Trial Outcomes & Findings for In-Home Study With MiniMed™ 780G Pump Automated Control in Type 2-Evaluation of the AHCL System in Adults With Insulin-requiring Type 2 Diabetes (NCT NCT05238142)
NCT ID: NCT05238142
Last Updated: 2026-04-16
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
574 participants
Primary outcome timeframe
Baseline and end of 3-month study period
Results posted on
2026-04-16
Participant Flow
574 subjects (165 from Phase 1 and 409 from Phase 2) enrolled at the beginning, with 193 (58 from Phase 1 and 135 from Phase 2) screen failures, 50 subjects (12 from Phase 1 and 38 from Phase 2) early withdrawn, 331 subjects (95 from Phase 1 and 236 from Phase 2 ) were left as the Intention to Treat Population and started the study period.
Participant milestones
| Measure |
Phase 1
Phase 1 studied the MiniMed™ 780G insulin pump with Guardian 4 Sensor. Only the results for the Intention-to-Treat (ITT) population are included.
|
Phase 2
Phase 2 studied the MiniMed™ 780G BLE 2.0 insulin pump with the disposable sensor DS5. Only the results for the Intention-to-Treat (ITT) population are included.
|
|---|---|---|
|
Phase 1 Study Period
STARTED
|
95
|
0
|
|
Phase 1 Study Period
COMPLETED
|
89
|
0
|
|
Phase 1 Study Period
NOT COMPLETED
|
6
|
0
|
|
Phase 1 Continuation Period
STARTED
|
66
|
0
|
|
Phase 1 Continuation Period
COMPLETED
|
56
|
0
|
|
Phase 1 Continuation Period
NOT COMPLETED
|
10
|
0
|
|
Phase 2 Study Period-Transition + Naive
STARTED
|
66
|
236
|
|
Phase 2 Study Period-Transition + Naive
COMPLETED
|
64
|
228
|
|
Phase 2 Study Period-Transition + Naive
NOT COMPLETED
|
2
|
8
|
Reasons for withdrawal
| Measure |
Phase 1
Phase 1 studied the MiniMed™ 780G insulin pump with Guardian 4 Sensor. Only the results for the Intention-to-Treat (ITT) population are included.
|
Phase 2
Phase 2 studied the MiniMed™ 780G BLE 2.0 insulin pump with the disposable sensor DS5. Only the results for the Intention-to-Treat (ITT) population are included.
|
|---|---|---|
|
Phase 1 Study Period
Adverse Event
|
2
|
0
|
|
Phase 1 Study Period
Protocol Violation
|
2
|
0
|
|
Phase 1 Study Period
Withdrawal by Subject
|
2
|
0
|
|
Phase 1 Continuation Period
Adverse Event
|
2
|
0
|
|
Phase 1 Continuation Period
Subjects exited during Phase 1 Continuation Period and declined to join Phase 2.
|
3
|
0
|
|
Phase 1 Continuation Period
Protocol Violation
|
4
|
0
|
|
Phase 1 Continuation Period
Withdrawal by Subject
|
1
|
0
|
|
Phase 2 Study Period-Transition + Naive
Adverse Event
|
0
|
1
|
|
Phase 2 Study Period-Transition + Naive
Death
|
0
|
1
|
|
Phase 2 Study Period-Transition + Naive
Lost to Follow-up
|
1
|
3
|
|
Phase 2 Study Period-Transition + Naive
Patient was discharged from clinic and was not able to come back onsite for visits.
|
0
|
1
|
|
Phase 2 Study Period-Transition + Naive
Protocol Violation
|
1
|
1
|
|
Phase 2 Study Period-Transition + Naive
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
In-Home Study With MiniMed™ 780G Pump Automated Control in Type 2-Evaluation of the AHCL System in Adults With Insulin-requiring Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Phase 1
n=95 Participants
Phase 1 studied the MiniMed™ 780G insulin pump with Guardian 4 Sensor. Only the results for the Intention-to-Treat (ITT) population are included.
|
Phase 2 Naive
n=236 Participants
Phase 2 studied the MiniMed™ 780G BLE 2.0 insulin pump with the disposable sensor DS5. Only the results for the Intention-to-Treat (ITT) population are included.
|
Total
n=331 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 10.8 • n=193 Participants
|
59.7 years
STANDARD_DEVIATION 11.2 • n=193 Participants
|
59.9 years
STANDARD_DEVIATION 11.1 • n=386 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=193 Participants
|
138 Participants
n=193 Participants
|
185 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=193 Participants
|
98 Participants
n=193 Participants
|
146 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=193 Participants
|
40 Participants
n=193 Participants
|
45 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
89 Participants
n=193 Participants
|
194 Participants
n=193 Participants
|
283 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
3 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=193 Participants
|
17 Participants
n=193 Participants
|
19 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=193 Participants
|
30 Participants
n=193 Participants
|
46 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=193 Participants
|
174 Participants
n=193 Participants
|
250 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
4 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
9 Participants
n=193 Participants
|
9 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: Baseline and end of 3-month study periodPopulation: Study period: 95 subjects in Phase 1. 88 subjects have available measurements.
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Outcome measures
| Measure |
Phase 1
n=88 Participants
Phase 1 studied the MiniMed™ 780G insulin pump with Guardian 4 Sensor. Only the results for the Intention-to-Treat (ITT) population are included.
|
|---|---|
|
Primary Safety Endpoint - Change in HbA1c Phase 1
|
-0.71 Percentage of HbA1c
Interval -0.9 to -0.51
|
PRIMARY outcome
Timeframe: Last 6 weeks of 3 month study periodPopulation: Study period: 95 subjects in Phase 1. 91 subjects have available measurements.
The mean percent of time in range (TIR 70-180 mg/dL). Non-inferiority test.
Outcome measures
| Measure |
Phase 1
n=91 Participants
Phase 1 studied the MiniMed™ 780G insulin pump with Guardian 4 Sensor. Only the results for the Intention-to-Treat (ITT) population are included.
|
|---|---|
|
Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL) Phase 1
|
80.9 Percentage of TIR
Interval 78.4 to 83.1
|
PRIMARY outcome
Timeframe: Baseline and end of 3-month study periodPopulation: Study period: 66 subjects in Phase 2 Transition. 65 subjects have available measurements.
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Outcome measures
| Measure |
Phase 1
n=65 Participants
Phase 1 studied the MiniMed™ 780G insulin pump with Guardian 4 Sensor. Only the results for the Intention-to-Treat (ITT) population are included.
|
|---|---|
|
Primary Safety Endpoint - Change in HbA1c Phase 2 Transition
|
-0.26 Percentage of HbA1c
Interval -0.37 to -0.15
|
PRIMARY outcome
Timeframe: Baseline and end of 3-month study periodPopulation: Study period: 236 subjects in Phase 2 Naive. 229 subjects have available measurements.
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Outcome measures
| Measure |
Phase 1
n=229 Participants
Phase 1 studied the MiniMed™ 780G insulin pump with Guardian 4 Sensor. Only the results for the Intention-to-Treat (ITT) population are included.
|
|---|---|
|
Primary Safety Endpoint - Change in HbA1c Phase 2 Naive
|
-0.7 Percentage of HbA1c
Interval -0.8 to -0.6
|
PRIMARY outcome
Timeframe: Last 6 weeks of 3 month study periodPopulation: Study period: 302 subjects in Phase 2 Transition + Naive. 298 subjects have available measurements.
The mean percent of time in range (TIR 70-180 mg/dL). Non-inferiority test.
Outcome measures
| Measure |
Phase 1
n=298 Participants
Phase 1 studied the MiniMed™ 780G insulin pump with Guardian 4 Sensor. Only the results for the Intention-to-Treat (ITT) population are included.
|
|---|---|
|
Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL) Phase 2 Transition + Naive
|
85.4 Percentage of TIR
Interval 84.3 to 86.4
|
SECONDARY outcome
Timeframe: Last 6 weeks of 3 month study periodPopulation: Study period: 95 subjects in Phase 1. 91 subjects have available measurements.
The mean percent of time in range (TIR 70-180 mg/dL). Superiority test.
Outcome measures
| Measure |
Phase 1
n=91 Participants
Phase 1 studied the MiniMed™ 780G insulin pump with Guardian 4 Sensor. Only the results for the Intention-to-Treat (ITT) population are included.
|
|---|---|
|
Secondary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL) Phase 1
|
80.9 Percentage of TIR
Interval 78.4 to 83.1
|
SECONDARY outcome
Timeframe: Last 6 weeks of 3 month study periodPopulation: Study period: 302 subjects in Phase 2 Transition + Naive. 298 subjects have available measurements.
The mean percent of time in range (TIR 70-180 mg/dL). Superiority test.
Outcome measures
| Measure |
Phase 1
n=298 Participants
Phase 1 studied the MiniMed™ 780G insulin pump with Guardian 4 Sensor. Only the results for the Intention-to-Treat (ITT) population are included.
|
|---|---|
|
Secondary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL) Phase 2 Transition + Naive
|
85.4 Percentage of TIR
Interval 84.3 to 86.4
|
Adverse Events
Phase 1
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
Phase 2
Serious events: 10 serious events
Other events: 114 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1
n=95 participants at risk
Phase 1 studied the MiniMed™ 780G insulin pump with Guardian 4 Sensor. Only the results for the Intention-to-Treat (ITT) population are included.
|
Phase 2
n=302 participants at risk
Phase 2 studied the MiniMed™ 780G BLE 2.0 insulin pump with the disposable sensor DS5. Only the results for the Intention-to-Treat (ITT) population are included.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Cardiac disorders
Bradycardia
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.66%
2/302 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.66%
2/302 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Unevaluable event
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Device related infection
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Septic shock
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Vascular disorders
Hypertensive urgency
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
Other adverse events
| Measure |
Phase 1
n=95 participants at risk
Phase 1 studied the MiniMed™ 780G insulin pump with Guardian 4 Sensor. Only the results for the Intention-to-Treat (ITT) population are included.
|
Phase 2
n=302 participants at risk
Phase 2 studied the MiniMed™ 780G BLE 2.0 insulin pump with the disposable sensor DS5. Only the results for the Intention-to-Treat (ITT) population are included.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Cardiac disorders
Palpitations
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Gastrointestinal disorders
Mouth cyst
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.66%
2/302 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Chest discomfort
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Chest pain
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Fatigue
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Infusion site bruising
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Endocrine disorders
Hypothyroidism
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Eye disorders
Cataract
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.66%
2/302 • Number of events 3 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Eye disorders
Diabetic retinal oedema
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.66%
2/302 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Eye disorders
Dry eye
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Eye disorders
Glaucoma
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Eye disorders
Trichiasis
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.66%
2/302 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
1.7%
5/302 • Number of events 5 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Folliculitis
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Fungal infection
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.66%
2/302 • Number of events 3 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Infusion site dermatitis
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Infusion site reaction
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Infusion site swelling
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Injection site reaction
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Influenza
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Malaise
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.66%
2/302 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Localised infection
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Medical device site bruise
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Medical device site pustule
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
2.6%
8/302 • Number of events 8 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Medical device site discolouration
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Medical device site erythema
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Medical device site haemorrhage
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
2.6%
8/302 • Number of events 9 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Medical device site irritation
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
1.3%
4/302 • Number of events 6 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Otitis media
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Medical device site mass
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Pharyngitis
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Medical device site pain
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.99%
3/302 • Number of events 3 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Medical device site pruritus
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Medical device site rash
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Medical device site reaction
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.66%
2/302 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Medical device site swelling
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Oedema peripheral
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Sinusitis
|
2.1%
2/95 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.99%
3/302 • Number of events 3 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Pain
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Pyrexia
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
General disorders and administration site conditions
Ulcer
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
COVID-19
|
6.3%
6/95 • Number of events 6 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
3.3%
10/302 • Number of events 10 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Conjunctivitis
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Conjunctivitis bacterial
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.66%
2/302 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Cystitis
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Ear infection
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.99%
3/302 • Number of events 3 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Injury, poisoning and procedural complications
Fall
|
2.1%
2/95 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Skin infection
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.2%
4/95 • Number of events 4 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
1.7%
5/302 • Number of events 5 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
2/95 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
2.0%
6/302 • Number of events 6 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.66%
2/302 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.66%
2/302 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.66%
2/302 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.99%
3/302 • Number of events 3 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.66%
2/302 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
1.7%
5/302 • Number of events 5 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.1%
2/95 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.66%
2/302 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.99%
3/302 • Number of events 3 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Nervous system disorders
Cluster headache
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Nervous system disorders
Headache
|
1.1%
1/95 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.99%
3/302 • Number of events 3 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Nervous system disorders
Petit mal epilepsy
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Psychiatric disorders
Anxiety
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.66%
2/302 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.1%
2/95 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
2.1%
2/95 • Number of events 2 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.00%
0/302 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Vascular disorders
Hot flush
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/95 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/95 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
0.33%
1/302 • Number of events 1 • Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
|
Additional Information
Thomas Troub, Sr Clinical Research Manager
Medtronic Diabetes
Phone: 1-800-646-4633
Email: [email protected]
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 ot he communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER