Trial Outcomes & Findings for Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics (NCT NCT04436822)
NCT ID: NCT04436822
Last Updated: 2023-06-02
Results Overview
Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™\*) reference value (within 20 mg/dL \[1.1 mmol/L\] when sensor values \< 80 mg/dL) \[4.4 mmol/L\]) by age groups and DS5 insertion locations. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. Zero calibration sensor algorithm applied to raw sensor data.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
317 participants
Primary outcome timeframe
7 days (170 hours)
Results posted on
2023-06-02
Participant Flow
317 subjects (175 adult subjects, 141 pediatric subjects, and 1 age-unknown subject) consented and enrolled in the overall study. Of them, 7 subjects were screening failure and 310 subjects (172 adult subjects and 138 pediatric subjects) participated in the study.
Participant milestones
| Measure |
Adult Subjects (Age 18-80) Wearing DS5
Adult subjects (age 18-80) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing
|
Pediatric Subjects (Age 2-17) Wearing DS5
Pediatric subjects (age 2-17) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing
|
|---|---|---|
|
Overall Study
STARTED
|
172
|
138
|
|
Overall Study
COMPLETED
|
160
|
132
|
|
Overall Study
NOT COMPLETED
|
12
|
6
|
Reasons for withdrawal
| Measure |
Adult Subjects (Age 18-80) Wearing DS5
Adult subjects (age 18-80) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing
|
Pediatric Subjects (Age 2-17) Wearing DS5
Pediatric subjects (age 2-17) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Sponsor request
|
1
|
0
|
|
Overall Study
Withdrawal by parent/guardian
|
0
|
3
|
|
Overall Study
Unsuccessful procedure
|
0
|
1
|
|
Overall Study
Withdrawal due to Covid-19
|
8
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
The sponsor was not able to provide the investigational product
|
0
|
1
|
Baseline Characteristics
Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics
Baseline characteristics by cohort
| Measure |
Adult Subjects (Age 18-80) Wearing DS5
n=172 Participants
Adult subjects (age 18-80) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing
|
Pediatric Subjects (Age 2-17) Wearing DS5
n=138 Participants
Pediatric subjects (age 2-17) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 16.8 • n=5 Participants
|
10.5 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
30.3 years
STANDARD_DEVIATION 22.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
98 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
54 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
121 participants
n=5 Participants
|
117 participants
n=7 Participants
|
238 participants
n=5 Participants
|
|
Region of Enrollment
China
|
51 participants
n=5 Participants
|
21 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
BMI (kg/m2)
|
28.7 kg/m^2
STANDARD_DEVIATION 6.4 • n=5 Participants
|
19.8 kg/m^2
STANDARD_DEVIATION 4.2 • n=7 Participants
|
24.8 kg/m^2
STANDARD_DEVIATION 7.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days (170 hours)Population: Subjects with at least 1 sensor-YSI (or sensor-SMBG for subjects 2-6 years) paired point during the sensor wear
Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™\*) reference value (within 20 mg/dL \[1.1 mmol/L\] when sensor values \< 80 mg/dL) \[4.4 mmol/L\]) by age groups and DS5 insertion locations. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. Zero calibration sensor algorithm applied to raw sensor data.
Outcome measures
| Measure |
Adult Subjects (Age 18-80) Wearing DS5 on the Arm
n=155 Participants
Adult subjects (age 18-80) wearing DS5 on the arm over 7 days: Continuous Glucose Monitoring and frequent sample testing. Zero calibration sensor algorithm applied to raw sensor data.
|
Pediatric Subjects (Age 2-17) Wearing DS5 on the Arm
n=127 Participants
Pediatric subjects (age 2-17) wearing DS5 on the arm over 7 days: Continuous Glucose Monitoring and frequent sample testing. Zero calibration sensor algorithm applied to raw sensor data.
|
Pediatric Subjects (Age 2-17) Wearing DS5 on the Buttock
n=118 Participants
Pediatric subjects (age 2-17) wearing DS5 on the buttock over 7 days: Continuous Glucose Monitoring and frequent sample testing. Zero calibration sensor algorithm applied to raw sensor data.
|
|---|---|---|---|
|
Percentage of Readings Within 20% Agreement
|
88.9 percentage of readings
Interval 87.1 to 90.7
|
87.5 percentage of readings
Interval 85.4 to 89.7
|
87.9 percentage of readings
Interval 85.8 to 89.9
|
Adverse Events
Adult Subjects (Age 18-80) Wearing DS5
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Pediatric Subjects (Age 2-17) Wearing DS5
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adult Subjects (Age 18-80) Wearing DS5
n=172 participants at risk
Adult subjects (age 18-80) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing
|
Pediatric Subjects (Age 2-17) Wearing DS5
n=138 participants at risk
Pediatric subjects (age 2-17) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing
|
|---|---|---|
|
Renal and urinary disorders
BILATERAL HYDRONEPHROSIS
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
Other adverse events
| Measure |
Adult Subjects (Age 18-80) Wearing DS5
n=172 participants at risk
Adult subjects (age 18-80) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing
|
Pediatric Subjects (Age 2-17) Wearing DS5
n=138 participants at risk
Pediatric subjects (age 2-17) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing
|
|---|---|---|
|
Metabolism and nutrition disorders
Alcoholic ketoacidosis
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Vascular disorders
Arteriosclerosis
|
1.2%
2/172 • Number of events 2 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Endocrine disorders
Autoimmune thyroiditis
|
1.2%
2/172 • Number of events 2 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
2.9%
5/172 • Number of events 5 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Investigations
Blood potassium decreased
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Nervous system disorders
Carotid arteriosclerosis
|
4.1%
7/172 • Number of events 7 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.72%
1/138 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Metabolism and nutrition disorders
Diabetic ketosis
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Renal and urinary disorders
Diabetic nephropathy
|
1.2%
2/172 • Number of events 2 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Nervous system disorders
Diabetic neuropathy
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Eye disorders
Dry eye
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
3.5%
6/172 • Number of events 6 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Hepatobiliary disorders
Gallbladder polyp
|
1.7%
3/172 • Number of events 3 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Giant cell tumour of tendon sheath
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Musculoskeletal and connective tissue disorders
Growth retardation
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.72%
1/138 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Renal and urinary disorders
Haematuria
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.72%
1/138 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Hepatobiliary disorders
Hepatic cyst
|
1.7%
3/172 • Number of events 3 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Hepatobiliary disorders
Hepatic mass
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Hepatobiliary disorders
Hepatic steatosis
|
2.9%
5/172 • Number of events 5 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.72%
1/138 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
1.4%
2/138 • Number of events 2 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.7%
3/172 • Number of events 3 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.72%
1/138 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Infections and infestations
Infusion site infection
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.72%
1/138 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
General disorders
Infusion site pain
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
1.4%
2/138 • Number of events 2 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Metabolism and nutrition disorders
Ketosis
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Cardiac disorders
Left atrial enlargement
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
General disorders
Medical device site bruise
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.72%
1/138 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
General disorders
Medical device site pain
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.72%
1/138 • Number of events 4 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
General disorders
Medical device site rash
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.72%
1/138 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.72%
1/138 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.72%
1/138 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.7%
3/172 • Number of events 3 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Hepatobiliary disorders
Non-alcoholic fatty liver
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Infections and infestations
Otitis media
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
1.4%
2/138 • Number of events 2 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
2.3%
4/172 • Number of events 4 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Infections and infestations
Pharyngitis
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Psychiatric disorders
Poor quality sleep
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Infections and infestations
Postoperative wound infection
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Reproductive system and breast disorders
Prostatic calcification
|
1.7%
3/172 • Number of events 3 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Renal and urinary disorders
Proteinuria
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
2.3%
4/172 • Number of events 4 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
General disorders
Pyrexia
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.72%
1/138 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.72%
1/138 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Renal and urinary disorders
Renal cyst
|
2.9%
5/172 • Number of events 5 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.72%
1/138 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.72%
1/138 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Infections and infestations
Skin infection
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Endocrine disorders
Thyroid mass
|
2.9%
5/172 • Number of events 5 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/172 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
3.6%
5/138 • Number of events 5 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Infections and infestations
Urinary tract infection
|
1.2%
2/172 • Number of events 2 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.72%
1/138 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Ear and labyrinth disorders
Vertigo
|
0.58%
1/172 • Number of events 1 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Investigations
Vitamin D decreased
|
1.2%
2/172 • Number of events 2 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.3%
4/172 • Number of events 4 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
0.00%
0/138 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
|
Gastrointestinal disorders
Vomiting
|
0.58%
1/172 • Number of events 2 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
2.9%
4/138 • Number of events 4 • Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60