Trial Outcomes & Findings for Bronchitis and Emphysema Advice and Training to Reduce Hospitalization (NCT NCT00395083)

NCT ID: NCT00395083

Last Updated: 2014-09-15

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 426 participants
• Primary outcome timeframe: From randomization until date of first hospitalization for COPD, assessed up to 26 months
• Results posted on: 2014-09-15

Participant Flow

The pilot study began in July 2006, and trial recruitment began in January 2007 with 6 sites, later expanding to 20. Recruitment ended early in March 2009 due to DMC recommendations.

Participant milestones

Measure	Usual Care Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.	Comprehensive Care Management Program The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care. COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs.
Overall Study STARTED	217	209
Overall Study COMPLETED	207	201
Overall Study NOT COMPLETED	10	8

Reasons for withdrawal

Measure	Usual Care Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.	Comprehensive Care Management Program The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care. COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs.
Overall Study Withdrawal by Subject	6	5
Overall Study Developed another disease	4	3

Baseline Characteristics

Bronchitis and Emphysema Advice and Training to Reduce Hospitalization

Baseline characteristics by cohort

Measure	Usual Care n=217 Participants Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.	Comprehensive Care Management Program n=209 Participants The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care. COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs.	Total n=426 Participants Total of all reporting groups
Age, Continuous	65.8 years STANDARD_DEVIATION 8.2 • n=5 Participants	66.2 years STANDARD_DEVIATION 8.4 • n=7 Participants	66.0 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	209 Participants n=5 Participants	204 Participants n=7 Participants	413 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	24 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) White	191 Participants n=5 Participants	181 Participants n=7 Participants	372 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	209 Participants n=5 Participants	207 Participants n=7 Participants	416 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

PRIMARY outcome

Timeframe: From randomization until date of first hospitalization for COPD, assessed up to 26 months

Outcome measures

Measure	Usual Care n=217 Participants Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.	Comprehensive Care Management Program n=209 Participants The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care. COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs.
Hospitalization-free Survival - Time to Event	0.45 years Interval 0.36 to 0.53	0.46 years Interval 0.39 to 0.54

PRIMARY outcome

Timeframe: 26 months

Outcome measures

Measure	Usual Care n=217 Participants Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.	Comprehensive Care Management Program n=209 Participants The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care. COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs.
Hazard Ratio for First COPD Hospitalization Subjects with COPD Hospitalization	34 participants	36 participants
Hazard Ratio for First COPD Hospitalization Subjects without COPD Hospitalization	183 participants	173 participants

SECONDARY outcome

Timeframe: 26 months

Outcome measures

Measure	Usual Care n=217 Participants Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.	Comprehensive Care Management Program n=209 Participants The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care. COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs.
Hazard Ratio for All-Cause Mortality All-Cause Death	10 participants	28 participants
Hazard Ratio for All-Cause Mortality Alive	207 participants	181 participants

SECONDARY outcome

Timeframe: From randomization until death, assessed up to 26 months

Outcome measures

Measure	Usual Care n=217 Participants Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.	Comprehensive Care Management Program n=209 Participants The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care. COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs.
Time to All-Cause Death	0.51 years Interval 0.43 to 0.79	0.49 years Interval 0.4 to 0.61

Adverse Events

Usual Care

Serious events: 98 serious events

Other events: 0 other events

Deaths: 0 deaths

Comprehensive Care Management Program

Serious events: 91 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Usual Care n=217 participants at risk Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.	Comprehensive Care Management Program n=209 participants at risk The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care. COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs.
Blood and lymphatic system disorders Anaemia	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.96% 2/209 • Number of events 2 Non-serious adverse events were not collected for this study.
Cardiac disorders Angina pectoris	0.92% 2/217 • Number of events 2 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Cardiac disorders Angina unstable	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Cardiac disorders Arteriosclerosis coronary artery	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Cardiac disorders Atrial fibrillation	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.96% 2/209 • Number of events 5 Non-serious adverse events were not collected for this study.
Cardiac disorders Atrial flutter	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Cardiac disorders Cardiac failure congestive	0.92% 2/217 • Number of events 2 Non-serious adverse events were not collected for this study.	3.8% 8/209 • Number of events 12 Non-serious adverse events were not collected for this study.
Cardiac disorders Myocardial infarction	1.8% 4/217 • Number of events 4 Non-serious adverse events were not collected for this study.	1.4% 3/209 • Number of events 3 Non-serious adverse events were not collected for this study.
Cardiac disorders Myocardial ischaemia	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Cardiac disorders Tachycardia	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Gastrointestinal disorders Colitis ischaemic	0.92% 2/217 • Number of events 2 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Gastrointestinal disorders Diarrhoea	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Gastrointestinal disorders Duodenal ulcer	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Gastrointestinal disorders Gastritis erosive	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	1.4% 3/209 • Number of events 4 Non-serious adverse events were not collected for this study.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Gastrointestinal disorders Intestinal infarction	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Gastrointestinal disorders Pneumatosis intestinalis	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Gastrointestinal disorders Volvulus	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
General disorders Adverse drug reaction	0.92% 2/217 • Number of events 2 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
General disorders Chest discomfort	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
General disorders Chest pain	3.2% 7/217 • Number of events 7 Non-serious adverse events were not collected for this study.	1.9% 4/209 • Number of events 4 Non-serious adverse events were not collected for this study.
General disorders Death	1.4% 3/217 • Number of events 3 Non-serious adverse events were not collected for this study.	2.9% 6/209 • Number of events 6 Non-serious adverse events were not collected for this study.
General disorders Fatigue	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
General disorders Hernia	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Gastrointestinal disorders Non-cardiac chest pain	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
General disorders Oedema peripheral	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Hepatobiliary disorders Cholangitis	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Hepatobiliary disorders Liver injury	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Infections and infestations Bacteraemia	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Infections and infestations Cellulitis	0.92% 2/217 • Number of events 2 Non-serious adverse events were not collected for this study.	0.96% 2/209 • Number of events 3 Non-serious adverse events were not collected for this study.
Infections and infestations Clostridium difficile colitis	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.96% 2/209 • Number of events 2 Non-serious adverse events were not collected for this study.
Infections and infestations Diverticulitis	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Infections and infestations Escherichia bacteraemia	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Infections and infestations Infective exacerbation of chronic obstructive	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Infections and infestations Lung infection pseudomonal	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Infections and infestations Pneumonia	7.8% 17/217 • Number of events 19 Non-serious adverse events were not collected for this study.	8.1% 17/209 • Number of events 21 Non-serious adverse events were not collected for this study.
Infections and infestations Prostate infection	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Infections and infestations Rhinitis	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Infections and infestations Urinary tract infection	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Infections and infestations Urinary tract infection staphylococal	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Injury, poisoning and procedural complications Fall	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	1.4% 3/209 • Number of events 4 Non-serious adverse events were not collected for this study.
Injury, poisoning and procedural complications Overdose	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Injury, poisoning and procedural complications Post procedural complication	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Injury, poisoning and procedural complications Procedural complication	1.4% 3/217 • Number of events 3 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Injury, poisoning and procedural complications Road traffic accident	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Injury, poisoning and procedural complications Splenic rupture	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Investigations Biopsy lung	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Investigations Blood glucose increased	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Investigations Tuberculin test positive	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Metabolism and nutrition disorders Dehydration	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Metabolism and nutrition disorders Diabetes mellitus	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Metabolism and nutrition disorders Fluid overload	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 2 Non-serious adverse events were not collected for this study.
Metabolism and nutrition disorders Gout	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Nervous system disorders Aphasia	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Nervous system disorders Carotid artery stenosis	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Psychiatric disorders Aggression	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Psychiatric disorders Anxiety disorder	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Psychiatric disorders Confusional state	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Psychiatric disorders Depression	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Psychiatric disorders Drug abuse	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Psychiatric disorders Mental status changes	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Psychiatric disorders Panic attack	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Renal and urinary disorders Bladder mass	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Renal and urinary disorders Pollakiuria	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Renal and urinary disorders Renal failure acute	0.92% 2/217 • Number of events 2 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Renal and urinary disorders Urinary retention	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Reproductive system and breast disorders Erectile dysfunction	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.92% 2/217 • Number of events 3 Non-serious adverse events were not collected for this study.	1.4% 3/209 • Number of events 3 Non-serious adverse events were not collected for this study.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	24.4% 53/217 • Number of events 84 Non-serious adverse events were not collected for this study.	20.1% 42/209 • Number of events 65 Non-serious adverse events were not collected for this study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.8% 4/217 • Number of events 5 Non-serious adverse events were not collected for this study.	1.9% 4/209 • Number of events 5 Non-serious adverse events were not collected for this study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.96% 2/209 • Number of events 2 Non-serious adverse events were not collected for this study.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.96% 2/209 • Number of events 2 Non-serious adverse events were not collected for this study.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.3% 5/217 • Number of events 5 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Social circumstances Physical assault	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 2 Non-serious adverse events were not collected for this study.
Surgical and medical procedures Angioplasty	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Surgical and medical procedures Bladder operation	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Surgical and medical procedures Cardiac pacemaker insertion	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Surgical and medical procedures Carotid endarterectomy	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Surgical and medical procedures Colectomy	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Surgical and medical procedures Hospitalisation	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Surgical and medical procedures Implantable defibrillator insertion	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Surgical and medical procedures Knee arthroplasty	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Surgical and medical procedures Palliative care	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Surgical and medical procedures Preoperative care	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Vascular disorders Aortic aneurysm	0.00% 0/217 Non-serious adverse events were not collected for this study.	1.4% 3/209 • Number of events 3 Non-serious adverse events were not collected for this study.
Vascular disorders Aortic aneurysm rupture	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Vascular disorders Deep vein thrombosis	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Vascular disorders Hypertension	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Vascular disorders Peripheral vascular disorder	0.46% 1/217 • Number of events 2 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Vascular disorders Subclavian artery stenosis	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Cardiac disorders Cardiac arrest	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Cardiac disorders Cardiac disorder	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Cardiac disorders Cardiac failure	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Gastrointestinal disorders Inguinal hernia	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Gastrointestinal disorders Vomiting	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
General disorders Asthenia	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Hepatobiliary disorders Hepatitis alcoholic	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Infections and infestations Gastroenteritis viral	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Infections and infestations Gastrointestinal infection	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Injury, poisoning and procedural complications Wound complication	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Investigations International normalised ratio increased	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.96% 2/209 • Number of events 2 Non-serious adverse events were not collected for this study.
Nervous system disorders Syncope	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Psychiatric disorders Alocholism	0.46% 1/217 • Number of events 2 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Surgical and medical procedures Surgery	0.46% 1/217 • Number of events 1 Non-serious adverse events were not collected for this study.	0.00% 0/209 Non-serious adverse events were not collected for this study.
Vascular disorders Orthostatic hypotension	0.00% 0/217 Non-serious adverse events were not collected for this study.	0.48% 1/209 • Number of events 1 Non-serious adverse events were not collected for this study.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sarah Leatherman

VA Boston Healthcare System - MAVERIC

Phone: 857-364-4220

Email: sarah.leatherman@va.gov

Results disclosure agreements

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