Trial Outcomes & Findings for Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24hr Closed Loop Control (NCT NCT02679287)
NCT ID: NCT02679287
Last Updated: 2020-06-09
Results Overview
Overnight CLC achieved by USS+SAP(d) (also known at Evening-Night CLC) will be superior to SAP alone in terms of reduced incidence and risk for hypoglycemia overnight without deterioration in hemoglobin A1c. Outcomes will be stratified by Hemoglobin A1c \< 7.5% vs ≥7.5% and time of day.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
103 participants
Primary outcome timeframe
8 weeks
Results posted on
2020-06-09
Participant Flow
103 participants signed informed consent and were assessed for eligibility.10 were excluded prior to randomization (7 did not meet inclusion criteria, 2 declined to participate, 1 lost to followup). 93 participants were randomized and assigned to groups.
Participant milestones
| Measure |
Group A
Order of intervention will be 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d)
CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
1. SAP=sensor-augmented pump only
2. USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight
3. USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control
|
Group B
Order of intervention will be 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP
CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
1. SAP=sensor-augmented pump only
2. USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight
3. USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control
|
|---|---|---|
|
Period 1: Randomization-Study Session 1
STARTED
|
47
|
46
|
|
Period 1: Randomization-Study Session 1
COMPLETED
|
43
|
40
|
|
Period 1: Randomization-Study Session 1
NOT COMPLETED
|
4
|
6
|
|
Period 2
STARTED
|
43
|
40
|
|
Period 2
COMPLETED
|
40
|
40
|
|
Period 2
NOT COMPLETED
|
3
|
0
|
|
Period 3
STARTED
|
40
|
40
|
|
Period 3
COMPLETED
|
40
|
39
|
|
Period 3
NOT COMPLETED
|
0
|
1
|
|
Phase 4
STARTED
|
40
|
39
|
|
Phase 4
COMPLETED
|
40
|
39
|
|
Phase 4
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group A
Order of intervention will be 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d)
CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
1. SAP=sensor-augmented pump only
2. USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight
3. USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control
|
Group B
Order of intervention will be 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP
CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
1. SAP=sensor-augmented pump only
2. USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight
3. USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control
|
|---|---|---|
|
Period 1: Randomization-Study Session 1
Regimen not compatible with study
|
2
|
1
|
|
Period 1: Randomization-Study Session 1
Work or scheduling conflict
|
2
|
3
|
|
Period 1: Randomization-Study Session 1
Disliked mobile system
|
0
|
1
|
|
Period 1: Randomization-Study Session 1
Adverse Event prior to intervention
|
0
|
1
|
|
Period 2
Work/Scheduling Conflict
|
1
|
0
|
|
Period 2
Disliked Mobile System
|
2
|
0
|
|
Period 3
Work/Scheduling Conflict
|
0
|
1
|
Baseline Characteristics
Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24hr Closed Loop Control
Baseline characteristics by cohort
| Measure |
Group A
n=40 Participants
Order of intervention will be 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d)
CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
|
Group B
n=40 Participants
Order of intervention will be 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP
CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
42.3 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian/More than One Race
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Hemoglobin A1c
|
7.6 percent
STANDARD_DEVIATION 1.08 • n=5 Participants
|
7.24 percent
STANDARD_DEVIATION 0.97 • n=7 Participants
|
7.42 percent
STANDARD_DEVIATION 1.03 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: This primary analysis was confined to the phase of the study comparing SAP to Evening-Night CLC only when combining group A and B. Data on 24/7 CLC phase is included in secondary outcomes.
Overnight CLC achieved by USS+SAP(d) (also known at Evening-Night CLC) will be superior to SAP alone in terms of reduced incidence and risk for hypoglycemia overnight without deterioration in hemoglobin A1c. Outcomes will be stratified by Hemoglobin A1c \< 7.5% vs ≥7.5% and time of day.
Outcome measures
| Measure |
Group A and Group B Combined
n=78 Participants
Order of interventions for Group A 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d)
Order of intervention for Group B 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP
SAP=Sensor-augmented pump (study CGM+personal pump) USS+SAP(d)=Evening-Overnight CLC USS+CLC= 24/7 CLC
CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
|
Evening and Overnight Closed-Loop Control
Use of CLC evening to overnight hours for two sessions of 8 weeks
|
24/7 Closed-Loop Control
Use of CLC 24/7 for 8 weeks
|
|---|---|---|---|
|
Time <70 mg/dl by CGM
CGM Time<70 mg/dL in SAP
|
4.0 percentage of time
Standard Deviation 3.3
|
—
|
—
|
|
Time <70 mg/dl by CGM
CGM Time<70 mg/dL in Evening-Overnight CLC
|
2.2 percentage of time
Standard Deviation 1.8
|
—
|
—
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: This primary analysis was confined to the phase of the study comparing SAP to Evening-Night CLC only when combining group A and B and included the baseline HbA1c and final HbA1c. Data on HbA1c by study phase is included in secondary outcomes.
Overnight CLC achieved by USS+SAP(d) (also known as Evening-Night CLC) will be superior to SAP alone in terms of reduced incidence and risk for hypoglycemia overnight without deterioration in hemoglobin A1c. Outcomes will be stratified by Hemoglobin A1c \< 7.5% vs ≥7.5% and time of day.
Outcome measures
| Measure |
Group A and Group B Combined
n=78 Participants
Order of interventions for Group A 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d)
Order of intervention for Group B 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP
SAP=Sensor-augmented pump (study CGM+personal pump) USS+SAP(d)=Evening-Overnight CLC USS+CLC= 24/7 CLC
CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
|
Evening and Overnight Closed-Loop Control
Use of CLC evening to overnight hours for two sessions of 8 weeks
|
24/7 Closed-Loop Control
Use of CLC 24/7 for 8 weeks
|
|---|---|---|---|
|
Hemoglobin A1c
HbA1c at baseline
|
7.42 percentage of glycated hemoglobin
Standard Deviation 1.03
|
—
|
—
|
|
Hemoglobin A1c
HbA1c at end of study
|
7.11 percentage of glycated hemoglobin
Standard Deviation 0.86
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksTime in target range 70-180 mg/dL measured by CGM
Outcome measures
| Measure |
Group A and Group B Combined
n=77 Participants
Order of interventions for Group A 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d)
Order of intervention for Group B 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP
SAP=Sensor-augmented pump (study CGM+personal pump) USS+SAP(d)=Evening-Overnight CLC USS+CLC= 24/7 CLC
CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
|
Evening and Overnight Closed-Loop Control
n=77 Participants
Use of CLC evening to overnight hours for two sessions of 8 weeks
|
24/7 Closed-Loop Control
n=77 Participants
Use of CLC 24/7 for 8 weeks
|
|---|---|---|---|
|
Time Between 70-180 mg/dL by CGM
|
58.6 percentage of time
Standard Deviation 14.6
|
67.6 percentage of time
Standard Deviation 12.9
|
69.5 percentage of time
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: 8 weeksTime in hyperglycemia range \>180 mg/dL measured by CGM
Outcome measures
| Measure |
Group A and Group B Combined
n=77 Participants
Order of interventions for Group A 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d)
Order of intervention for Group B 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP
SAP=Sensor-augmented pump (study CGM+personal pump) USS+SAP(d)=Evening-Overnight CLC USS+CLC= 24/7 CLC
CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
|
Evening and Overnight Closed-Loop Control
n=77 Participants
Use of CLC evening to overnight hours for two sessions of 8 weeks
|
24/7 Closed-Loop Control
n=77 Participants
Use of CLC 24/7 for 8 weeks
|
|---|---|---|---|
|
Time >180 mg/dL by CGM
|
37.4 percentage of time
Standard Deviation 16.5
|
30.1 percentage of time
Standard Deviation 13.7
|
28.7 percentage of time
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: 8 weeksMean glucose measured by CGM overall in mmol/L
Outcome measures
| Measure |
Group A and Group B Combined
n=77 Participants
Order of interventions for Group A 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d)
Order of intervention for Group B 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP
SAP=Sensor-augmented pump (study CGM+personal pump) USS+SAP(d)=Evening-Overnight CLC USS+CLC= 24/7 CLC
CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
|
Evening and Overnight Closed-Loop Control
n=77 Participants
Use of CLC evening to overnight hours for two sessions of 8 weeks
|
24/7 Closed-Loop Control
n=77 Participants
Use of CLC 24/7 for 8 weeks
|
|---|---|---|---|
|
Mean Glucose by CGM
|
9.3 mmol/L
Standard Deviation 1.58
|
8.82 mmol/L
Standard Deviation 1.22
|
8.74 mmol/L
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: 8 weeksIndex measure of low blood glucose risk. This is an index that indicates risk of hypoglycemia with low values indicating lower risk of hypoglycemia (particularly values 1 or lower).
Outcome measures
| Measure |
Group A and Group B Combined
n=77 Participants
Order of interventions for Group A 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d)
Order of intervention for Group B 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP
SAP=Sensor-augmented pump (study CGM+personal pump) USS+SAP(d)=Evening-Overnight CLC USS+CLC= 24/7 CLC
CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
|
Evening and Overnight Closed-Loop Control
n=77 Participants
Use of CLC evening to overnight hours for two sessions of 8 weeks
|
24/7 Closed-Loop Control
n=77 Participants
Use of CLC 24/7 for 8 weeks
|
|---|---|---|---|
|
Low Blood Glucose Index (LBGI)
|
1.04 index
Standard Deviation 0.79
|
0.66 index
Standard Deviation 0.42
|
0.57 index
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: 8 weeksIndex measure of high blood glucose risk.
Outcome measures
| Measure |
Group A and Group B Combined
n=77 Participants
Order of interventions for Group A 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d)
Order of intervention for Group B 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP
SAP=Sensor-augmented pump (study CGM+personal pump) USS+SAP(d)=Evening-Overnight CLC USS+CLC= 24/7 CLC
CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
|
Evening and Overnight Closed-Loop Control
n=77 Participants
Use of CLC evening to overnight hours for two sessions of 8 weeks
|
24/7 Closed-Loop Control
n=77 Participants
Use of CLC 24/7 for 8 weeks
|
|---|---|---|---|
|
High Blood Glucose Index (HBGI)
|
8.82 index
Standard Deviation 4.61
|
6.97 index
Standard Deviation 3.52
|
6.53 index
Standard Deviation 2.86
|
SECONDARY outcome
Timeframe: 8 weeksPercentage time \<70mg/dL measured by CGM in three study phases combining Group A and B.
Outcome measures
| Measure |
Group A and Group B Combined
n=77 Participants
Order of interventions for Group A 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d)
Order of intervention for Group B 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP
SAP=Sensor-augmented pump (study CGM+personal pump) USS+SAP(d)=Evening-Overnight CLC USS+CLC= 24/7 CLC
CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
|
Evening and Overnight Closed-Loop Control
n=77 Participants
Use of CLC evening to overnight hours for two sessions of 8 weeks
|
24/7 Closed-Loop Control
n=77 Participants
Use of CLC 24/7 for 8 weeks
|
|---|---|---|---|
|
CGM <70mg/dL
|
4.0 Percentage of time
Standard Deviation 3.3
|
2.3 Percentage of time
Standard Deviation 1.7
|
1.8 Percentage of time
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 8 weeksHemoglobin A1c after each 8 weeks study session by Group A and Group B.
Outcome measures
| Measure |
Group A and Group B Combined
n=40 Participants
Order of interventions for Group A 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d)
Order of intervention for Group B 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP
SAP=Sensor-augmented pump (study CGM+personal pump) USS+SAP(d)=Evening-Overnight CLC USS+CLC= 24/7 CLC
CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
|
Evening and Overnight Closed-Loop Control
n=40 Participants
Use of CLC evening to overnight hours for two sessions of 8 weeks
|
24/7 Closed-Loop Control
Use of CLC 24/7 for 8 weeks
|
|---|---|---|---|
|
Hemoglobin A1c by Study Session
Session 3 (Gp A 24/7 CLC; Gp B evening-night CLC
|
7.13 percentage of glycated hemoglobin
Standard Deviation 0.8
|
7.06 percentage of glycated hemoglobin
Standard Deviation 0.95
|
—
|
|
Hemoglobin A1c by Study Session
Session 1 (Group A SAP; Group B evening-night CLC)
|
7.3 percentage of glycated hemoglobin
Standard Deviation 0.83
|
7.01 percentage of glycated hemoglobin
Standard Deviation 0.76
|
—
|
|
Hemoglobin A1c by Study Session
Session 2 (Gp A Evening-NIght CLC;Gp B 24/7 CLC)
|
7.12 percentage of glycated hemoglobin
Standard Deviation 0.79
|
6.95 percentage of glycated hemoglobin
Standard Deviation 0.68
|
—
|
|
Hemoglobin A1c by Study Session
Session 4 (Gp A Evening-Night CLC; Gp B SAP)
|
7.1 percentage of glycated hemoglobin
Standard Deviation 0.73
|
7.12 percentage of glycated hemoglobin
Standard Deviation 0.97
|
—
|
Adverse Events
Sensor-Augmented Pump Therapy (SAP)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Evening and Overnight Closed-Loop Control
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
24/7 Closed-Loop Control
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Other
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sensor-Augmented Pump Therapy (SAP)
n=93 participants at risk
8 week study phase for both Group A and Group B that underwent the same procedures in different orders.
|
Evening and Overnight Closed-Loop Control
n=93 participants at risk
8 week study phases (2) for both Group A and Group B that underwent the same procedures in different orders.
|
24/7 Closed-Loop Control
n=93 participants at risk
8 week study phase for both Group A and Group B that underwent the same procedures in different orders.
|
Other
n=93 participants at risk
This includes any study periods outside of other study phases listed such as screening and washout periods for both Group A and Group B that underwent the same procedures in different orders.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Appendicitis
|
1.1%
1/93 • Number of events 1 • Approximately 10-11 months.
|
0.00%
0/93 • Approximately 10-11 months.
|
0.00%
0/93 • Approximately 10-11 months.
|
0.00%
0/93 • Approximately 10-11 months.
|
|
Surgical and medical procedures
Hip Replacement Surgery
|
0.00%
0/93 • Approximately 10-11 months.
|
0.00%
0/93 • Approximately 10-11 months.
|
0.00%
0/93 • Approximately 10-11 months.
|
1.1%
1/93 • Number of events 1 • Approximately 10-11 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma with Surgical Resection
|
0.00%
0/93 • Approximately 10-11 months.
|
1.1%
1/93 • Number of events 1 • Approximately 10-11 months.
|
0.00%
0/93 • Approximately 10-11 months.
|
0.00%
0/93 • Approximately 10-11 months.
|
Other adverse events
| Measure |
Sensor-Augmented Pump Therapy (SAP)
n=93 participants at risk
8 week study phase for both Group A and Group B that underwent the same procedures in different orders.
|
Evening and Overnight Closed-Loop Control
n=93 participants at risk
8 week study phases (2) for both Group A and Group B that underwent the same procedures in different orders.
|
24/7 Closed-Loop Control
n=93 participants at risk
8 week study phase for both Group A and Group B that underwent the same procedures in different orders.
|
Other
n=93 participants at risk
This includes any study periods outside of other study phases listed such as screening and washout periods for both Group A and Group B that underwent the same procedures in different orders.
|
|---|---|---|---|---|
|
Endocrine disorders
Severe Hypoglycemia
|
0.00%
0/93 • Approximately 10-11 months.
|
3.2%
3/93 • Number of events 3 • Approximately 10-11 months.
|
0.00%
0/93 • Approximately 10-11 months.
|
2.2%
2/93 • Number of events 2 • Approximately 10-11 months.
|
|
Endocrine disorders
Hyperglycemia with ketosis not meeting diabetes ketoacidosis criteria
|
0.00%
0/93 • Approximately 10-11 months.
|
2.2%
2/93 • Number of events 2 • Approximately 10-11 months.
|
1.1%
1/93 • Number of events 1 • Approximately 10-11 months.
|
0.00%
0/93 • Approximately 10-11 months.
|
|
Musculoskeletal and connective tissue disorders
Trauma
|
1.1%
1/93 • Number of events 1 • Approximately 10-11 months.
|
1.1%
1/93 • Number of events 1 • Approximately 10-11 months.
|
1.1%
1/93 • Number of events 1 • Approximately 10-11 months.
|
1.1%
1/93 • Number of events 1 • Approximately 10-11 months.
|
|
Infections and infestations
Infections requiring medications or interventions
|
4.3%
4/93 • Number of events 4 • Approximately 10-11 months.
|
5.4%
5/93 • Number of events 5 • Approximately 10-11 months.
|
2.2%
2/93 • Number of events 2 • Approximately 10-11 months.
|
1.1%
1/93 • Number of events 1 • Approximately 10-11 months.
|
|
Musculoskeletal and connective tissue disorders
Conditions requiring steroid use
|
0.00%
0/93 • Approximately 10-11 months.
|
3.2%
3/93 • Number of events 3 • Approximately 10-11 months.
|
0.00%
0/93 • Approximately 10-11 months.
|
2.2%
2/93 • Number of events 2 • Approximately 10-11 months.
|
|
Surgical and medical procedures
Outpatient surgery or procedure
|
0.00%
0/93 • Approximately 10-11 months.
|
0.00%
0/93 • Approximately 10-11 months.
|
2.2%
2/93 • Number of events 2 • Approximately 10-11 months.
|
1.1%
1/93 • Number of events 1 • Approximately 10-11 months.
|
|
Gastrointestinal disorders
New onset Crohn's disease
|
0.00%
0/93 • Approximately 10-11 months.
|
0.00%
0/93 • Approximately 10-11 months.
|
0.00%
0/93 • Approximately 10-11 months.
|
1.1%
1/93 • Number of events 1 • Approximately 10-11 months.
|
|
Skin and subcutaneous tissue disorders
Burn
|
0.00%
0/93 • Approximately 10-11 months.
|
0.00%
0/93 • Approximately 10-11 months.
|
0.00%
0/93 • Approximately 10-11 months.
|
1.1%
1/93 • Number of events 1 • Approximately 10-11 months.
|
|
Vascular disorders
New onset edema requiring medications
|
0.00%
0/93 • Approximately 10-11 months.
|
0.00%
0/93 • Approximately 10-11 months.
|
1.1%
1/93 • Number of events 1 • Approximately 10-11 months.
|
0.00%
0/93 • Approximately 10-11 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place