Trial Outcomes & Findings for Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (NCT NCT02037438)

NCT ID: NCT02037438

Last Updated: 2019-03-04

Results Overview

Global rating of the provider from the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CGCAHPS) compared between the two arms at end of study (12 months). The global rating instructions specify: "Using any number from 0 to 10, where 0 is the worst provider possible, and 10 is the best provider possible, what number would you use to rate this provider?"

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1836 participants

Primary outcome timeframe

12 months

Results posted on

2019-03-04

Participant Flow

Participant milestones

Participant milestones
Measure
CONV Arm
Conventional (CONV) care for the diagnosis and treatment of sleep disorders CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center
PCCM ARM
Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.
Overall Study
STARTED
920
916
Overall Study
COMPLETED
574
561
Overall Study
NOT COMPLETED
346
355

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CONV Arm
n=920 Participants
Conventional (CONV) care for the diagnosis and treatment of sleep disorders CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center
PCCM ARM
n=916 Participants
Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.
Total
n=1836 Participants
Total of all reporting groups
Age, Continuous
51.1 years
STANDARD_DEVIATION 15.60 • n=99 Participants
49.1 years
STANDARD_DEVIATION 14.98 • n=107 Participants
50.1 years
STANDARD_DEVIATION 15.32 • n=206 Participants
Sex: Female, Male
Female
396 Participants
n=99 Participants
401 Participants
n=107 Participants
797 Participants
n=206 Participants
Sex: Female, Male
Male
524 Participants
n=99 Participants
515 Participants
n=107 Participants
1039 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
89 Participants
n=99 Participants
97 Participants
n=107 Participants
186 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
814 Participants
n=99 Participants
808 Participants
n=107 Participants
1622 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
17 Participants
n=99 Participants
11 Participants
n=107 Participants
28 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
11 Participants
n=99 Participants
8 Participants
n=107 Participants
19 Participants
n=206 Participants
Race (NIH/OMB)
Asian
146 Participants
n=99 Participants
103 Participants
n=107 Participants
249 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
8 Participants
n=99 Participants
8 Participants
n=107 Participants
16 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
32 Participants
n=99 Participants
23 Participants
n=107 Participants
55 Participants
n=206 Participants
Race (NIH/OMB)
White
607 Participants
n=99 Participants
677 Participants
n=107 Participants
1284 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
105 Participants
n=99 Participants
88 Participants
n=107 Participants
193 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
11 Participants
n=99 Participants
9 Participants
n=107 Participants
20 Participants
n=206 Participants
Region of Enrollment
United States
920 participants
n=99 Participants
916 participants
n=107 Participants
1836 participants
n=206 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 546 CONV and 535 PCCM participant data were acceptable for statistical analysis for this outcome measure.

Global rating of the provider from the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CGCAHPS) compared between the two arms at end of study (12 months). The global rating instructions specify: "Using any number from 0 to 10, where 0 is the worst provider possible, and 10 is the best provider possible, what number would you use to rate this provider?"

Outcome measures

Outcome measures
Measure
CONV Arm
n=546 Participants
Conventional (CONV) care for the diagnosis and treatment of sleep disorders CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center
PCCM ARM
n=535 Participants
Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.
Change in CGCAHPS Global Rating After 12 Months
8.32 units on a scale
Standard Deviation 1.973
8.45 units on a scale
Standard Deviation 1.650

PRIMARY outcome

Timeframe: 12 months

Population: Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 540 CONV and 539 PCCM participant data were acceptable for statistical analysis for this outcome measure.

The vitality scale score of the Short Form-36 (SF-36) Version 2 Health Survey was compared at the end-of study (12 months) and was derived from the following four questions: "How much of the time during the past 4 weeks… Did you feel full of life?" "Did you have a lot of energy?" "Did you feel worn out?" "Did you feel tired?" The possible responses and point values were: all of the time (1), most of the time (2), some of the time (3), a little of the time (4), and none of the time (5). The scale is transformed to a 0-100 scale, with the lower the score indicating more disability.

Outcome measures

Outcome measures
Measure
CONV Arm
n=540 Participants
Conventional (CONV) care for the diagnosis and treatment of sleep disorders CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center
PCCM ARM
n=539 Participants
Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.
Change in SF-36 Version 2 Health Survey Vitality Score After 12 Months
48.0 units on a scale
Standard Deviation 10.84
47.1 units on a scale
Standard Deviation 11.19

SECONDARY outcome

Timeframe: 12 months

Population: Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 530 CONV and 525 PCCM participant data were acceptable for statistical analysis for this outcome measure.

Communication of provider as measured by the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CGCAHPS). This comprised "How Well Providers (or Doctors) Communicate with Patients" The ratings for the following four questions were averaged for each participant: "In the last 12 months, how often did this provider explain things in a way that was easy to understand?" "In the last 12 months, how often did this provider listen carefully to you?" "In the last 12 months, how often did this provider show respect for what you had to say?" "In the last 12 months, how often did this provider spend enough time with you?" The responses and point values were: never (1), sometimes (2), usually (3), and always (4).

Outcome measures

Outcome measures
Measure
CONV Arm
n=530 Participants
Conventional (CONV) care for the diagnosis and treatment of sleep disorders CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center
PCCM ARM
n=525 Participants
Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.
Change in CGCAHPS Provider Communication After 12 Months
3.59 units on a scale
Standard Deviation 0.655
3.64 units on a scale
Standard Deviation 0.551

SECONDARY outcome

Timeframe: 12 months

Population: Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 423 CONV and 426 PCCM participant data were acceptable for statistical analysis for this outcome measure.

Helpfulness of Provider's Use of Computers During a Visit (Effectiveness of technology as measured by the Health Information Technology item set of the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey \[CGCAHPS\]). This included composite measures of helpfulness of provider's use of computers during a visit. The ratings for the following two questions were averaged for each participant: "During your visits in the last 12 months, was this provider's use of a computer or handheld device helpful to you?" The point values for the responses were: yes, definitely (1), yes, somewhat (2), and no (3). "During your visits in the last 12 months, did this provider's use of a computer or handheld device make it harder or easier for you to talk with him or her?" The point values for the responses were: easier (1), not harder or easier (2), harder (3).

Outcome measures

Outcome measures
Measure
CONV Arm
n=423 Participants
Conventional (CONV) care for the diagnosis and treatment of sleep disorders CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center
PCCM ARM
n=426 Participants
Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.
Change in CGCAHPS Health Information Technology Measure #1 After 12 Months
2.03 units on a scale
Standard Deviation 0.378
2.06 units on a scale
Standard Deviation 0.356

SECONDARY outcome

Timeframe: 12 months

Population: Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 268 CONV and 270 PCCM participant data were acceptable for statistical analysis for this outcome measure.

Helpfulness of Provider's Website in Giving Patient Information About Patient's Care and Tests (Effectiveness of technology as measured by the Health Information Technology item set of the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey \[CGCAHPS\]). This included composite measures of helpfulness of provider's website in giving information about care and tests. The ratings for the following four questions were averaged for each participant: "In the last 12 months, how often was it easy to find these lab or other test results on the website?" "In the last 12 months, how often were these lab or other test results put on the website as soon as you needed them?" "In the last 12 months, how often were these lab or other test results presented in a way that was easy to understand?" "In the last 12 months, how often were the visit notes easy to understand?" The responses and point values were: never (1), sometimes (2), usually (3), and always (4).

Outcome measures

Outcome measures
Measure
CONV Arm
n=268 Participants
Conventional (CONV) care for the diagnosis and treatment of sleep disorders CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center
PCCM ARM
n=270 Participants
Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.
Change in CGCAHPS Health Information Technology Measure #3 After 12 Months
3.31 units on a scale
Standard Deviation 0.787
3.30 units on a scale
Standard Deviation 0.771

Adverse Events

CONV Arm

Serious events: 30 serious events
Other events: 0 other events
Deaths: 0 deaths

PCCM ARM

Serious events: 23 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
CONV Arm
n=158 participants at risk
Conventional (CONV) care for the diagnosis and treatment of sleep disorders CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center
PCCM ARM
n=172 participants at risk
Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.
Gastrointestinal disorders
Emergency Department Visits
0.63%
1/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.00%
0/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Renal and urinary disorders
Emergency Department Visits
0.63%
1/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.00%
0/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
General disorders
Emergency Department Visits
0.00%
0/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.58%
1/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Musculoskeletal and connective tissue disorders
Emergency Department Visits
0.00%
0/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.58%
1/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Nervous system disorders
Emergency Department Visits
0.63%
1/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.58%
1/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Psychiatric disorders
Emergency Department Visits
0.63%
1/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.00%
0/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Cardiac disorders
Hospital Admissions
0.63%
1/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.00%
0/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Skin and subcutaneous tissue disorders
Hospital Admissions
0.00%
0/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.58%
1/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Gastrointestinal disorders
Hospital Admissions
0.00%
0/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.58%
1/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Respiratory, thoracic and mediastinal disorders
Hospital Admissions
1.3%
2/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.00%
0/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Nervous system disorders
Hospital Admissions
1.3%
2/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.00%
0/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Psychiatric disorders
Hospital Admissions
0.63%
1/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.00%
0/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Cardiac disorders
Surgeries/Procedures
1.9%
3/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
2.3%
4/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Endocrine disorders
Surgeries/Procedures
0.63%
1/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.00%
0/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Gastrointestinal disorders
Surgeries/Procedures
0.63%
1/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
1.7%
3/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Renal and urinary disorders
Surgeries/Procedures
0.63%
1/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
1.2%
2/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Respiratory, thoracic and mediastinal disorders
Surgeries/Procedures
2.5%
4/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.58%
1/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
General disorders
Surgeries/Procedures
0.00%
0/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
1.2%
2/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Musculoskeletal and connective tissue disorders
Surgeries/Procedures
2.5%
4/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
2.3%
4/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Musculoskeletal and connective tissue disorders
Accidents
1.3%
2/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.58%
1/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Cardiac disorders
Deaths
1.3%
2/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.00%
0/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Endocrine disorders
Deaths
0.63%
1/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.00%
0/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Respiratory, thoracic and mediastinal disorders
Deaths
0.63%
1/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.00%
0/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Nervous system disorders
Deaths
0.00%
0/158 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
0.58%
1/172 • 1 year
Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Clete Kushida

Stanford University

Phone: 650-721-7560

Results disclosure agreements

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