Trial Outcomes & Findings for Treatment of Depressed Chronic Obstructive Pulmonary Disease Patients (NCT NCT00151372)

Last Updated: 2010-01-11

Results Overview

The Composite Antidepressant Score scale (CAD) describes the adequacy of an antidepressant's dosage. Scores range from 0-4 with 0, 1, and 2 signifying subthreshold or non-adequate therapeutic dosages while 3 and 4 signify a therapeutic/adequate dosage. The best value is 4 while the worst value is 0.

Recruitment status

COMPLETED

Study phase

Target enrollment

141 participants

Primary outcome timeframe

28 Weeks

Results posted on

2010-01-11

Participant Flow

All subjects were recruited from the Inpatient Pulmonary Rehabilitation Units of the Burke Rehabilitation Hospital and Helen Hayes Rehabilitation Hospital. Recruitment began in March 2002 and ended in January 2008.

Participant milestones

Participant milestones
Measure	Treatment Adherence Intervention In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.	Enhanced Care In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
Overall Study STARTED	67	74
Overall Study COMPLETED	38	45
Overall Study NOT COMPLETED	29	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Adherence Intervention In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.	Enhanced Care In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
Overall Study Death	12	11
Overall Study Lost to Follow-up	5	5
Overall Study Too sick medically to continue	5	6
Overall Study Withdrawal by Subject	7	7

Baseline Characteristics

Treatment of Depressed Chronic Obstructive Pulmonary Disease Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Adherence Intervention n=67 Participants In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.	Enhanced Care n=74 Participants In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.	Total n=141 Participants Total of all reporting groups
Age Continuous	71.24 years STANDARD_DEVIATION 8.54 • n=5 Participants	71.5 years STANDARD_DEVIATION 8.0 • n=7 Participants	71.4 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	51 Participants n=7 Participants	93 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment United States	67 participants n=5 Participants	74 participants n=7 Participants	141 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 Weeks

Population: Analysis was conducted on subjects actively participating in the study at the 28-week assessment. The number corresponds to "Completed" in the "Participant Flow" section.

Outcome measures

Outcome measures
Measure	Treatment Adherence Intervention n=38 Participants In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.	Enhanced Care n=45 Participants In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
Composite Antidepressant Score Scale (CAD) Non-Adequate Antidepressant Treatment	9 Participants	20 Participants
Composite Antidepressant Score Scale (CAD) Adequate Antidepressant Treatment	29 Participants 7.4	25 Participants 9.3

SECONDARY outcome

Timeframe: 28 Weeks

Population: Analysis was conducted on subjects actively participating in the study at the 28-week assessment. The number corresponds to "Completed" in the "Participant Flow" section.

The 17-item Hamilton Depression Rating Scale (HDRS) measures the severity of a depressive episode: the higher the score, the more severe the depression. The Best value is 0 and the Worst value is 52.

Outcome measures

Outcome measures
Measure	Treatment Adherence Intervention n=38 Participants In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.	Enhanced Care n=45 Participants In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
Hamilton Depression Rating Scale	9.2 points on a scale Standard Deviation 5.7	12.4 points on a scale Standard Deviation 6.0

Adverse Events

Treatment Adherence Intervention

Serious events: 38 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced Care

Serious events: 46 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

George S. Alexopoulos, M.D.

Weill Cornell Medical College

Phone: 914-997-5767

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Treatment Adherence Intervention n=67 participants at risk In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.	Enhanced Care n=74 participants at risk In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
Injury, poisoning and procedural complications Accidental Medication Overdose	0.00% 0/67 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	1.4% 1/74 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Cardiac disorders Atrial Fibrilation	0.00% 0/67 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	1.4% 1/74 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Musculoskeletal and connective tissue disorders Back surgery	1.5% 1/67 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	0.00% 0/74 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Cardiac disorders Bradycardia	1.5% 1/67 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	0.00% 0/74 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
General disorders Brain cancer	0.00% 0/67 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	1.4% 1/74 • Number of events 2 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Infections and infestations Cellulitis	0.00% 0/67 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	1.4% 1/74 • Number of events 2 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
General disorders Cervical cancer	0.00% 0/67 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	1.4% 1/74 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Gastrointestinal disorders Colitis	1.5% 1/67 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	0.00% 0/74 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Cardiac disorders Congestive Heart Failure	3.0% 2/67 • Number of events 2 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	1.4% 1/74 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Gastrointestinal disorders Constipation	1.5% 1/67 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	0.00% 0/74 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
General disorders Debility	0.00% 0/67 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	1.4% 1/74 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
General disorders Dehydration	0.00% 0/67 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	1.4% 1/74 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Renal and urinary disorders Edema	1.5% 1/67 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	2.7% 2/74 • Number of events 2 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Respiratory, thoracic and mediastinal disorders Exacerbation of chronic obstructive pulmonary disease	37.3% 25/67 • Number of events 36 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	45.9% 34/74 • Number of events 38 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Injury, poisoning and procedural complications Fall	3.0% 2/67 • Number of events 2 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	0.00% 0/74 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Musculoskeletal and connective tissue disorders Fracture	1.5% 1/67 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	1.4% 1/74 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Cardiac disorders Heart attack	1.5% 1/67 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	0.00% 0/74 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Cardiac disorders Heart surgery	4.5% 3/67 • Number of events 4 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	0.00% 0/74 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
General disorders High potassium levels	1.5% 1/67 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	0.00% 0/74 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Musculoskeletal and connective tissue disorders Hip pain	0.00% 0/67 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	1.4% 1/74 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Psychiatric disorders Inpatient psychiatric hospitalization	3.0% 2/67 • Number of events 2 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	1.4% 1/74 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
General disorders Loss of consciousness/fainting	1.5% 1/67 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	2.7% 2/74 • Number of events 2 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Respiratory, thoracic and mediastinal disorders Lung Cancer	3.0% 2/67 • Number of events 2 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	1.4% 1/74 • Number of events 2 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Respiratory, thoracic and mediastinal disorders Pneumonia	6.0% 4/67 • Number of events 5 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	6.8% 5/74 • Number of events 5 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Renal and urinary disorders Renal Failure	3.0% 2/67 • Number of events 2 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	0.00% 0/74 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Infections and infestations Staph infection	0.00% 0/67 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	4.1% 3/74 • Number of events 4 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Gastrointestinal disorders Stomach pain	0.00% 0/67 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	1.4% 1/74 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Surgical and medical procedures Total knee replacement	0.00% 0/67 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	1.4% 1/74 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
General disorders Unknown case of death	1.5% 1/67 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	2.7% 2/74 • Number of events 2 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.
Renal and urinary disorders Urinary tract infection	0.00% 0/67 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.	1.4% 1/74 • Number of events 1 • 1 Year. The 14, 28, and 52 week assessments recorded any serious adverse event that had taken place since the previous assessment. This research study only tracked serious adverse events which included any incident which required that the subject seek medical attention (for example, specially scheduled physician's appointment, emergency room visit, and/or inpatient hospitalization) or death. We did not track adverse events: "0" in the adverse event section reflects this.