Trial Outcomes & Findings for Evaluation of the MiniMed 780 System in Paediatric Subjects (NCT NCT05574062)
NCT ID: NCT05574062
Last Updated: 2025-06-19
Results Overview
The primary endpoint is the between-treatment difference in the percentage of time that the sensor glucose measurement is in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L), non-inferiority test.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
101 participants
Primary outcome timeframe
12 weeks for each cross-over period
Results posted on
2025-06-19
Participant Flow
101 subjects signed the informed consent and were assessed for enrollment. Out of them, 3 screening failures due to the following inclusion criteria not met: "Investigator has confidence that the parent(s)/ legal guardian(s) can successfully operate all study devices and is capable of adhering to the protocol" discontinued the study before starting the run-in phase.
Run-in period
Participant milestones
| Measure |
All Subjects
The entire study population (this group is intended for clarification and reporting into the CT.gov PRS
|
Sequence A
Subjects used the MiniMed 780G (with G4S sensor) system in Auto Mode for 12 weeks followed by 2 weeks of washout period where the system was used in Manual Mode with SBL activated. After the washout period the subjects used the MiniMed 780G system in Manual Mode with SBL activated for the remaining 12 weeks.
|
Sequence B
Subjects used the MiniMed 780G (with G4S sensor) system in Manual Mode with SBL activated (Sequence B) for 12 weeks followed by 2 weeks of washout period where the system was used in Manual Mode with SBL activated. After the washout period the subjects used the MiniMed 780G system in Auto Mode for the remaining 12 weeks.
|
Arm A2
Arm A2: Subjects will start using the MiniMed™ 780G BLE 2.0 system with the DS5 sensor for 12 weeks
|
Arm B2
Arm B2: Subjects will continue to use MiniMed™ 780G system in Auto Mode for 12 weeks
|
|---|---|---|---|---|---|
|
Pre Run-In
STARTED
|
101
|
0
|
0
|
0
|
0
|
|
Pre Run-In
COMPLETED
|
98
|
0
|
0
|
0
|
0
|
|
Pre Run-In
NOT COMPLETED
|
3
|
0
|
0
|
0
|
0
|
|
Run-in
STARTED
|
98
|
0
|
0
|
0
|
0
|
|
Run-in
COMPLETED
|
98
|
0
|
0
|
0
|
0
|
|
Run-in
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Study Phase Period 1
STARTED
|
0
|
50
|
48
|
0
|
0
|
|
Study Phase Period 1
COMPLETED
|
0
|
49
|
48
|
0
|
0
|
|
Study Phase Period 1
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
|
Wash-out Period
STARTED
|
0
|
49
|
48
|
0
|
0
|
|
Wash-out Period
COMPLETED
|
0
|
49
|
48
|
0
|
0
|
|
Wash-out Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Study Phase Period 2
STARTED
|
0
|
49
|
48
|
0
|
0
|
|
Study Phase Period 2
COMPLETED
|
0
|
48
|
48
|
0
|
0
|
|
Study Phase Period 2
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
|
Continuation Phase Period 1
STARTED
|
95
|
0
|
0
|
0
|
0
|
|
Continuation Phase Period 1
COMPLETED
|
91
|
0
|
0
|
0
|
0
|
|
Continuation Phase Period 1
NOT COMPLETED
|
4
|
0
|
0
|
0
|
0
|
|
Continuation Phase Period 2
STARTED
|
0
|
0
|
0
|
45
|
46
|
|
Continuation Phase Period 2
COMPLETED
|
0
|
0
|
0
|
44
|
46
|
|
Continuation Phase Period 2
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
All Subjects
The entire study population (this group is intended for clarification and reporting into the CT.gov PRS
|
Sequence A
Subjects used the MiniMed 780G (with G4S sensor) system in Auto Mode for 12 weeks followed by 2 weeks of washout period where the system was used in Manual Mode with SBL activated. After the washout period the subjects used the MiniMed 780G system in Manual Mode with SBL activated for the remaining 12 weeks.
|
Sequence B
Subjects used the MiniMed 780G (with G4S sensor) system in Manual Mode with SBL activated (Sequence B) for 12 weeks followed by 2 weeks of washout period where the system was used in Manual Mode with SBL activated. After the washout period the subjects used the MiniMed 780G system in Auto Mode for the remaining 12 weeks.
|
Arm A2
Arm A2: Subjects will start using the MiniMed™ 780G BLE 2.0 system with the DS5 sensor for 12 weeks
|
Arm B2
Arm B2: Subjects will continue to use MiniMed™ 780G system in Auto Mode for 12 weeks
|
|---|---|---|---|---|---|
|
Pre Run-In
Screening failure
|
3
|
0
|
0
|
0
|
0
|
|
Study Phase Period 1
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
|
Study Phase Period 2
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
|
Continuation Phase Period 1
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
|
Continuation Phase Period 1
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
|
Continuation Phase Period 1
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
|
Continuation Phase Period 1
Death
|
1
|
0
|
0
|
0
|
0
|
|
Continuation Phase Period 2
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study Phase - Sequence A
n=50 Participants
Subjects used the MiniMed 780G (with G4S sensor) system in Auto Mode for 12 weeks (Treatment), followed by 2 weeks of washout period where the system was used in Manual Mode with SBL activated (Control).
After the washout period the subjects used the MiniMed 780G (with G4S sensor) system in Manual Mode with SBL activated (Control).
MiniMed 780G Auto Mode with G4S sensor: MiniMed™ 780G system in Auto Mode with G4S sensor.
MiniMed 780G Manual Mode with G4S sensor: MiniMed™ 780G system in Manual Mode.
|
Study Phase - Sequence B
n=48 Participants
Subjects used the MiniMed 780G (with G4S sensor) system in Manual Mode with SBL activated for 12 weeks (Control), followed by 2 weeks of washout period where the system was used in Manual Mode with SBL activated (Control).
After the washout period the subjects used the MiniMed 780G (with G4S sensor) system in Auto Mode (Treatment).
MiniMed 780G Auto Mode with G4S sensor: MiniMed™ 780G system in Auto Mode with G4S sensor.
MiniMed 780G Manual Mode with G4S sensor: MiniMed™ 780G system in Manual Mode.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.61 years
STANDARD_DEVIATION 1.076 • n=50 Participants
|
4.84 years
STANDARD_DEVIATION 1.234 • n=48 Participants
|
4.72 years
STANDARD_DEVIATION 1.156 • n=98 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=50 Participants
|
25 Participants
n=48 Participants
|
48 Participants
n=98 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=50 Participants
|
23 Participants
n=48 Participants
|
50 Participants
n=98 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Finland
|
12 participants
n=50 Participants
|
15 participants
n=48 Participants
|
27 participants
n=98 Participants
|
|
Region of Enrollment
United Kingdom
|
15 participants
n=50 Participants
|
11 participants
n=48 Participants
|
26 participants
n=98 Participants
|
|
Region of Enrollment
Italy
|
13 participants
n=50 Participants
|
12 participants
n=48 Participants
|
25 participants
n=98 Participants
|
|
Region of Enrollment
Slovenia
|
10 participants
n=50 Participants
|
10 participants
n=48 Participants
|
20 participants
n=98 Participants
|
PRIMARY outcome
Timeframe: 12 weeks for each cross-over periodThe primary endpoint is the between-treatment difference in the percentage of time that the sensor glucose measurement is in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L), non-inferiority test.
Outcome measures
| Measure |
MiniMed 780G (With G4S Sensor) System in Auto Mode
n=97 Participants
Data from period 1 for subjects randomized in Sequence A Data from period 2 for subjects randomized in Sequence B
|
MiniMed 780G (With G4S Sensor) System in Manual Mode + SBL
n=97 Participants
Data from period 2 for subjects randomized in Sequence A Data from period 1 for subjects randomized in Sequence B
|
|---|---|---|
|
Study Phase Primary Endpoint: Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Non-inferiority Test
|
68.34 percentage of time
Standard Deviation 6.922
|
58.34 percentage of time
Standard Deviation 12.455
|
PRIMARY outcome
Timeframe: The outcome was measured at the end of the 12-week continuation phase period 2Population: The number of subjects with endpoint measurements available at the end of the continuation phase period 2 were 38 out of 45 and 42 out of 46 for arm A2 and arm B2, respectively
The primary endpoint for continuation phase is the between-treatment difference in the mean HbA1c (%) at the end of 12-week continuation phase period 2. The endpoint will be assessed for non-inferiority with an absolute margin of 0.4% HbA1c.
Outcome measures
| Measure |
MiniMed 780G (With G4S Sensor) System in Auto Mode
n=38 Participants
Data from period 1 for subjects randomized in Sequence A Data from period 2 for subjects randomized in Sequence B
|
MiniMed 780G (With G4S Sensor) System in Manual Mode + SBL
n=42 Participants
Data from period 2 for subjects randomized in Sequence A Data from period 1 for subjects randomized in Sequence B
|
|---|---|---|
|
Continuation Phase Primary Endpoint: Mean HbA1c (%) - Non-inferiority Test
|
7.30 % of hba1c
Standard Deviation 0.529
|
7.24 % of hba1c
Standard Deviation 0.643
|
SECONDARY outcome
Timeframe: The outcome was measured at the end of each 12 week cross-over periodBetween-treatment difference in mean HbA1c at the end of each 12-week cross-over period, non-inferiority test.
Outcome measures
| Measure |
MiniMed 780G (With G4S Sensor) System in Auto Mode
n=97 Participants
Data from period 1 for subjects randomized in Sequence A Data from period 2 for subjects randomized in Sequence B
|
MiniMed 780G (With G4S Sensor) System in Manual Mode + SBL
n=96 Participants
Data from period 2 for subjects randomized in Sequence A Data from period 1 for subjects randomized in Sequence B
|
|---|---|---|
|
Study Phase Secondary Endpoint 1- Mean HbA1c (%) - Non-inferiority Test
|
7.00 % of hba1c
Standard Deviation 0.533
|
7.61 % of hba1c
Standard Deviation 0.906
|
SECONDARY outcome
Timeframe: 12 weeks for each cross-over periodBetween-treatment difference in % Time spent in target range (70 to 180 mg/dL \[3.9-10.0 mmol/L\]), during each 12 week cross-over period, superiority test.
Outcome measures
| Measure |
MiniMed 780G (With G4S Sensor) System in Auto Mode
n=97 Participants
Data from period 1 for subjects randomized in Sequence A Data from period 2 for subjects randomized in Sequence B
|
MiniMed 780G (With G4S Sensor) System in Manual Mode + SBL
n=97 Participants
Data from period 2 for subjects randomized in Sequence A Data from period 1 for subjects randomized in Sequence B
|
|---|---|---|
|
Study Phase Secondary Endpoint 2 - Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Superiority Test
|
68.34 percentage of time
Standard Deviation 6.922
|
58.34 percentage of time
Standard Deviation 12.455
|
SECONDARY outcome
Timeframe: The outcome was measured at the end of each 12 week cross-over periodBetween-treatment difference in mean HbA1c at the end of each 12-week cross-over period, superiority test.
Outcome measures
| Measure |
MiniMed 780G (With G4S Sensor) System in Auto Mode
n=97 Participants
Data from period 1 for subjects randomized in Sequence A Data from period 2 for subjects randomized in Sequence B
|
MiniMed 780G (With G4S Sensor) System in Manual Mode + SBL
n=96 Participants
Data from period 2 for subjects randomized in Sequence A Data from period 1 for subjects randomized in Sequence B
|
|---|---|---|
|
Study Phase Secondary Endpoint 3 - Mean HbA1c (%) - Superiority Test.
|
7.00 % of hba1c
Standard Deviation 0.533
|
7.61 % of hba1c
Standard Deviation 0.906
|
SECONDARY outcome
Timeframe: The outcome was measured at the end of the 12-week continuation phase period 2Between-treatment difference in Mean HbA1c at the end of the 12-week continuation phase period 2, superiority test.
Outcome measures
| Measure |
MiniMed 780G (With G4S Sensor) System in Auto Mode
n=38 Participants
Data from period 1 for subjects randomized in Sequence A Data from period 2 for subjects randomized in Sequence B
|
MiniMed 780G (With G4S Sensor) System in Manual Mode + SBL
n=42 Participants
Data from period 2 for subjects randomized in Sequence A Data from period 1 for subjects randomized in Sequence B
|
|---|---|---|
|
Continuation Phase Secondary Endpoint 1- Mean HbA1c (%) - Superiority Test
|
7.30 % of hba1c
Standard Deviation 0.529
|
7.24 % of hba1c
Standard Deviation 0.643
|
SECONDARY outcome
Timeframe: 12 weeks of continuation phase period 2Between-treatment difference in % Time spent in target range (70 to 180 mg/dL \[3.9-10.0 mmol/L\]) during the end 12-week continuation phase period 2, non-inferiority test
Outcome measures
| Measure |
MiniMed 780G (With G4S Sensor) System in Auto Mode
n=44 Participants
Data from period 1 for subjects randomized in Sequence A Data from period 2 for subjects randomized in Sequence B
|
MiniMed 780G (With G4S Sensor) System in Manual Mode + SBL
n=46 Participants
Data from period 2 for subjects randomized in Sequence A Data from period 1 for subjects randomized in Sequence B
|
|---|---|---|
|
Continuation Phase Secondary Endpoint 2- Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Non-inferiority Test
|
69.7 percentage of time
Standard Deviation 7.728
|
68.8 percentage of time
Standard Deviation 8.615
|
SECONDARY outcome
Timeframe: 12 weeks of continuation phase period 2Between-treatment difference in % Time spent in target range (70 to 180 mg/dL \[3.9-10.0 mmol/L\]) during the end 12-week continuation phase period 2, superiority test.
Outcome measures
| Measure |
MiniMed 780G (With G4S Sensor) System in Auto Mode
n=44 Participants
Data from period 1 for subjects randomized in Sequence A Data from period 2 for subjects randomized in Sequence B
|
MiniMed 780G (With G4S Sensor) System in Manual Mode + SBL
n=46 Participants
Data from period 2 for subjects randomized in Sequence A Data from period 1 for subjects randomized in Sequence B
|
|---|---|---|
|
Continuation Phase Secondary Endpoint 3- Percentage of Time in Range (TIR 70 to 180 mg/dL [3.9-10.0 mmol/L]) - Superiority Test
|
69.66 percentage of time
Standard Deviation 7.734
|
68.86 percentage of time
Standard Deviation 8.615
|
Adverse Events
Run-In Period
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
MiniMed 780G (With G4S Sensor) System in Auto Mode - Study Phase
Serious events: 5 serious events
Other events: 45 other events
Deaths: 0 deaths
Wash-out Period
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
MiniMed 780G (With G4S Sensor) System in Manual Mode + SBL - Study Phase
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Continuation Phase Period 1
Serious events: 4 serious events
Other events: 37 other events
Deaths: 1 deaths
MiniMed 780G (With DS5 Sensor) System in Auto Mode - Continuation Phase Period 2
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
MiniMed 780G (With G4S Sensor) System in Auto Mode - Continuation Phase Period 2
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Run-In Period
n=98 participants at risk
All Enrolled subjects had a 2 week run-in period before randomization using the MiniMed 780G (with G4S sensor) system in Manual Mode + SBL
|
MiniMed 780G (With G4S Sensor) System in Auto Mode - Study Phase
n=98 participants at risk
Data from period 1 for subjects randomized in Sequence A Data from period 2 for subjects randomized in Sequence B
|
Wash-out Period
n=97 participants at risk
2 week run-in period between cross-over period 1 and period 2 using the MiniMed 780G (with G4S sensor) system in Manual Mode + SBL
|
MiniMed 780G (With G4S Sensor) System in Manual Mode + SBL - Study Phase
n=97 participants at risk
Data from period 2 for subjects randomized in Sequence A Data from period 1 for subjects randomized in Sequence B
|
Continuation Phase Period 1
n=95 participants at risk
18 week period using the MiniMed 780G (with G4S sensor) system in Auto Mode before second randomization
|
MiniMed 780G (With DS5 Sensor) System in Auto Mode - Continuation Phase Period 2
n=45 participants at risk
Data from continuation phase period 2 for subjects randomized in Arm A2
|
MiniMed 780G (With G4S Sensor) System in Auto Mode - Continuation Phase Period 2
n=46 participants at risk
Data from continuation phase period 2 for subjects randomized in Arm A2
|
|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Left tibia fracture
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
1.0%
1/97 • Number of events 1 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/95 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/45 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/46 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
|
Metabolism and nutrition disorders
DKA
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
1.0%
1/98 • Number of events 1 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/95 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/45 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/46 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
|
Infections and infestations
ACUTE BRONCHITIS
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
1.0%
1/98 • Number of events 1 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/95 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/45 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/46 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
1.0%
1/98 • Number of events 1 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/95 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/45 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/46 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
|
Infections and infestations
Gastroenteritis
|
1.0%
1/98 • Number of events 1 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
1.0%
1/98 • Number of events 1 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/95 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
2.2%
1/45 • Number of events 1 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/46 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
|
Respiratory, thoracic and mediastinal disorders
Viral Induced Wheeze
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
1.0%
1/97 • Number of events 1 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/95 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/45 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/46 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
|
Infections and infestations
Scarlet Fever
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
1.0%
1/98 • Number of events 1 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
1.1%
1/95 • Number of events 1 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/45 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/46 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
|
Infections and infestations
Lower Respiratory Infection
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
1.0%
1/97 • Number of events 1 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/95 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/45 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/46 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
|
Infections and infestations
Varicella infection with secondary supra-infection
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/95 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/45 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
2.2%
1/46 • Number of events 1 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
|
Immune system disorders
ALLERGIC REACTION TO AMOXICILLIN SUSP
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
1.1%
1/95 • Number of events 1 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/45 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/46 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
|
Respiratory, thoracic and mediastinal disorders
Reactive airway disease
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/95 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/45 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
2.2%
1/46 • Number of events 1 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
1.1%
1/95 • Number of events 1 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/45 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/46 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
|
Infections and infestations
MENINGOENCEPHALI TIS
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
1.1%
1/95 • Number of events 1 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/45 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/46 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
Other adverse events
| Measure |
Run-In Period
n=98 participants at risk
All Enrolled subjects had a 2 week run-in period before randomization using the MiniMed 780G (with G4S sensor) system in Manual Mode + SBL
|
MiniMed 780G (With G4S Sensor) System in Auto Mode - Study Phase
n=98 participants at risk
Data from period 1 for subjects randomized in Sequence A Data from period 2 for subjects randomized in Sequence B
|
Wash-out Period
n=97 participants at risk
2 week run-in period between cross-over period 1 and period 2 using the MiniMed 780G (with G4S sensor) system in Manual Mode + SBL
|
MiniMed 780G (With G4S Sensor) System in Manual Mode + SBL - Study Phase
n=97 participants at risk
Data from period 2 for subjects randomized in Sequence A Data from period 1 for subjects randomized in Sequence B
|
Continuation Phase Period 1
n=95 participants at risk
18 week period using the MiniMed 780G (with G4S sensor) system in Auto Mode before second randomization
|
MiniMed 780G (With DS5 Sensor) System in Auto Mode - Continuation Phase Period 2
n=45 participants at risk
Data from continuation phase period 2 for subjects randomized in Arm A2
|
MiniMed 780G (With G4S Sensor) System in Auto Mode - Continuation Phase Period 2
n=46 participants at risk
Data from continuation phase period 2 for subjects randomized in Arm A2
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
2.0%
2/98 • Number of events 2 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
6.1%
6/98 • Number of events 7 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
2.1%
2/97 • Number of events 2 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
1.0%
1/97 • Number of events 1 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
7.4%
7/95 • Number of events 7 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
2.2%
1/45 • Number of events 1 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
4.3%
2/46 • Number of events 3 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
|
General disorders
General disorders and administration site conditions
|
10.2%
10/98 • Number of events 10 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
13.3%
13/98 • Number of events 18 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
3.1%
3/97 • Number of events 3 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
9.3%
9/97 • Number of events 12 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
8.4%
8/95 • Number of events 10 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
4.4%
2/45 • Number of events 5 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
8.7%
4/46 • Number of events 4 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
|
Infections and infestations
Infections and infestations
|
6.1%
6/98 • Number of events 6 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
27.6%
27/98 • Number of events 36 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
7.2%
7/97 • Number of events 7 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
32.0%
31/97 • Number of events 48 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
32.6%
31/95 • Number of events 53 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
15.6%
7/45 • Number of events 9 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
23.9%
11/46 • Number of events 18 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.00%
0/98 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
5.1%
5/98 • Number of events 5 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
0.00%
0/97 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
3.1%
3/97 • Number of events 3 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
3.2%
3/95 • Number of events 3 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
4.4%
2/45 • Number of events 3 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
8.7%
4/46 • Number of events 4 • AE data were collected from the signature of the informed consent to the end of the continuation phase for approximately 58 weeks (2 weeks of run-in, 12 weeks of period 1, 2 weeks of wash-out, 12 weeks of period 2, 18 weeks of continuation phase period 1 and 12 weeks of continuation phase period 2).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place