Trial Outcomes & Findings for Observational Study to Evaluate the Safety of Levemir® in Diabetes (NCT NCT00659295)
NCT ID: NCT00659295
Last Updated: 2017-03-10
Results Overview
The incidence of serious adverse reactions (SARs), including major hypoglycaemic events, during 3 months of insulin detemir therapy for all countries participating in the study, and during 6 and 12 months of insulin detemir therapy for some of the participating countries. The three sub-groups were mutually exclusive. Physicians did not report all major hypoglycaemic events as SARs. The values in the SAE table are SARs including only those major hypoglycaemic events that were reported as SARs by physicians.
Recruitment status
COMPLETED
Target enrollment
51170 participants
Primary outcome timeframe
Months 0-12
Results posted on
2017-03-10
Participant Flow
Study conducted globally in 26 countries. Some countries participated for only 3 months, while others extended their participation to 6 and 12 months, respectively.
Subjects with type 1 or type 2 diabetes including newly diagnosed subjects who had never received insulin or an insulin analogue at the prescribing physician's discretion.
Participant milestones
| Measure |
Type 1 Diabetes
Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
|
Type 2 Diabetes
Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
13529
|
37641
|
|
Overall Study
COMPLETED
|
10821
|
32038
|
|
Overall Study
NOT COMPLETED
|
2708
|
5603
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Observational Study to Evaluate the Safety of Levemir® in Diabetes
Baseline characteristics by cohort
| Measure |
Type 1 Diabetes
n=13529 Participants
Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
|
Type 2 Diabetes
n=37641 Participants
Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
|
Total
n=51170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Austria, n=331, 430
|
41.9 years
STANDARD_DEVIATION 13.8 • n=93 Participants
|
60.8 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
52.6 years
STANDARD_DEVIATION 12.5 • n=27 Participants
|
|
Age, Continuous
Brazil, n=962, 1136
|
29.6 years
STANDARD_DEVIATION 15.5 • n=93 Participants
|
60.3 years
STANDARD_DEVIATION 12.9 • n=4 Participants
|
46.2 years
STANDARD_DEVIATION 14.1 • n=27 Participants
|
|
Age, Continuous
Denmark, n=312, 77
|
45.6 years
STANDARD_DEVIATION 13.3 • n=93 Participants
|
61.4 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
48.7 years
STANDARD_DEVIATION 12.8 • n=27 Participants
|
|
Age, Continuous
Germany, n=2640, 7526
|
45.0 years
STANDARD_DEVIATION 15.7 • n=93 Participants
|
62.3 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
57.8 years
STANDARD_DEVIATION 11.8 • n=27 Participants
|
|
Age, Continuous
Israel, n=295, 722
|
36.5 years
STANDARD_DEVIATION 20.0 • n=93 Participants
|
60.2 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
53.3 years
STANDARD_DEVIATION 13.7 • n=27 Participants
|
|
Age, Continuous
Lebanon, n=63, 192
|
27.6 years
STANDARD_DEVIATION 10.3 • n=93 Participants
|
58.2 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
50.6 years
STANDARD_DEVIATION 11.3 • n=27 Participants
|
|
Age, Continuous
Russia, n=1121, 2515
|
28.5 years
STANDARD_DEVIATION 15.8 • n=93 Participants
|
58.7 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
49.4 years
STANDARD_DEVIATION 11.6 • n=27 Participants
|
|
Age, Continuous
Slovenia, n=91, 209
|
42.3 years
STANDARD_DEVIATION 14.5 • n=93 Participants
|
59.1 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
54.0 years
STANDARD_DEVIATION 11.4 • n=27 Participants
|
|
Age, Continuous
Turkey, n=622, 2132
|
28.9 years
STANDARD_DEVIATION 15.2 • n=93 Participants
|
55.9 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
49.8 years
STANDARD_DEVIATION 11.6 • n=27 Participants
|
|
Age, Continuous
Belgium/Luxembourg, n=330, 38
|
45.2 years
STANDARD_DEVIATION 15.4 • n=93 Participants
|
62.4 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
47.0 years
STANDARD_DEVIATION 14.8 • n=27 Participants
|
|
Age, Continuous
Czech Republic, n=861, 820
|
45.3 years
STANDARD_DEVIATION 16.8 • n=93 Participants
|
59.4 years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
52.2 years
STANDARD_DEVIATION 13.8 • n=27 Participants
|
|
Age, Continuous
Greece, n=125, 923
|
31.6 years
STANDARD_DEVIATION 16.3 • n=93 Participants
|
64.9 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
60.9 years
STANDARD_DEVIATION 11.8 • n=27 Participants
|
|
Age, Continuous
India, n=142, 3162
|
31.4 years
STANDARD_DEVIATION 17.0 • n=93 Participants
|
52.6 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
51.7 years
STANDARD_DEVIATION 10.4 • n=27 Participants
|
|
Age, Continuous
Italy, n=177, 1297
|
44.6 years
STANDARD_DEVIATION 16.0 • n=93 Participants
|
64.9 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
62.5 years
STANDARD_DEVIATION 11.5 • n=27 Participants
|
|
Age, Continuous
Netherlands, n=92, 324
|
39.9 years
STANDARD_DEVIATION 16.6 • n=93 Participants
|
59.7 years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
55.3 years
STANDARD_DEVIATION 13.8 • n=27 Participants
|
|
Age, Continuous
Saudi Arabia, n=104, 503
|
25.0 years
STANDARD_DEVIATION 13.1 • n=93 Participants
|
50.0 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
45.7 years
STANDARD_DEVIATION 10.9 • n=27 Participants
|
|
Age, Continuous
South Africa, n=207, 247
|
33.6 years
STANDARD_DEVIATION 16.0 • n=93 Participants
|
53.3 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
44.3 years
STANDARD_DEVIATION 13.8 • n=27 Participants
|
|
Age, Continuous
South Korea, n=224, 8854
|
36.0 years
STANDARD_DEVIATION 16.0 • n=93 Participants
|
56.9 years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
56.4 years
STANDARD_DEVIATION 12.5 • n=27 Participants
|
|
Age, Continuous
Sweden, n=553, 95
|
42.0 years
STANDARD_DEVIATION 17.5 • n=93 Participants
|
61.3 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
44.8 years
STANDARD_DEVIATION 16.6 • n=27 Participants
|
|
Age, Continuous
Tunisia, n=21, 316
|
24.5 years
STANDARD_DEVIATION 15.9 • n=93 Participants
|
57.6 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
55.5 years
STANDARD_DEVIATION 11.4 • n=27 Participants
|
|
Age, Continuous
United Kingdom/Ireland, n=2292, 1832
|
35.5 years
STANDARD_DEVIATION 17.6 • n=93 Participants
|
59.2 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
46.0 years
STANDARD_DEVIATION 15.0 • n=27 Participants
|
|
Age, Continuous
Finland, n=809, 249
|
41.9 years
STANDARD_DEVIATION 14.3 • n=93 Participants
|
58.8 years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
45.9 years
STANDARD_DEVIATION 13.5 • n=27 Participants
|
|
Age, Continuous
France, n=641, 1127
|
47.1 years
STANDARD_DEVIATION 16.1 • n=93 Participants
|
62.6 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
57.0 years
STANDARD_DEVIATION 13.4 • n=27 Participants
|
|
Age, Continuous
Japan, n=490, 2801
|
50.5 years
STANDARD_DEVIATION 16.1 • n=93 Participants
|
61.9 years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
60.2 years
STANDARD_DEVIATION 13.3 • n=27 Participants
|
|
Sex/Gender, Customized
Female
|
6865 participants
n=93 Participants
|
19175 participants
n=4 Participants
|
26040 participants
n=27 Participants
|
|
Sex/Gender, Customized
Male
|
6658 participants
n=93 Participants
|
18453 participants
n=4 Participants
|
25111 participants
n=27 Participants
|
|
Sex/Gender, Customized
Not specified
|
6 participants
n=93 Participants
|
13 participants
n=4 Participants
|
19 participants
n=27 Participants
|
|
Duration of diabetes (3 months' participation)
Austria, n=330, 428
|
18.5 years
STANDARD_DEVIATION 13.6 • n=93 Participants
|
12.5 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
15.1 years
STANDARD_DEVIATION 10.7 • n=27 Participants
|
|
Duration of diabetes (3 months' participation)
Brazil, n=959, 1141
|
12.6 years
STANDARD_DEVIATION 9.7 • n=93 Participants
|
13.7 years
STANDARD_DEVIATION 9.0 • n=4 Participants
|
13.2 years
STANDARD_DEVIATION 9.3 • n=27 Participants
|
|
Duration of diabetes (3 months' participation)
Denmark, n=312, 76
|
20.4 years
STANDARD_DEVIATION 12.6 • n=93 Participants
|
11.8 years
STANDARD_DEVIATION 6.6 • n=4 Participants
|
18.7 years
STANDARD_DEVIATION 11.4 • n=27 Participants
|
|
Duration of diabetes (3 months' participation)
Germany, n=2607, 7468
|
17.2 years
STANDARD_DEVIATION 12.5 • n=93 Participants
|
10.6 years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
12.3 years
STANDARD_DEVIATION 8.6 • n=27 Participants
|
|
Duration of diabetes (3 months' participation)
Israel, n=286, 721
|
14.3 years
STANDARD_DEVIATION 12.4 • n=93 Participants
|
15.7 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
15.3 years
STANDARD_DEVIATION 10.0 • n=27 Participants
|
|
Duration of diabetes (3 months' participation)
Lebanon, n=63, 192
|
11.4 years
STANDARD_DEVIATION 7.7 • n=93 Participants
|
12.2 years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
12.0 years
STANDARD_DEVIATION 7.2 • n=27 Participants
|
|
Duration of diabetes (3 months' participation)
Russia, n=1112, 2509
|
8.5 years
STANDARD_DEVIATION 8.2 • n=93 Participants
|
9.5 years
STANDARD_DEVIATION 5.8 • n=4 Participants
|
9.2 years
STANDARD_DEVIATION 6.5 • n=27 Participants
|
|
Duration of diabetes (3 months' participation)
Slovenia, n=90, 208
|
18.1 years
STANDARD_DEVIATION 13.0 • n=93 Participants
|
13.7 years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
15.0 years
STANDARD_DEVIATION 9.5 • n=27 Participants
|
|
Duration of diabetes (3 months' participation)
Turkey, n=612, 2127
|
8.2 years
STANDARD_DEVIATION 6.7 • n=93 Participants
|
10.6 years
STANDARD_DEVIATION 6.6 • n=4 Participants
|
10.1 years
STANDARD_DEVIATION 6.6 • n=27 Participants
|
|
Duration of diabetes (6 months' participation)
Belgium/Luxembourg, n=329, 38
|
17.7 years
STANDARD_DEVIATION 12.3 • n=93 Participants
|
14.0 years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
17.3 years
STANDARD_DEVIATION 12.0 • n=27 Participants
|
|
Duration of diabetes (6 months' participation)
Czech Republic, n=856, 807
|
14.5 years
STANDARD_DEVIATION 11.1 • n=93 Participants
|
12.8 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
13.7 years
STANDARD_DEVIATION 9.5 • n=27 Participants
|
|
Duration of diabetes (6 months' participation)
Greece, n=129, 956
|
11.9 years
STANDARD_DEVIATION 9.9 • n=93 Participants
|
13.4 years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
13.2 years
STANDARD_DEVIATION 7.9 • n=27 Participants
|
|
Duration of diabetes (6 months' participation)
India, n=139, 3178
|
6.6 years
STANDARD_DEVIATION 6.2 • n=93 Participants
|
8.5 years
STANDARD_DEVIATION 5.5 • n=4 Participants
|
8.4 years
STANDARD_DEVIATION 5.5 • n=27 Participants
|
|
Duration of diabetes (6 months' participation)
Italy, n=175, 1292
|
14.6 years
STANDARD_DEVIATION 11.6 • n=93 Participants
|
14.7 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
14.7 years
STANDARD_DEVIATION 9.0 • n=27 Participants
|
|
Duration of diabetes (6 months' participation)
Netherlands, n=88, 318
|
16.0 years
STANDARD_DEVIATION 14.5 • n=93 Participants
|
9.6 years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
11.0 years
STANDARD_DEVIATION 8.5 • n=27 Participants
|
|
Duration of diabetes (6 months' participation)
Saudi Arabia, n=96, 494
|
7.2 years
STANDARD_DEVIATION 6.3 • n=93 Participants
|
9.1 years
STANDARD_DEVIATION 5.6 • n=4 Participants
|
8.8 years
STANDARD_DEVIATION 5.7 • n=27 Participants
|
|
Duration of diabetes (6 months' participation)
South Africa, n=196, 243
|
11.3 years
STANDARD_DEVIATION 9.4 • n=93 Participants
|
9.9 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
10.5 years
STANDARD_DEVIATION 8.3 • n=27 Participants
|
|
Duration of diabetes (6 months' participation)
South Korea, n=214, 8701
|
9.4 years
STANDARD_DEVIATION 7.7 • n=93 Participants
|
10.1 years
STANDARD_DEVIATION 6.8 • n=4 Participants
|
10.1 years
STANDARD_DEVIATION 6.8 • n=27 Participants
|
|
Duration of diabetes (6 months' participation)
Sweden, n=547, 96
|
19.6 years
STANDARD_DEVIATION 14.2 • n=93 Participants
|
13.6 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
18.7 years
STANDARD_DEVIATION 13.2 • n=27 Participants
|
|
Duration of diabetes (6 months' participation)
Tunisia, n=21, 316
|
8.2 years
STANDARD_DEVIATION 7.7 • n=93 Participants
|
11.5 years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
11.3 years
STANDARD_DEVIATION 6.5 • n=27 Participants
|
|
Duration of diabetes (6 months' participation)
United Kingdom/Ireland, n=2260, 1827
|
15.2 years
STANDARD_DEVIATION 12.3 • n=93 Participants
|
11.3 years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
13.5 years
STANDARD_DEVIATION 10.2 • n=27 Participants
|
|
Duration of diabetes (12 months' participation)
Finland, n=796, 245
|
19.8 years
STANDARD_DEVIATION 12.3 • n=93 Participants
|
13.3 years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
18.3 years
STANDARD_DEVIATION 11.2 • n=27 Participants
|
|
Duration of diabetes (12 months' participation)
France, n=628, 1117
|
17 years
STANDARD_DEVIATION 12 • n=93 Participants
|
14.6 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
15.5 years
STANDARD_DEVIATION 10 • n=27 Participants
|
|
Duration of diabetes (12 months' participation)
Japan, n=420, 2240
|
12.1 years
STANDARD_DEVIATION 10 • n=93 Participants
|
14.2 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
13.9 years
STANDARD_DEVIATION 9.1 • n=27 Participants
|
PRIMARY outcome
Timeframe: Months 0-12Population: FAS (Full Analysis Set) consists of all patients with a baseline visit who were prescribed insulin detemir at least once
The incidence of serious adverse reactions (SARs), including major hypoglycaemic events, during 3 months of insulin detemir therapy for all countries participating in the study, and during 6 and 12 months of insulin detemir therapy for some of the participating countries. The three sub-groups were mutually exclusive. Physicians did not report all major hypoglycaemic events as SARs. The values in the SAE table are SARs including only those major hypoglycaemic events that were reported as SARs by physicians.
Outcome measures
| Measure |
Type 1 Diabetes
n=13529 Participants
Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
|
Type 2 Diabetes
n=37641 Participants
Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
|
|---|---|---|
|
Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events
3 months sub-group
|
186 participants
|
93 participants
|
|
Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events
6 months sub-group
|
208 participants
|
112 participants
|
|
Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events
12 months sub-group
|
109 participants
|
48 participants
|
Adverse Events
Type 1 Diabetes
Serious events: 130 serious events
Other events: 0 other events
Deaths: 0 deaths
Type 2 Diabetes
Serious events: 80 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Type 1 Diabetes
n=13529 participants at risk
Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
|
Type 2 Diabetes
n=37641 participants at risk
Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
|
|---|---|---|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
General disorders
Asthenia
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
General disorders
Chest pain
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
General disorders
Condition aggravated
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
General disorders
Death
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.01%
2/37641 • Number of events 2 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
General disorders
Hypothermia
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
General disorders
Injection site oedema
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
General disorders
Injection site rash
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.01%
2/37641 • Number of events 2 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
General disorders
Injection site erythema
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
General disorders
Injection site pruritus
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
General disorders
Pain
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
General disorders
Injection site pain
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.01%
2/37641 • Number of events 2 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
General disorders
Injection site reaction
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.01%
2/37641 • Number of events 2 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
General disorders
Injection site stinging
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
General disorders
Injection site warmth
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
General disorders
Generalised oedema
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
General disorders
Malaise
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
General disorders
Pyrexia
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
General disorders
Sudden death
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Hepatobiliary disorders
Hepatitis
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Infections and infestations
Tinea capitis
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Infections and infestations
Gastroenteritis
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Infections and infestations
Pneumonia
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Infections and infestations
Cellulitis
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Injury, poisoning and procedural complications
Blister
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Injury, poisoning and procedural complications
Contusion
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Injury, poisoning and procedural complications
Fall
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Injury, poisoning and procedural complications
Limp injury
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Injury, poisoning and procedural complications
Medication error
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Investigations
Blood glucose increase
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Investigations
Blood glucose fluctuation
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Investigations
Blood glucose decrease
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.01%
3/37641 • Number of events 3 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.03%
4/13529 • Number of events 7 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.04%
5/13529 • Number of events 5 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.01%
5/37641 • Number of events 5 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.49%
66/13529 • Number of events 73 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.09%
33/37641 • Number of events 34 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Metabolism and nutrition disorders
Hypoglycaemia unawareness
|
0.06%
8/13529 • Number of events 8 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Metabolism and nutrition disorders
Hypoglycaemic seizure
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Metabolism and nutrition disorders
Hypoglycaemic unconsciousness
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Nervous system disorders
Coma acidotic
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Nervous system disorders
Convulsion
|
0.01%
2/13529 • Number of events 2 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Nervous system disorders
Depressed level of consciousness
|
0.01%
2/13529 • Number of events 2 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.01%
2/37641 • Number of events 2 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.16%
21/13529 • Number of events 21 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.02%
7/37641 • Number of events 11 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Nervous system disorders
Hypoglycaemic encephalopathy
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Nervous system disorders
Loss of consciousness
|
0.04%
6/13529 • Number of events 6 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Psychiatric disorders
Anxiety
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Skin and subcutaneous tissue disorders
Pityriasis rubra pilaris
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Surgical and medical procedures
Transmyocardial revascularisation
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Vascular disorders
Hyperaemia
|
0.01%
1/13529 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
0/37641 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
|
Vascular disorders
Hypertension
|
0.00%
0/13529 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
0.00%
1/37641 • Number of events 1 • Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk acknowledges the physician's right to publish the entire results of the trial. Any such scientific paper, presentation, communication, or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
- Publication restrictions are in place
Restriction type: OTHER