Trial Outcomes & Findings for A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients (NCT NCT02196038)

NCT ID: NCT02196038

Last Updated: 2021-06-24

Results Overview

The Short Physical Performance Battery is scored on a scale of 0-12, with a higher score indicating better physical function.

Recruitment status

COMPLETED

Study phase

Target enrollment

349 participants

Primary outcome timeframe

Month 3

Results posted on

2021-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Attention Control Usual care group with bi-weekly contact	Rehabilitation Intervention Individual, tailored, progressive, multi-domain physical function rehabilitation intervention
Overall Study STARTED	174	175
Overall Study COMPLETED	157	153
Overall Study NOT COMPLETED	17	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Attention Control Usual care group with bi-weekly contact	Rehabilitation Intervention Individual, tailored, progressive, multi-domain physical function rehabilitation intervention
Overall Study Death	16	21
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Attention Control n=174 Participants Usual care group with bi-weekly contact	Rehabilitation Intervention n=175 Participants Individual, tailored, progressive, multi-domain physical function rehabilitation intervention	Total n=349 Participants Total of all reporting groups
Age, Continuous	72.2 years STANDARD_DEVIATION 7.7 • n=5 Participants	73.1 years STANDARD_DEVIATION 8.5 • n=7 Participants	72.7 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	98 Participants n=5 Participants	85 Participants n=7 Participants	183 Participants n=5 Participants
Sex: Female, Male Male	76 Participants n=5 Participants	90 Participants n=7 Participants	166 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	170 Participants n=5 Participants	172 Participants n=7 Participants	342 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 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	81 Participants n=5 Participants	73 Participants n=7 Participants	154 Participants n=5 Participants
Race (NIH/OMB) White	83 Participants n=5 Participants	90 Participants n=7 Participants	173 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Short Physical Performance Battery	6.1 Score on a Scale STANDARD_DEVIATION 2.6 • n=5 Participants	6.0 Score on a Scale STANDARD_DEVIATION 2.8 • n=7 Participants	6.1 Score on a Scale STANDARD_DEVIATION 2.7 • n=5 Participants

PRIMARY outcome

Timeframe: Month 3

Population: Analysis completed on all participants alive with Month 3 SPPB obtained (n=304).

The Short Physical Performance Battery is scored on a scale of 0-12, with a higher score indicating better physical function.

Outcome measures

Outcome measures
Measure	Attention Control n=155 Participants Usual care group with bi-weekly contact	Rehabilitation Intervention n=149 Participants Individual, tailored, progressive, multi-domain physical function rehabilitation intervention
Short Physical Performance Battery (SPPB) at Month 3	6.9 score on a scale Standard Error 0.2	8.3 score on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: Month 6

Population: All participants, regardless of participation in the intervention or Month 3 follow-up were followed for all-cause rehospitalizations. Analysis completed on all participants, including deaths, except participants lost to follow-up (n=1) and participants withdrawn from study (n=1).

Number of all-cause rehospitalizations 6 months from index hospital discharge.

Outcome measures

Outcome measures
Measure	Attention Control n=173 Participants Usual care group with bi-weekly contact	Rehabilitation Intervention n=174 Participants Individual, tailored, progressive, multi-domain physical function rehabilitation intervention
All-Cause Rehospitalization	213 rehospitalizations	194 rehospitalizations

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 3

Exploratory outcome. Distance walked in 6 minutes.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 3

Exploratory outcome. Handgrip strength is measured in kilograms by a handgrip dynamometer.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 3

Exploratory outcome. Frailty is assessed by the Fried criteria consisting of 5 components: low physical activity, exhaustion, weakness, slowness, and unintentional weight loss. Presence of 3 or more Fried criteria indicates frailty, 1-2 criteria indicates pre-frailty, and 0 criteria indicates no frailty.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 3

Exploratory outcome. The KCCQ Overall Summary Summary Score is a heart failure disease-specific quality of life measure encompassing domains of physical limitation, HF symptoms, quality of life, and social limitation scored on a scale of 0-100 with higher scores indicating better health status.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 3

Exploratory outcome. The Physical Limitation Score of the KCCQ questionnaire is a subscore evaluating disease-specific physical limitation. Scores range 0-100 with a higher score indicating less physical limitation.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 3

Exploratory outcome. The SF-12 is a quality of life assessment with 2 component scores (Physical Composite Score and Mental Composite Score) ranging 0-100 with higher scores indicating better health status.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6

Exploratory outcome. The EQ-5D-5L is a quality of life tool with 5 components designed to detect health utilities: mobility, usual activities, self-care, pain/discomfort, and anxiety/depression. All components are rated on a scale of 1-5 with higher scores indicating worse health status.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 3

Exploratory outcome. The Geriatric Depression Scale is a 15-item questionnaire evaluating depressive symptoms. Scores range from 0-15 with a higher score indicating more severe depressive symptoms.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 3

Exploratory outcome. The Montreal Cognitive Assessment is a tool for assessing multiple domains of cognitive function. Scores range 0-30 with higher scores indicating better cognitive function. A score greater than or equal to 26 is considered normal cognitive function.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 1

Exploratory outcome. Number of all-cause rehospitalizations 1 month post index hospitalization discharge.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 3

Exploratory outcome. Number of all-cause rehospitalizations 3 months after discharged from index hospitalization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6

Exploratory outcome. Combined number of all-cause rehospitalizations and death 6 months after discharge from index hospitalization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6

Exploratory outcome. Number of heart failure rehospitalizations 6 months after discharge from index hospitalization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6

Exploratory outcome. Total days spent hospitalized after date of randomization.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6

Exploratory outcomes. Total days alive spent outside of hospital, observation unit, acute rehab setting, and skilled nursing facility 6 months after discharge from index hospitalization.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6

Exploratory outcomes. Number of emergency department visits after 6 months from hospital discharge

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6

Exploratory outcome. Number of observation unit stays \<24 hours 6 months after discharge from index hospitalization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6

Exploratory outcome. Number of unscheduled urgent medical visits after discharge from index hospitalization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6

Exploratory outcome. The global rank composite outcome combines non-commensurate endpoints including death, number of all-cause rehospitalizations, and month 3 SPPB into a single non-parametric outcome in a hierarchical manner with death being ranked first and SPPB being ranked last. Participants are ranked from the most adverse response (lowest rank) to the most favorable response (highest rank).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6

Exploratory outcome. Number of placements at skilled nursing facilities after discharge from index hospitalization.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6

Exploratory outcome. Physical activity assessed by accelerometry quantified in moderate-vigorous physical activity minutes per day.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 3

Exploratory outcome. The Life Orientation Test-Revised is a assessment of generalized optimism scored on a scale of 0-24 with higher scores indicating higher optimism.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6

Assess direct medical costs, direct non-medical costs, indirect patient time costs, short-term cost-analysis, long-term cost analysis, and sustainability of the intervention.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 3

Two well-accepted biomarkers of HF disease severity and prognosis, NT-proBNP and galectin-3, and increased biomarkers in older HF patients Tumor necrosis factor alpha, C-reactive protein, and interleukin-6.

Outcome measures

Outcome data not reported

Adverse Events

Attention Control

Serious events: 115 serious events

Other events: 69 other events

Deaths: 16 deaths

Rehabilitation Intervention

Serious events: 106 serious events

Other events: 60 other events

Deaths: 21 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Dalane Kitzman

Wake Forest School of Medicine

Phone: 336-716-3274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Attention Control n=174 participants at risk Usual care group with bi-weekly contact	Rehabilitation Intervention n=175 participants at risk Individual, tailored, progressive, multi-domain physical function rehabilitation intervention
Blood and lymphatic system disorders anemia	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Blood and lymphatic system disorders elevated international normalized ratio	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	1.1% 2/175 • Number of events 2 • AEs collected from date of discharge from index hospitalization through Month 6.
Blood and lymphatic system disorders epitaxis	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Cardiac disorders atrial fibrillation	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Cardiac disorders bradycardia	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	1.1% 2/175 • Number of events 2 • AEs collected from date of discharge from index hospitalization through Month 6.
Cardiac disorders chest pain	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	1.1% 2/175 • Number of events 2 • AEs collected from date of discharge from index hospitalization through Month 6.
Cardiac disorders heart failure exacerbation	4.0% 7/174 • Number of events 7 • AEs collected from date of discharge from index hospitalization through Month 6.	4.0% 7/175 • Number of events 8 • AEs collected from date of discharge from index hospitalization through Month 6.
Cardiac disorders suprventricular tachycardia	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	1.7% 3/175 • Number of events 3 • AEs collected from date of discharge from index hospitalization through Month 6.
Eye disorders sudden vision loss	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Gastrointestinal disorders diarrhea	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	1.1% 2/175 • Number of events 2 • AEs collected from date of discharge from index hospitalization through Month 6.
Gastrointestinal disorders gastrointestinal pain	1.7% 3/174 • Number of events 3 • AEs collected from date of discharge from index hospitalization through Month 6.	1.1% 2/175 • Number of events 2 • AEs collected from date of discharge from index hospitalization through Month 6.
Gastrointestinal disorders melena	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Gastrointestinal disorders nausea	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
General disorders edema	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	0.00% 0/175 • AEs collected from date of discharge from index hospitalization through Month 6.
General disorders fatigue	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	1.7% 3/175 • Number of events 3 • AEs collected from date of discharge from index hospitalization through Month 6.
General disorders non-cardiac chest pain	2.3% 4/174 • Number of events 4 • AEs collected from date of discharge from index hospitalization through Month 6.	2.9% 5/175 • Number of events 5 • AEs collected from date of discharge from index hospitalization through Month 6.
General disorders weakness	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	0.00% 0/175 • AEs collected from date of discharge from index hospitalization through Month 6.
Infections and infestations upper respiratory infection	2.3% 4/174 • Number of events 4 • AEs collected from date of discharge from index hospitalization through Month 6.	2.3% 4/175 • Number of events 4 • AEs collected from date of discharge from index hospitalization through Month 6.
Infections and infestations urinary tract infection	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	1.7% 3/175 • Number of events 4 • AEs collected from date of discharge from index hospitalization through Month 6.
Injury, poisoning and procedural complications abrasion	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Injury, poisoning and procedural complications compression fracture	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Injury, poisoning and procedural complications contusion	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Injury, poisoning and procedural complications ear injury	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	0.00% 0/175 • AEs collected from date of discharge from index hospitalization through Month 6.
Injury, poisoning and procedural complications fall (self-reported)	35.6% 62/174 • Number of events 112 • AEs collected from date of discharge from index hospitalization through Month 6.	27.4% 48/175 • Number of events 94 • AEs collected from date of discharge from index hospitalization through Month 6.
Injury, poisoning and procedural complications foot wound	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Injury, poisoning and procedural complications ICD device complications	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Injury, poisoning and procedural complications inguinal hernia	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	0.00% 0/175 • AEs collected from date of discharge from index hospitalization through Month 6.
Injury, poisoning and procedural complications post-prodecural complication	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Metabolism and nutrition disorders dehydration	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	1.1% 2/175 • Number of events 2 • AEs collected from date of discharge from index hospitalization through Month 6.
Metabolism and nutrition disorders fluid retention	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	1.7% 3/175 • Number of events 3 • AEs collected from date of discharge from index hospitalization through Month 6.
Metabolism and nutrition disorders hyperglycemia	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	1.1% 2/175 • Number of events 2 • AEs collected from date of discharge from index hospitalization through Month 6.
Metabolism and nutrition disorders hypoglycemia	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	2.3% 4/175 • Number of events 5 • AEs collected from date of discharge from index hospitalization through Month 6.
Metabolism and nutrition disorders hypokalemia	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Musculoskeletal and connective tissue disorders gout flare	1.1% 2/174 • Number of events 3 • AEs collected from date of discharge from index hospitalization through Month 6.	0.00% 0/175 • AEs collected from date of discharge from index hospitalization through Month 6.
Musculoskeletal and connective tissue disorders muscle strain	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Musculoskeletal and connective tissue disorders musculoskeletal pain	4.0% 7/174 • Number of events 7 • AEs collected from date of discharge from index hospitalization through Month 6.	5.7% 10/175 • Number of events 13 • AEs collected from date of discharge from index hospitalization through Month 6.
Nervous system disorders altered mental status	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	1.1% 2/175 • Number of events 2 • AEs collected from date of discharge from index hospitalization through Month 6.
Nervous system disorders dizziness	1.1% 2/174 • Number of events 2 • AEs collected from date of discharge from index hospitalization through Month 6.	4.6% 8/175 • Number of events 10 • AEs collected from date of discharge from index hospitalization through Month 6.
Nervous system disorders headache	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	1.1% 2/175 • Number of events 2 • AEs collected from date of discharge from index hospitalization through Month 6.
Nervous system disorders neuropathy	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Nervous system disorders seizure	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	0.00% 0/175 • AEs collected from date of discharge from index hospitalization through Month 6.
Nervous system disorders syncope	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Renal and urinary disorders acute kidney injury	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	0.00% 0/175 • AEs collected from date of discharge from index hospitalization through Month 6.
Renal and urinary disorders elevated creatinine	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Renal and urinary disorders hematuria	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	0.00% 0/175 • AEs collected from date of discharge from index hospitalization through Month 6.
Renal and urinary disorders kidney stone	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Renal and urinary disorders urinary retention	1.1% 2/174 • Number of events 2 • AEs collected from date of discharge from index hospitalization through Month 6.	0.00% 0/175 • AEs collected from date of discharge from index hospitalization through Month 6.
Respiratory, thoracic and mediastinal disorders COPD exacerbation	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	0.00% 0/175 • AEs collected from date of discharge from index hospitalization through Month 6.
Respiratory, thoracic and mediastinal disorders dyspnea	1.1% 2/174 • Number of events 2 • AEs collected from date of discharge from index hospitalization through Month 6.	2.3% 4/175 • Number of events 4 • AEs collected from date of discharge from index hospitalization through Month 6.
Skin and subcutaneous tissue disorders dermatitis	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Skin and subcutaneous tissue disorders skin lesion	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	0.57% 1/175 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.
Vascular disorders deep vein thrombosis	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	0.00% 0/175 • AEs collected from date of discharge from index hospitalization through Month 6.
Vascular disorders hypertension	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	1.7% 3/175 • Number of events 4 • AEs collected from date of discharge from index hospitalization through Month 6.
Vascular disorders hypotension	0.00% 0/174 • AEs collected from date of discharge from index hospitalization through Month 6.	1.1% 2/175 • Number of events 2 • AEs collected from date of discharge from index hospitalization through Month 6.
Vascular disorders venous stasis	0.57% 1/174 • Number of events 1 • AEs collected from date of discharge from index hospitalization through Month 6.	0.00% 0/175 • AEs collected from date of discharge from index hospitalization through Month 6.