Trial Outcomes & Findings for Evaluating the User Performance and Experience of Nucleus Pen vs. Commercially Available Pen Needle (NCT NCT03267264)
NCT ID: NCT03267264
Last Updated: 2019-07-16
Results Overview
This is a combined endpoint for all study subjects. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
248 participants
Primary outcome timeframe
30 Days
Results posted on
2019-07-16
Participant Flow
Participant milestones
| Measure |
Group 1
BD Nano™ vs Nucleus: Subjects will be randomized to
1. Nucleus pen needle for the first 15-day period, or current pen needle (BD Nano™) for the second 15-day period or
2. subject's current pen needle (BD Nano™) for the first 15-day period, Nucleus pen needle for the second 15-day period
|
Group 2
NovoFine® vs Nucleus: Subjects will be randomized to
1. Nucleus pen needle for the first 15-day period, or current pen needle (NovoFine®) for the second 15-day period or
2. subject's current pen needle (NovoFine®) for the first 15-day period, Nucleus pen needle for the second 15-day period
|
Group 3
NovoTwist®/NovoFine® Plus vs Nucleus: Subjects will be randomized to
1. Nucleus pen needle for the first 15-day period, or current pen needle (NovoTwist®/NovoFine Plus®) for the second 15-day period or
2. subject's current pen needle (NovoTwis®t/NovoFine® Plus) for the first 15-day period, Nucleus pen needle for the second 15-day period
|
Group 4
Other Commercially Available Pen Needles (MHC Easy Touch, Simple Diagnostics Comfor EZ) vs Nucleus: Subjects will be randomized to
1. Nucleus pen needle for the first 15-day period, or current pen needle (Other Commercially Available Pen Needles) for the second 15-day period or
2. subject's current pen needle (Other Commercially Available Pen Needles) for the first 15-day period, Nucleus pen needle for the second 15-day period
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
66
|
49
|
68
|
65
|
|
Overall Study
Sequence A(Nucleus)
|
34
|
25
|
33
|
33
|
|
Overall Study
Sequence B(Comparator)
|
32
|
24
|
33
|
32
|
|
Overall Study
COMPLETED
|
65
|
49
|
66
|
61
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
4
|
Reasons for withdrawal
| Measure |
Group 1
BD Nano™ vs Nucleus: Subjects will be randomized to
1. Nucleus pen needle for the first 15-day period, or current pen needle (BD Nano™) for the second 15-day period or
2. subject's current pen needle (BD Nano™) for the first 15-day period, Nucleus pen needle for the second 15-day period
|
Group 2
NovoFine® vs Nucleus: Subjects will be randomized to
1. Nucleus pen needle for the first 15-day period, or current pen needle (NovoFine®) for the second 15-day period or
2. subject's current pen needle (NovoFine®) for the first 15-day period, Nucleus pen needle for the second 15-day period
|
Group 3
NovoTwist®/NovoFine® Plus vs Nucleus: Subjects will be randomized to
1. Nucleus pen needle for the first 15-day period, or current pen needle (NovoTwist®/NovoFine Plus®) for the second 15-day period or
2. subject's current pen needle (NovoTwis®t/NovoFine® Plus) for the first 15-day period, Nucleus pen needle for the second 15-day period
|
Group 4
Other Commercially Available Pen Needles (MHC Easy Touch, Simple Diagnostics Comfor EZ) vs Nucleus: Subjects will be randomized to
1. Nucleus pen needle for the first 15-day period, or current pen needle (Other Commercially Available Pen Needles) for the second 15-day period or
2. subject's current pen needle (Other Commercially Available Pen Needles) for the first 15-day period, Nucleus pen needle for the second 15-day period
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
4
|
Baseline Characteristics
Evaluating the User Performance and Experience of Nucleus Pen vs. Commercially Available Pen Needle
Baseline characteristics by cohort
| Measure |
Group 1
n=66 Participants
BD Nano™ vs Nucleus: Subjects will be randomized to
1. Nucleus pen needle for the first 15-day period, or current pen needle (BD Nano™) for the second 15-day period or
2. subject's current pen needle (BD Nano™) for the first 15-day period, Nucleus pen needle for the second 15-day period
|
Group 2
n=49 Participants
NovoFine® vs Nucleus: Subjects will be randomized to
1. Nucleus pen needle for the first 15-day period, or current pen needle (NovoFine®) for the second 15-day period or
2. subject's current pen needle (NovoFine®) for the first 15-day period, Nucleus pen needle for the second 15-day period
|
Group 3
n=68 Participants
NovoTwist®/NovoFine® Plus vs Nucleus: Subjects will be randomized to
1. Nucleus pen needle for the first 15-day period, or current pen needle (NovoTwist®/NovoFine Plus®) for the second 15-day period or
2. subject's current pen needle (NovoTwist®/NovoFine® Plus) for the first 15-day period, Nucleus pen needle for the second 15-day period
|
Group 4
n=65 Participants
Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus: Subjects will be randomized to
1. Nucleus pen needle for the first 15-day period, or current pen needle (Other Commercially Available Pen Needles) for the second 15-day period or
2. subject's current pen needle (Other Commercially Available Pen Needles) for the first 15-day period, Nucleus pen needle for the second 15-day period
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
55.4 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
55.2 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
55.6 years
STANDARD_DEVIATION 12.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
237 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: Per-protocol population; note that one VAS data point was missing.
This is a combined endpoint for all study subjects. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).
Outcome measures
| Measure |
Combined Groups
n=225 Participants
Nucleus vs all groups combined
|
Group 2
NovoFine® vs Nucleus
|
Group 3
NovoTwist®/NovoFine® Plus vs Nucleus
|
Group 4
Other Commercially Available Pen Needles
|
|---|---|---|---|---|
|
Overall User Preference -Combined Groups
|
17.5 mm
Interval 10.3 to 24.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Per-protocol population; note that one VAS data point was missing
This endpoint analyzes data for individual groups. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).
Outcome measures
| Measure |
Combined Groups
n=60 Participants
Nucleus vs all groups combined
|
Group 2
n=42 Participants
NovoFine® vs Nucleus
|
Group 3
n=64 Participants
NovoTwist®/NovoFine® Plus vs Nucleus
|
Group 4
n=59 Participants
Other Commercially Available Pen Needles
|
|---|---|---|---|---|
|
Overall User Preference - Each Comparator Group
|
30.5 mm
Interval 16.8 to 44.3
|
20.6 mm
Interval 4.1 to 37.1
|
6.2 mm
Interval -7.2 to 19.5
|
12.8 mm
Interval -1.1 to 26.7
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Per-protocol population
This is a combined endpoint for all study subjects. User experience is assessed through a series of questions reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle). Questions include the subject's perception of: Overall Comfort, Anxiety Associated with a Needle Stick Injury, Injection Pain, and Ease of Use.
Outcome measures
| Measure |
Combined Groups
n=226 Participants
Nucleus vs all groups combined
|
Group 2
NovoFine® vs Nucleus
|
Group 3
NovoTwist®/NovoFine® Plus vs Nucleus
|
Group 4
Other Commercially Available Pen Needles
|
|---|---|---|---|---|
|
User Experience - All Study Groups Combined
Overall Comfort
|
18.0 mm
Interval 11.3 to 24.7
|
—
|
—
|
—
|
|
User Experience - All Study Groups Combined
Anxiety Associated with a Needle Stick Injury
|
15.9 mm
Interval 9.9 to 21.8
|
—
|
—
|
—
|
|
User Experience - All Study Groups Combined
Injection Pain
|
15.5 mm
Interval 8.9 to 22.1
|
—
|
—
|
—
|
|
User Experience - All Study Groups Combined
Ease of Use
|
19.7 mm
Interval 13.8 to 25.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Per-protocol population
This endpoint analyzes data for individual groups. User experience is assessed through a series of questions reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle). Questions include the subject's perception of: Overall Comfort, Anxiety Associated with a Needle Stick Injury, Injection Pain, and Ease of Use.
Outcome measures
| Measure |
Combined Groups
n=60 Participants
Nucleus vs all groups combined
|
Group 2
n=43 Participants
NovoFine® vs Nucleus
|
Group 3
n=64 Participants
NovoTwist®/NovoFine® Plus vs Nucleus
|
Group 4
n=59 Participants
Other Commercially Available Pen Needles
|
|---|---|---|---|---|
|
User Experience - Each Individual Study Group
Overall Comfort
|
27.8 mm
Interval 14.9 to 40.7
|
20.7 mm
Interval 5.3 to 36.1
|
8.4 mm
Interval -4.0 to 20.9
|
15.1 mm
Interval 2.1 to 28.1
|
|
User Experience - Each Individual Study Group
Anxiety Associated with a Needle Stick Injury
|
20.2 mm
Interval 8.9 to 31.6
|
19.4 mm
Interval 6.0 to 32.8
|
12.9 mm
Interval 1.9 to 23.8
|
11.0 mm
Interval -0.5 to 22.4
|
|
User Experience - Each Individual Study Group
Injection Pain
|
16.1 mm
Interval 3.4 to 28.8
|
18.6 mm
Interval 3.6 to 33.7
|
7.0 mm
Interval -5.3 to 19.4
|
20.2 mm
Interval 7.4 to 33.1
|
|
User Experience - Each Individual Study Group
Ease of Use
|
30.7 mm
Interval 19.3 to 42.1
|
18.4 mm
Interval 4.9 to 31.9
|
17.7 mm
Interval 6.7 to 28.8
|
12.0 mm
Interval 0.5 to 23.5
|
Adverse Events
Nucleus
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
BD Nano
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
NovoFine®
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
NovoTwist®/NovoFine®
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Other Commercially Available Pen Needles (Unifine® Pentips®/M
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nucleus
n=241 participants at risk
This arm contains every subject in the study. Because every subject regardless of group recieved Nucleus
|
BD Nano
n=65 participants at risk
This arm contains only those subjects that recieve BD Nano, included in results section described in group 1.
|
NovoFine®
n=49 participants at risk
This arm contains only those subjects that recieved NovoFine®, included in results section described in group 2.
|
NovoTwist®/NovoFine®
n=66 participants at risk
This arm contains only those subjects that recieved NovoTwist®/NovoFine®, included in results section described in group 3.
|
Other Commercially Available Pen Needles (Unifine® Pentips®/M
n=61 participants at risk
This arm contains only those subjects that recieved Other Commercial Pen Needles, included in results section described in group 4.
|
|---|---|---|---|---|---|
|
Surgical and medical procedures
Broken Right Ankle
|
0.41%
1/241 • Number of events 1 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/65 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/49 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/66 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/61 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
|
Infections and infestations
Infection of L Hand Laceration
|
0.00%
0/241 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/65 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
2.0%
1/49 • Number of events 1 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/66 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/61 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
0.00%
0/241 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/65 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/49 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/66 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
1.6%
1/61 • Number of events 1 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
Other adverse events
| Measure |
Nucleus
n=241 participants at risk
This arm contains every subject in the study. Because every subject regardless of group recieved Nucleus
|
BD Nano
n=65 participants at risk
This arm contains only those subjects that recieve BD Nano, included in results section described in group 1.
|
NovoFine®
n=49 participants at risk
This arm contains only those subjects that recieved NovoFine®, included in results section described in group 2.
|
NovoTwist®/NovoFine®
n=66 participants at risk
This arm contains only those subjects that recieved NovoTwist®/NovoFine®, included in results section described in group 3.
|
Other Commercially Available Pen Needles (Unifine® Pentips®/M
n=61 participants at risk
This arm contains only those subjects that recieved Other Commercial Pen Needles, included in results section described in group 4.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Bleeding
|
8.7%
21/241 • Number of events 21 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
6.2%
4/65 • Number of events 4 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
2.0%
1/49 • Number of events 1 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
3.0%
2/66 • Number of events 2 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
3.3%
2/61 • Number of events 2 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
|
Injury, poisoning and procedural complications
Bruising
|
5.8%
14/241 • Number of events 14 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
1.5%
1/65 • Number of events 1 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/49 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/66 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
3.3%
2/61 • Number of events 2 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
|
Injury, poisoning and procedural complications
Swelling/Pain at injection site
|
4.1%
10/241 • Number of events 10 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/65 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/49 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/66 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
1.6%
1/61 • Number of events 1 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/241 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/65 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
2.0%
1/49 • Number of events 1 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
3.0%
2/66 • Number of events 2 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/61 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
|
Infections and infestations
Abcess under chin
|
0.41%
1/241 • Number of events 1 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/65 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/49 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/66 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/61 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Common Cold
|
0.41%
1/241 • Number of events 1 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/65 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/49 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/66 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/61 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.41%
1/241 • Number of events 1 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/65 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/49 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/66 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/61 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/241 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/65 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
2.0%
1/49 • Number of events 1 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/66 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/61 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
|
Surgical and medical procedures
L hand Laceration
|
0.00%
0/241 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/65 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
2.0%
1/49 • Number of events 1 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/66 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/61 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Illness
|
0.41%
1/241 • Number of events 1 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/65 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/49 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/66 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/61 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Stomach Ulcer
|
0.41%
1/241 • Number of events 1 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/65 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/49 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/66 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/61 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
|
Endocrine disorders
Worsening of Type 2 Diabetes
|
0.41%
1/241 • Number of events 1 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/65 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/49 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/66 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
0.00%
0/61 • Adverse Events were collected over 6 week period.
Adverse Events and Serious Adverse Events did not differ from clinicaltrials.gov definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place