Trial Outcomes & Findings for Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adults and Pediatrics Utilizing Lyumjev® (NCT NCT05325294)
NCT ID: NCT05325294
Last Updated: 2025-01-15
Results Overview
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
244 participants
Primary outcome timeframe
3 months
Results posted on
2025-01-15
Participant Flow
244 subjects (120 with age 7-17 and 124 with age 18-80) enrolled at the beginning, with 23 (12 with age 7-17 and 11 with age 18-80) screen failure, 10 subjects (7 with age 7-17 and 3 with age 18-80) early withdrawn prior the study period, 211 subjects (101 with age 7-17 and 110 with age 18-80) started the study and became the Intention to Treat Population.
Participant milestones
| Measure |
Subjects 7-17 Years of Age
Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.
MiniMed 780G System: MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc
|
Subjects 18-80 Years of Age
Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.
MiniMed 780G System: MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
110
|
|
Overall Study
COMPLETED
|
97
|
101
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
Reasons for withdrawal
| Measure |
Subjects 7-17 Years of Age
Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.
MiniMed 780G System: MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc
|
Subjects 18-80 Years of Age
Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.
MiniMed 780G System: MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Sponsor Request
|
0
|
2
|
Baseline Characteristics
Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adults and Pediatrics Utilizing Lyumjev®
Baseline characteristics by cohort
| Measure |
Subjects 7-17 Years of Age
n=101 Participants
Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.
MiniMed 780G System: MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc
|
Subjects 18-80 Years of Age
n=110 Participants
Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.
MiniMed 780G System: MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.0 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 14.2 • n=7 Participants
|
29.7 years
STANDARD_DEVIATION 19.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
81 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
BMI
|
22.0 kg/m^2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
28.8 kg/m^2
STANDARD_DEVIATION 5.3 • n=7 Participants
|
25.6 kg/m^2
STANDARD_DEVIATION 6.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Intention to Treat Population with available data. Two subjects aged 7-17 and two subject aged 18-80 did not collect A1C at the end of the study period, so 99 subjects aged 7-17 and 108 subjects aged 18-80 were analyzed at end of study period and the change from baseline to end of study period.
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Outcome measures
| Measure |
Subjects 7-17 Years of Age
n=99 Participants
Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.
MiniMed 780G System: MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc
|
Subjects 18-80 Years of Age
n=108 Participants
Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.
MiniMed 780G System: MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc
|
|---|---|---|
|
Primary Safety Endpoint - Change in HbA1c
|
-0.1 percentage of HbA1c
Standard Deviation 0.7
|
-0.4 percentage of HbA1c
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Last 6-7 weeks of 3 month study periodPopulation: Intention to Treat Population with available data. Three subjects aged 7-17 and eight subject aged 18-80 did not have enough SG points at the last 6 weeks of the study period, so 98 subjects aged 7-17 and 102 subjects aged 18-80 were analyzed at last 6 weeks of study period.
The mean % of time in range (TIR 70-180 mg/dL). Non-inferiority test.
Outcome measures
| Measure |
Subjects 7-17 Years of Age
n=98 Participants
Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.
MiniMed 780G System: MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc
|
Subjects 18-80 Years of Age
n=102 Participants
Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.
MiniMed 780G System: MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc
|
|---|---|---|
|
Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL)
|
68.6 percentage of Time in Range (TIR 70-180
Standard Deviation 10.3
|
77.6 percentage of Time in Range (TIR 70-180
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Last 6-7 weeks of 3 month study periodPopulation: Intention to Treat Population with available data. Three subjects aged 7-17 and eight subject aged 18-80 did not have enough SG points at the last 6 weeks of the study period, so 98 subjects aged 7-17 and 102 subjects aged 18-80 were analyzed at last 6 weeks of study period.
The mean % of time in hypoglycemia (\< 54 mg/dL). Non-inferiority test.
Outcome measures
| Measure |
Subjects 7-17 Years of Age
n=98 Participants
Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.
MiniMed 780G System: MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc
|
Subjects 18-80 Years of Age
n=102 Participants
Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.
MiniMed 780G System: MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc
|
|---|---|---|
|
Secondary Effectiveness Endpoint 1 - Percent of Time in Hypoglycemia (< 54 mg/dL)
|
0.4 percentage of Time in Hypoglycemia (< 54
Standard Deviation 0.5
|
0.2 percentage of Time in Hypoglycemia (< 54
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Last 6-7 weeks of 3 month study periodPopulation: Intention to Treat Population with available data. Three subjects aged 7-17 and eight subject aged 18-80 did not have enough SG points at the last 6 weeks of the study period, so 98 subjects aged 7-17 and 102 subjects aged 18-80 were analyzed at last 6 weeks of study period.
The mean % of time in range (TIR 70-180 mg/dL). Superiority test.
Outcome measures
| Measure |
Subjects 7-17 Years of Age
n=98 Participants
Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.
MiniMed 780G System: MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc
|
Subjects 18-80 Years of Age
n=102 Participants
Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.
MiniMed 780G System: MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc
|
|---|---|---|
|
Secondary Effectiveness Endpoint 2 - Percent of Time in Range (TIR 70-180 mg/dL)
|
68.6 percentage of Time in Range (TIR 70-180
Standard Deviation 10.3
|
77.6 percentage of Time in Range (TIR 70-180
Standard Deviation 9.6
|
Adverse Events
Subjects 7-17 Years of Age Study Period
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Subjects 18-80 Years of Age Study Period
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subjects 7-17 Years of Age Study Period
n=101 participants at risk
Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.
MiniMed 780G System: MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc
|
Subjects 18-80 Years of Age Study Period
n=110 participants at risk
Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.
MiniMed 780G System: MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Endocrine disorders
Hypothyroidism
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Eye disorders
Binocular eye movement disorder
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Eye disorders
Eye swelling
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Gastrointestinal disorders
Abdominal pain
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Gastrointestinal disorders
Gastritis
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Gastrointestinal disorders
Nausea
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Gastrointestinal disorders
Vomiting
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Fatigue
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Infusion site bruising
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Infusion site reaction
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Infusion site swelling
|
0.99%
1/101 • Number of events 2 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Medical device site dermatitis
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Medical device site haemorrhage
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Medical device site irritation
|
2.0%
2/101 • Number of events 3 • 3-month Study Period
Only Adverse Events during the study period were posted
|
1.8%
2/110 • Number of events 2 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Medical device site papule
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Medical device site reaction
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Pain
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Physical deconditioning
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Pyrexia
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Abscess limb
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
COVID-19
|
3.0%
3/101 • Number of events 3 • 3-month Study Period
Only Adverse Events during the study period were posted
|
8.2%
9/110 • Number of events 9 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Ear infection
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Gastroenteritis
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Gastroenteritis viral
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Influenza
|
4.0%
4/101 • Number of events 4 • 3-month Study Period
Only Adverse Events during the study period were posted
|
1.8%
2/110 • Number of events 2 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Infusion site cellulitis
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Laryngitis
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Medical device site infection
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
5/101 • Number of events 6 • 3-month Study Period
Only Adverse Events during the study period were posted
|
1.8%
2/110 • Number of events 2 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Oral herpes
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Otitis media
|
2.0%
2/101 • Number of events 2 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Sinusitis
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
3.6%
4/110 • Number of events 4 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Streptococcal infection
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Tooth infection
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Upper respiratory tract infection
|
9.9%
10/101 • Number of events 11 • 3-month Study Period
Only Adverse Events during the study period were posted
|
4.5%
5/110 • Number of events 6 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Viral infection
|
2.0%
2/101 • Number of events 2 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
9.9%
10/101 • Number of events 14 • 3-month Study Period
Only Adverse Events during the study period were posted
|
10.0%
11/110 • Number of events 18 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.9%
8/101 • Number of events 8 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Metabolism and nutrition disorders
Ketosis
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Nervous system disorders
Headache
|
3.0%
3/101 • Number of events 3 • 3-month Study Period
Only Adverse Events during the study period were posted
|
1.8%
2/110 • Number of events 2 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/101 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.91%
1/110 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Nervous system disorders
Migraine
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Psychiatric disorders
Anxiety
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
2/101 • Number of events 2 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.99%
1/101 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/110 • 3-month Study Period
Only Adverse Events during the study period were posted
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60