Trial Outcomes & Findings for Diuretic Comparison Project (NCT NCT02185417)

Last Updated: 2024-05-22

Results Overview

Time to study primary outcome was defined as years from randomization to the first occurrence of a composite endpoint, consisting of a nonfatal cardiovascular event or non-cancer related death. Nonfatal cardiovascular events included nonfatal myocardial infarction, stroke, hospitalization for heart failure, or urgent coronary revascularization for unstable angina. For participants who had a primary outcome, time to event was determined as the earliest admission or death date. Ascertainment of study outcomes was made with the use of administrative and clinical data obtained from VA EHRs through June 1, 2022, from records of Medicare claims obtained from the Centers for Medicare and Medicaid Services through 2021, and from National Death Index records through 2019. Trial outcomes were ascertained with the use of validated EHR phenotypes and, when needed, manual adjudication. Manually adjudicated outcomes were evaluated by investigators and staff who were unaware of group assignment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

20723 participants

Primary outcome timeframe

Outcome data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants).

Results posted on

2024-05-22

Participant Flow

A total of 72 VA health care systems were enlisted in the trial. A total of 6188 primary care providers were approached for participation in the trial and 4128 (69%) consented. Patients managed by the consented provider were electronically screened for study eligibility. Centralized study recruiters telephoned potential participants and obtained oral informed consent if the patient agreed to participate (n=16595). Of these, 13523 patients were randomized (started participant flow).

After participants provided verbal informed consent, the patient's provider was sent an electronic order to sign if the provider assented to the patient undergoing study randomization. Provider participation involved agreeing to have their patients approached for trial recruitment by study staff, signing the study drug order, and managing their patient per usual care after randomization. Providers were not randomized.

Participant milestones

Participant milestones
Measure	Hydrochlorothiazide Participants remained on the existing hydrochlorothiazide treatment regimen (a daily dose of 25 or 50 mg).	Chlorthalidone Participants switched to an equivalent dose of chlorthalidone (a daily dose of 12.5 or 25 mg).	Providers Providers were enrolled in order to contact their potentially eligible patients and were not included in the results
Overall Study STARTED	6767	6756	4128
Overall Study COMPLETED	6312	6298	4128
Overall Study NOT COMPLETED	455	458	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Hydrochlorothiazide Participants remained on the existing hydrochlorothiazide treatment regimen (a daily dose of 25 or 50 mg).	Chlorthalidone Participants switched to an equivalent dose of chlorthalidone (a daily dose of 12.5 or 25 mg).	Providers Providers were enrolled in order to contact their potentially eligible patients and were not included in the results
Overall Study Death	448	446	0
Overall Study Withdrawal by Subject	7	12	0

Baseline Characteristics

Diuretic Comparison Project

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydrochlorothiazide n=6767 Participants Participants remained on the existing hydrochlorothiazide treatment regimen (a daily dose of 25 or 50 mg)	Chlorthalidone n=6756 Participants Participants switched to an equivalent dose of chlorthalidone (a daily dose of 12.5 or 25 mg)	Total n=13523 Participants Total of all reporting groups
Age, Continuous	72.5 years STANDARD_DEVIATION 5.3 • n=5 Participants	72.4 years STANDARD_DEVIATION 5.4 • n=7 Participants	72.4 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	211 Participants n=5 Participants	220 Participants n=7 Participants	431 Participants n=5 Participants
Sex: Female, Male Male	6556 Participants n=5 Participants	6536 Participants n=7 Participants	13092 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	257 Participants n=5 Participants	237 Participants n=7 Participants	494 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6268 Participants n=5 Participants	6281 Participants n=7 Participants	12549 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	242 Participants n=5 Participants	238 Participants n=7 Participants	480 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1023 Participants n=5 Participants	1004 Participants n=7 Participants	2027 Participants n=5 Participants
Race (NIH/OMB) White	5225 Participants n=5 Participants	5229 Participants n=7 Participants	10454 Participants n=5 Participants
Race (NIH/OMB) More than one race	145 Participants n=5 Participants	151 Participants n=7 Participants	296 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	361 Participants n=5 Participants	357 Participants n=7 Participants	718 Participants n=5 Participants
Region of Enrollment Puerto Rico	79 Participants n=5 Participants	77 Participants n=7 Participants	156 Participants n=5 Participants
Region of Enrollment United States	6688 Participants n=5 Participants	6679 Participants n=7 Participants	13367 Participants n=5 Participants
Age	73.5 years STANDARD_DEVIATION 5.3 • n=5 Participants	72.4 years STANDARD_DEVIATION 5.4 • n=7 Participants	72.4 years STANDARD_DEVIATION 5.3 • n=5 Participants
Body mass index	31.8 kg/m2 STANDARD_DEVIATION 5.9 • n=5 Participants	31.7 kg/m2 STANDARD_DEVIATION 5.8 • n=7 Participants	31.8 kg/m2 STANDARD_DEVIATION 5.8 • n=5 Participants
Systolic blood pressure	139 mm Hg STANDARD_DEVIATION 14 • n=5 Participants	139 mm Hg STANDARD_DEVIATION 14 • n=7 Participants	139 mm Hg STANDARD_DEVIATION 14 • n=5 Participants
Current smoker	1437 Participants n=5 Participants	1520 Participants n=7 Participants	2957 Participants n=5 Participants
Resided in rural area	3079 Participants n=5 Participants	3043 Participants n=7 Participants	6122 Participants n=5 Participants
History of diabetes	3062 Participants n=5 Participants	2967 Participants n=7 Participants	6029 Participants n=5 Participants
History of heart failure	526 Participants n=5 Participants	525 Participants n=7 Participants	1051 Participants n=5 Participants
History of myocardial infarction	258 Participants n=5 Participants	230 Participants n=7 Participants	488 Participants n=5 Participants
History of stroke	495 Participants n=5 Participants	534 Participants n=7 Participants	1029 Participants n=5 Participants
History of myocardial infarction or stroke	722 Participants n=5 Participants	733 Participants n=7 Participants	1455 Participants n=5 Participants
Estimated GFR<60 ml/min/1.73 m2	1547 Participants n=5 Participants	1550 Participants n=7 Participants	3097 Participants n=5 Participants
Receiving hydrochlorothiazide at a daily dose of 25 mg	6402 Participants n=5 Participants	6379 Participants n=7 Participants	12781 Participants n=5 Participants
Number of antihypertensive drugs prescribed	2.6 drugs STANDARD_DEVIATION 1.0 • n=5 Participants	2.6 drugs STANDARD_DEVIATION 1.1 • n=7 Participants	2.6 drugs STANDARD_DEVIATION 1.1 • n=5 Participants

PRIMARY outcome

Timeframe: Outcome data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants).

Population: Analysis of primary outcome was performed according to the intention-to-treat principle.

Outcome measures

Outcome measures
Measure	Hydrochlorothiazide n=6767 Participants Participants remained on the existing hydrochlorothiazide treatment regimen (a daily dose of 25 or 50 mg).	Chlorthalidone n=6756 Participants Participants switched to an equivalent dose of chlorthalidone (a daily dose of 12.5 or 25 mg).
Time From Randomization to Composite Primary Outcome	1.5 Years Standard Deviation 1.0	1.5 Years Standard Deviation 1.0

PRIMARY outcome

Population: Analysis of primary outcome was performed according to the intention-to-treat principle.

The primary outcome was the first occurrence of a composite endpoint consisting of a nonfatal cardiovascular event or non-cancer related death. Nonfatal cardiovascular events included nonfatal myocardial infarction, stroke, hospitalization for heart failure, or urgent coronary revascularization for unstable angina. Time to the first event was computed based on the earliest hospital admission or death dates. Ascertainment of study outcomes was made with the use of administrative and clinical data obtained from VA EHRs through June 1, 2022, from records of Medicare claims obtained from the Centers for Medicare and Medicaid Services through 2021, and from National Death Index records through 2019. Trial outcomes were ascertained with the use of validated EHR phenotypes and, when needed, manual adjudication. Manually adjudicated outcomes were evaluated by investigators and staff who were unaware of group assignment.

Outcome measures

Outcome measures
Measure	Hydrochlorothiazide n=6767 Participants Participants remained on the existing hydrochlorothiazide treatment regimen (a daily dose of 25 or 50 mg).	Chlorthalidone n=6756 Participants Participants switched to an equivalent dose of chlorthalidone (a daily dose of 12.5 or 25 mg).
Proportion of Participants Had a Composite Primary Outcome	675 Participants	702 Participants

SECONDARY outcome

Population: Analysis of secondary outcome was performed according to the intention-to-treat principle.

Secondary outcomes were the individual components of the primary outcome. Ascertainment of study outcomes was made with the use of administrative and clinical data obtained from VA EHRs through June 1, 2022, from records of Medicare claims obtained from the Centers for Medicare and Medicaid Services through 2021, and from National Death Index records through 2019. Trial outcomes were ascertained with the use of validated EHR phenotypes and, when needed, manual adjudication. Manually adjudicated outcomes were evaluated by investigators and staff who were unaware of group assignment.

Outcome measures

Outcome measures
Measure	Hydrochlorothiazide n=6767 Participants Participants remained on the existing hydrochlorothiazide treatment regimen (a daily dose of 25 or 50 mg).	Chlorthalidone n=6756 Participants Participants switched to an equivalent dose of chlorthalidone (a daily dose of 12.5 or 25 mg).
Proportion of Participants Had Nonfatal Myocardial Infarction	140 Participants	142 Participants

SECONDARY outcome

Population: Analysis of secondary outcome was performed according to the intention-to-treat principle.

Outcome measures

Outcome measures
Measure	Hydrochlorothiazide n=6767 Participants Participants remained on the existing hydrochlorothiazide treatment regimen (a daily dose of 25 or 50 mg).	Chlorthalidone n=6756 Participants Participants switched to an equivalent dose of chlorthalidone (a daily dose of 12.5 or 25 mg).
Proportion of Participants Had Nonfatal Stroke	83 Participants	83 Participants

SECONDARY outcome

Population: Analysis of secondary outcome was performed according to the intention-to-treat principle.

Outcome measures

Outcome measures
Measure	Hydrochlorothiazide n=6767 Participants Participants remained on the existing hydrochlorothiazide treatment regimen (a daily dose of 25 or 50 mg).	Chlorthalidone n=6756 Participants Participants switched to an equivalent dose of chlorthalidone (a daily dose of 12.5 or 25 mg).
Proportion of Participants Had Hospitalization for Heart Failure	232 Participants	242 Participants

SECONDARY outcome

Timeframe: Collection of outcome data were performed from randomization until participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants).

Population: Analysis of secondary outcome was performed according to the intention-to-treat principle.

Outcome measures

Outcome measures
Measure	Hydrochlorothiazide n=6767 Participants Participants remained on the existing hydrochlorothiazide treatment regimen (a daily dose of 25 or 50 mg).	Chlorthalidone n=6756 Participants Participants switched to an equivalent dose of chlorthalidone (a daily dose of 12.5 or 25 mg).
Proportion of Participants Had Unstable Angina Leading to Urgent Coronary Revascularization	13 Participants	20 Participants

SECONDARY outcome

Population: Analysis of secondary outcome was performance according to the intention-to-treat principle.

Outcome measures

Outcome measures
Measure	Hydrochlorothiazide n=6767 Participants Participants remained on the existing hydrochlorothiazide treatment regimen (a daily dose of 25 or 50 mg).	Chlorthalidone n=6756 Participants Participants switched to an equivalent dose of chlorthalidone (a daily dose of 12.5 or 25 mg).
Proportion of Participants Deceased and Not Related to Cancer	354 Participants	359 Participants

Adverse Events

Hydrochlorothiazide

Serious events: 1977 serious events

Other events: 1229 other events

Deaths: 448 deaths

Chlorthalidone

Serious events: 1990 serious events

Other events: 1397 other events

Deaths: 446 deaths

Serious adverse events

Serious adverse events
Measure	Hydrochlorothiazide n=6767 participants at risk Hydrochlorothiazide daily dose of 50 mg or 25 mg for duration of study Hydrochlorothiazide (HCTZ): Thiazide-type diuretic. Daily dose of 50 or 25 mg for duration of the study.	Chlorthalidone n=6756 participants at risk Chlorthalidone daily dose of 25 mg or 12.5 mg for duration of study Chlorthalidone: Thiazide-type diuretic. Daily dose of 25 or 12.5 mg for duration of the study.
General disorders All-cause hospitalization	27.0% 1826/6767 • Safety data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants). Adverse events (AE) were collected based on the 21 CFR 312.32, International Conference on Harmonisation (ICH) for Clinical Safety Data Management (ICH-E2A), and Cooperative Studies Program (CSP) Global standard operating procedure definitions. All-cause mortality and hospitalization were monitored and reported as serious adverse events. Expected adverse events of interest were specified in the study protocol and captured from VA electronic medical records. AEs were not collected for providers.	27.0% 1825/6756 • Safety data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants). Adverse events (AE) were collected based on the 21 CFR 312.32, International Conference on Harmonisation (ICH) for Clinical Safety Data Management (ICH-E2A), and Cooperative Studies Program (CSP) Global standard operating procedure definitions. All-cause mortality and hospitalization were monitored and reported as serious adverse events. Expected adverse events of interest were specified in the study protocol and captured from VA electronic medical records. AEs were not collected for providers.
General disorders All-cause mortality	6.6% 448/6767 • Safety data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants). Adverse events (AE) were collected based on the 21 CFR 312.32, International Conference on Harmonisation (ICH) for Clinical Safety Data Management (ICH-E2A), and Cooperative Studies Program (CSP) Global standard operating procedure definitions. All-cause mortality and hospitalization were monitored and reported as serious adverse events. Expected adverse events of interest were specified in the study protocol and captured from VA electronic medical records. AEs were not collected for providers.	6.6% 446/6756 • Safety data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants). Adverse events (AE) were collected based on the 21 CFR 312.32, International Conference on Harmonisation (ICH) for Clinical Safety Data Management (ICH-E2A), and Cooperative Studies Program (CSP) Global standard operating procedure definitions. All-cause mortality and hospitalization were monitored and reported as serious adverse events. Expected adverse events of interest were specified in the study protocol and captured from VA electronic medical records. AEs were not collected for providers.

Other adverse events

Other adverse events
Measure	Hydrochlorothiazide n=6767 participants at risk Hydrochlorothiazide daily dose of 50 mg or 25 mg for duration of study Hydrochlorothiazide (HCTZ): Thiazide-type diuretic. Daily dose of 50 or 25 mg for duration of the study.	Chlorthalidone n=6756 participants at risk Chlorthalidone daily dose of 25 mg or 12.5 mg for duration of study Chlorthalidone: Thiazide-type diuretic. Daily dose of 25 or 12.5 mg for duration of the study.
General disorders New allergic or adverse reaction to thiazide-type diuretic	0.31% 21/6767 • Safety data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants). Adverse events (AE) were collected based on the 21 CFR 312.32, International Conference on Harmonisation (ICH) for Clinical Safety Data Management (ICH-E2A), and Cooperative Studies Program (CSP) Global standard operating procedure definitions. All-cause mortality and hospitalization were monitored and reported as serious adverse events. Expected adverse events of interest were specified in the study protocol and captured from VA electronic medical records. AEs were not collected for providers.	1.6% 109/6756 • Safety data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants). Adverse events (AE) were collected based on the 21 CFR 312.32, International Conference on Harmonisation (ICH) for Clinical Safety Data Management (ICH-E2A), and Cooperative Studies Program (CSP) Global standard operating procedure definitions. All-cause mortality and hospitalization were monitored and reported as serious adverse events. Expected adverse events of interest were specified in the study protocol and captured from VA electronic medical records. AEs were not collected for providers.
General disorders Hypokalemia	4.4% 298/6767 • Safety data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants). Adverse events (AE) were collected based on the 21 CFR 312.32, International Conference on Harmonisation (ICH) for Clinical Safety Data Management (ICH-E2A), and Cooperative Studies Program (CSP) Global standard operating procedure definitions. All-cause mortality and hospitalization were monitored and reported as serious adverse events. Expected adverse events of interest were specified in the study protocol and captured from VA electronic medical records. AEs were not collected for providers.	6.0% 406/6756 • Safety data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants). Adverse events (AE) were collected based on the 21 CFR 312.32, International Conference on Harmonisation (ICH) for Clinical Safety Data Management (ICH-E2A), and Cooperative Studies Program (CSP) Global standard operating procedure definitions. All-cause mortality and hospitalization were monitored and reported as serious adverse events. Expected adverse events of interest were specified in the study protocol and captured from VA electronic medical records. AEs were not collected for providers.
General disorders Hyponatremia	5.3% 362/6767 • Safety data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants). Adverse events (AE) were collected based on the 21 CFR 312.32, International Conference on Harmonisation (ICH) for Clinical Safety Data Management (ICH-E2A), and Cooperative Studies Program (CSP) Global standard operating procedure definitions. All-cause mortality and hospitalization were monitored and reported as serious adverse events. Expected adverse events of interest were specified in the study protocol and captured from VA electronic medical records. AEs were not collected for providers.	5.4% 366/6756 • Safety data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants). Adverse events (AE) were collected based on the 21 CFR 312.32, International Conference on Harmonisation (ICH) for Clinical Safety Data Management (ICH-E2A), and Cooperative Studies Program (CSP) Global standard operating procedure definitions. All-cause mortality and hospitalization were monitored and reported as serious adverse events. Expected adverse events of interest were specified in the study protocol and captured from VA electronic medical records. AEs were not collected for providers.
General disorders Renal failure	0.86% 58/6767 • Safety data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants). Adverse events (AE) were collected based on the 21 CFR 312.32, International Conference on Harmonisation (ICH) for Clinical Safety Data Management (ICH-E2A), and Cooperative Studies Program (CSP) Global standard operating procedure definitions. All-cause mortality and hospitalization were monitored and reported as serious adverse events. Expected adverse events of interest were specified in the study protocol and captured from VA electronic medical records. AEs were not collected for providers.	0.90% 61/6756 • Safety data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants). Adverse events (AE) were collected based on the 21 CFR 312.32, International Conference on Harmonisation (ICH) for Clinical Safety Data Management (ICH-E2A), and Cooperative Studies Program (CSP) Global standard operating procedure definitions. All-cause mortality and hospitalization were monitored and reported as serious adverse events. Expected adverse events of interest were specified in the study protocol and captured from VA electronic medical records. AEs were not collected for providers.
General disorders New onset of diabetes	3.5% 240/6767 • Safety data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants). Adverse events (AE) were collected based on the 21 CFR 312.32, International Conference on Harmonisation (ICH) for Clinical Safety Data Management (ICH-E2A), and Cooperative Studies Program (CSP) Global standard operating procedure definitions. All-cause mortality and hospitalization were monitored and reported as serious adverse events. Expected adverse events of interest were specified in the study protocol and captured from VA electronic medical records. AEs were not collected for providers.	3.8% 258/6756 • Safety data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants). Adverse events (AE) were collected based on the 21 CFR 312.32, International Conference on Harmonisation (ICH) for Clinical Safety Data Management (ICH-E2A), and Cooperative Studies Program (CSP) Global standard operating procedure definitions. All-cause mortality and hospitalization were monitored and reported as serious adverse events. Expected adverse events of interest were specified in the study protocol and captured from VA electronic medical records. AEs were not collected for providers.
General disorders Acute gout episode	1.5% 100/6767 • Safety data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants). Adverse events (AE) were collected based on the 21 CFR 312.32, International Conference on Harmonisation (ICH) for Clinical Safety Data Management (ICH-E2A), and Cooperative Studies Program (CSP) Global standard operating procedure definitions. All-cause mortality and hospitalization were monitored and reported as serious adverse events. Expected adverse events of interest were specified in the study protocol and captured from VA electronic medical records. AEs were not collected for providers.	1.5% 101/6756 • Safety data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants). Adverse events (AE) were collected based on the 21 CFR 312.32, International Conference on Harmonisation (ICH) for Clinical Safety Data Management (ICH-E2A), and Cooperative Studies Program (CSP) Global standard operating procedure definitions. All-cause mortality and hospitalization were monitored and reported as serious adverse events. Expected adverse events of interest were specified in the study protocol and captured from VA electronic medical records. AEs were not collected for providers.
General disorders Hospitalization for acute kidney injury	7.6% 512/6767 • Safety data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants). Adverse events (AE) were collected based on the 21 CFR 312.32, International Conference on Harmonisation (ICH) for Clinical Safety Data Management (ICH-E2A), and Cooperative Studies Program (CSP) Global standard operating procedure definitions. All-cause mortality and hospitalization were monitored and reported as serious adverse events. Expected adverse events of interest were specified in the study protocol and captured from VA electronic medical records. AEs were not collected for providers.	7.3% 495/6756 • Safety data collection was performed from study randomization until the participants deceased, withdrawn, or reached end of study (Up to 5.4 years for the first patient enrolled and an average of 2.4 years for all participants). Adverse events (AE) were collected based on the 21 CFR 312.32, International Conference on Harmonisation (ICH) for Clinical Safety Data Management (ICH-E2A), and Cooperative Studies Program (CSP) Global standard operating procedure definitions. All-cause mortality and hospitalization were monitored and reported as serious adverse events. Expected adverse events of interest were specified in the study protocol and captured from VA electronic medical records. AEs were not collected for providers.

Additional Information

Dr. Sarah Leatherman

Boston VAHCS

Phone: 857-364-4201

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place