Trial Outcomes & Findings for Safety and Effectiveness of the MiniMed™ 780G System With DS5 CGM (NCT NCT05714059)
NCT ID: NCT05714059
Last Updated: 2025-02-17
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
250 participants
Primary outcome timeframe
3 months
Results posted on
2025-02-17
Participant Flow
250 subjects (125 with age 7-17 and 125 with age 18-80) enrolled at the beginning, with 20 (7 with age7-17 and 13 with age 18-80) screen failure, 8 subjects (6 with age 7-17 and 2 with age 18-80) early withdrawn, 222 subjects (112 with age 7-17 and 110 with age 18-80) were left as the Intention to Treat Population and started the study.
Participant milestones
| Measure |
Subjects 7-17 Years of Age
Subjects 7-17 years of age wearing MiniMed™ 780G System With DS5 CGM
|
Subjects 18-80 Years of Age
Subjects 18-80 years of age wearing MiniMed™ 780G System With DS5 CGM
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
110
|
|
Overall Study
COMPLETED
|
107
|
105
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Subjects 7-17 Years of Age
Subjects 7-17 years of age wearing MiniMed™ 780G System With DS5 CGM
|
Subjects 18-80 Years of Age
Subjects 18-80 years of age wearing MiniMed™ 780G System With DS5 CGM
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
WITHDRAWAL BY PARENT/GUARDIAN
|
3
|
0
|
|
Overall Study
TECHNICAL PROBLEMS
|
0
|
1
|
Baseline Characteristics
Safety and Effectiveness of the MiniMed™ 780G System With DS5 CGM
Baseline characteristics by cohort
| Measure |
Subjects 7-17 Years of Age
n=112 Participants
Subjects 7-17 years of age wearing MiniMed™ 780G System With DS5 CGM
|
Subjects 18-80 Years of Age
n=110 Participants
Subjects 18-80 years of age wearing MiniMed™ 780G System With DS5 CGM
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.3 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 15.8 • n=7 Participants
|
29.8 years
STANDARD_DEVIATION 20.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
206 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
95 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
BMI
|
21.9 kg/m^2
STANDARD_DEVIATION 4.8 • n=5 Participants
|
28.8 kg/m^2
STANDARD_DEVIATION 5.9 • n=7 Participants
|
25.3 kg/m^2
STANDARD_DEVIATION 6.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Intention to Treat Population" to "Intention to Treat Population and HbA1c at exit were collected. HbA1c at exit were collected from 217 subjects in intention to treat population (111 subjects with age 7-17 and 106 subjects with age 18-80)
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=111 Participants
Subjects 7-17 years of age wearing MiniMed™ 780G System With DS5 CGM
|
Subjects 18-80 Years of Age
n=106 Participants
Subjects 18-80 years of age wearing MiniMed™ 780G System With DS5 CGM
|
|---|---|---|
|
Primary Safety Endpoint - Change in HbA1c
|
-0.4 percentage of HbA1c
Standard Deviation 0.8
|
-0.7 percentage of HbA1c
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Last 6-7 weeks of 3 month study periodPopulation: Intention to Treat Population and Time in range metric were available from last 6-7 weeks of 3 month study period. Time in range metrics from last 6-7 weeks of 3 month study period were available from 216 subjects in intention to treat population (109 subjects with age 7-17 and 107 subjects with age 18-80)
Age 18-80: The mean % of time in range (TIR 70-180 mg/dL). Non-inferiority test.
Outcome measures
| Measure |
Subjects 7-17 Years of Age
n=109 Participants
Subjects 7-17 years of age wearing MiniMed™ 780G System With DS5 CGM
|
Subjects 18-80 Years of Age
n=107 Participants
Subjects 18-80 years of age wearing MiniMed™ 780G System With DS5 CGM
|
|---|---|---|
|
Primary Effectiveness Endpoint for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL)
|
71.4 percentage of Time in Range (TIR 70-180)
Standard Deviation 9.9
|
80.2 percentage of Time in Range (TIR 70-180)
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Last 6-7 weeks of 3 month study periodPopulation: Intention to Treat Population and Time in hypoglycemia metrics were available from last 6-7 weeks of 3 month study period. Time in hypoglycemia metrics from last 6-7 weeks of 3 month study period were available from 216 subjects in intention to treat population (109 subjects with age 7-17 and 107 subjects with age 18-80)
The mean % of time in hypoglycemia (\< 54 mg/dL) . Non-inferiority test.
Outcome measures
| Measure |
Subjects 7-17 Years of Age
n=109 Participants
Subjects 7-17 years of age wearing MiniMed™ 780G System With DS5 CGM
|
Subjects 18-80 Years of Age
n=107 Participants
Subjects 18-80 years of age wearing MiniMed™ 780G System With DS5 CGM
|
|---|---|---|
|
Secondary Effectiveness Endpoint 1 - Percent of Time in Hypoglycemia (< 54 mg/dL)
|
0.4 percentage of Time in Hypoglycemia(< 54)
Standard Deviation 0.3
|
0.2 percentage of Time in Hypoglycemia(< 54)
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Last 6-7 weeks of 3 month study periodPopulation: Intention to Treat Population and Time in range metric were available from last 6-7 weeks of 3 month study period. Time in range metrics from last 6-7 weeks of 3 month study period were available from 216 subjects in intention to treat population (109 subjects with age 7-17 and 107 subjects with age 18-80)
The mean % of time in range (TIR 70-180 mg/dL ).Superiority test.
Outcome measures
| Measure |
Subjects 7-17 Years of Age
n=109 Participants
Subjects 7-17 years of age wearing MiniMed™ 780G System With DS5 CGM
|
Subjects 18-80 Years of Age
n=107 Participants
Subjects 18-80 years of age wearing MiniMed™ 780G System With DS5 CGM
|
|---|---|---|
|
Secondary Effectiveness Endpoint 2 - Percent of Time in Range (TIR 70-180 mg/dL)
|
71.4 percentage of Time in Range (70-180)
Standard Deviation 9.9
|
80.2 percentage of Time in Range (70-180)
Standard Deviation 8.1
|
Adverse Events
Subjects 7-17 Years of Age
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Subjects 18-80 Years of Age
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subjects 7-17 Years of Age
n=112 participants at risk
Subjects 7-17 years of age wearing MiniMed™ 780G System With DS5 CGM
|
Subjects 18-80 Years of Age
n=110 participants at risk
Subjects 18-80 years of age wearing MiniMed™ 780G System With DS5 CGM
|
|---|---|---|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
1.8%
2/110 • Number of events 2 • 3 month Study period
Only the adverse event in the study period are posted here.
|
Other adverse events
| Measure |
Subjects 7-17 Years of Age
n=112 participants at risk
Subjects 7-17 years of age wearing MiniMed™ 780G System With DS5 CGM
|
Subjects 18-80 Years of Age
n=110 participants at risk
Subjects 18-80 years of age wearing MiniMed™ 780G System With DS5 CGM
|
|---|---|---|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Eye disorders
Retinopathy
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
2/112 • Number of events 2 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Gastrointestinal disorders
Oral pain
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
General disorders
Illness
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
General disorders
Influenza like illness
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
General disorders
Infusion site dermatitis
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
General disorders
Infusion site haemorrhage
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
General disorders
Infusion site pain
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
General disorders
Infusion site rash
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
General disorders
Infusion site reaction
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
General disorders
Medical device site dermatitis
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
General disorders
Medical device site haemorrhage
|
1.8%
2/112 • Number of events 2 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
General disorders
Medical device site pain
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
General disorders
Medical device site pruritus
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 2 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
General disorders
Medical device site reaction
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
1.8%
2/110 • Number of events 2 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
General disorders
Pyrexia
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
COVID-19
|
1.8%
2/112 • Number of events 3 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Cystitis
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Folliculitis
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Fungal foot infection
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Gastroenteritis
|
1.8%
2/112 • Number of events 2 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Impetigo
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Infusion site infection
|
3.6%
4/112 • Number of events 12 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Localised infection
|
1.8%
2/112 • Number of events 2 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Medical device site cellulitis
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Medical device site infection
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
2/112 • Number of events 2 • 3 month Study period
Only the adverse event in the study period are posted here.
|
4.5%
5/110 • Number of events 5 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
1.8%
2/110 • Number of events 2 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Otitis media
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Purulent discharge
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Skin bacterial infection
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.9%
10/112 • Number of events 10 • 3 month Study period
Only the adverse event in the study period are posted here.
|
1.8%
2/110 • Number of events 2 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Urinary tract infection
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Vaginal infection
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Viral infection
|
2.7%
3/112 • Number of events 3 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Infections and infestations
Viral rhinitis
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.8%
2/112 • Number of events 2 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Investigations
Blood potassium increased
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Investigations
Vitamin B12 increased
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.4%
6/112 • Number of events 8 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Musculoskeletal and connective tissue disorders
Greater trochanteric pain syndrome
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Nervous system disorders
Dizziness
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
2.7%
3/110 • Number of events 3 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Psychiatric disorders
Depression
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Psychiatric disorders
Dysphemia
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
1.8%
2/110 • Number of events 2 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.89%
1/112 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.00%
0/110 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Surgical and medical procedures
Vasectomy
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Vascular disorders
Haematoma
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/112 • 3 month Study period
Only the adverse event in the study period are posted here.
|
0.91%
1/110 • Number of events 1 • 3 month Study period
Only the adverse event in the study period are posted here.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI agrees not to publish until 12 months from trial completion or until sponsor publishes multi-center results, whichever occurs first. In either case, sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period more than 60 days but less than or equal to 180 days from the date that the communication is submitted to sponsor for review. Sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER