cognitive screening as well as follow the guidelines in general. Control (CON): Will use current guidelines for primary care treatment with Diabetes and Dementia
Gastrointestinal disorders Abdominal pain	1.0% 2/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	3.0% 5/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Renal and urinary disorders Acute kidney injury	1.0% 2/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Psychiatric disorders Agitation	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	1.2% 2/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Blood and lymphatic system disorders Anemia	1.0% 2/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Metabolism and nutrition disorders Anorexia	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Vascular disorders Arterial injury	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Vascular disorders Arterial thromboembolism	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Cardiac disorders Atrial Fibrillation	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Musculoskeletal and connective tissue disorders Back Pain	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Cardiac disorders Bradycardia	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Injury, poisoning and procedural complications Bruising	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Cardiac disorders Cardiac Arrest	1.6% 3/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Investigations Cardiac troponin increased	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Cardiac disorders Chest pain -cardiac	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Musculoskeletal and connective tissue disorders Chest Wall Pain	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Gastrointestinal disorders Cholecystitis	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	1.2% 2/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Renal and urinary disorders Chronic kidney disease	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Gastrointestinal disorders Colitis	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Gastrointestinal disorders Colonic hemorrhage	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Gastrointestinal disorders Colonic Obstruction	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Gastrointestinal disorders Constipation	1.6% 3/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Respiratory, thoracic and mediastinal disorders Cough	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
General disorders Death NOS	14.7% 28/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	12.2% 20/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Metabolism and nutrition disorders Dehydration	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Psychiatric disorders Delirium	1.0% 2/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	1.2% 2/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Gastrointestinal disorders Diarrhea	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.6% 3/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
General disorders Edema limbs	1.6% 3/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Gastrointestinal disorders Enterocolitis infectious.	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	1.8% 3/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Infections and infestations Eye infection	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Injury, poisoning and procedural complications Fall	10.5% 20/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	6.7% 11/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
General disorders Fever	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Injury, poisoning and procedural complications Fracture	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Gastrointestinal disorders Gallbladder pain	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Gastrointestinal disorders Gastritis	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Gastrointestinal disorders Gastroesophageal reflux	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	1.2% 2/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Cardiac disorders Heart Failure	1.0% 2/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	3.0% 5/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Vascular disorders Hematoma	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Renal and urinary disorders Hematuria	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	1.2% 2/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Injury, poisoning and procedural complications Hip fracture	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Metabolism and nutrition disorders Hyperglycemia	1.0% 2/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	3.0% 5/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Metabolism and nutrition disorders Hypoglycemia	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	1.8% 3/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Vascular disorders Hypotension	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
General disorders Hypothermia	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications- other	1.0% 2/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Nervous system disorders Intracranial hemorrhage	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Hepatobiliary disorders Liver Failure	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	1.0% 2/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Infections and infestations Lung Infection	2.1% 4/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Cardiac disorders Myocardial Infarction	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	1.8% 3/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
General disorders Non-cardiac chest pain	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Musculoskeletal and connective tissue disorders Pain in extremity	2.1% 4/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Vascular disorders Peripheral ischemia	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Skin and subcutaneous tissue disorders Pruritus	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Renal and urinary disorders Renal colic	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	2.4% 4/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Nervous system disorders Seizure	1.0% 2/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Infections and infestations Sepsis	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Infections and infestations Skin Infection	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Skin and subcutaneous tissue disorders Skin Ulceration	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
General disorders Social circumstances	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Nervous system disorders Stroke	1.0% 2/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	1.2% 2/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Nervous system disorders Syncope	3.1% 6/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	1.8% 3/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Vascular disorders Thromboembolic event	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Gastrointestinal disorders Toothache	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	1.0% 2/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Infections and infestations Upper respiratory infection	4.2% 8/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	2.4% 4/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Renal and urinary disorders Urinary frequency	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Renal and urinary disorders Urinary retention	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Infections and infestations Urinary tract infection	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	3.0% 5/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Ear and labyrinth disorders Vertigo	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Eye disorders Vision decreased	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Gastrointestinal disorders Vomiting	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	1.2% 2/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.61% 1/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.
Infections and infestations Wound infection	0.52% 1/191 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.	0.00% 0/164 • 24 Months Adverse events were collected from notifications received from the electronic health record if the adverse event occurred within the NYU Langone Health system and the participant was enrolled in the study and from follow-up calls if the participant was reported as deceased.

Other adverse events

Adverse event data not reported

Additional Information

Mauricio Arcila-Mesa

NYU Langone Health

Phone: 646-501-4660

Email: Mauricio.arcila-mesa@nyulangone.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place