Trial Outcomes & Findings for A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (NCT NCT05275400)
NCT ID: NCT05275400
Last Updated: 2025-06-03
Results Overview
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputation approach.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
986 participants
Primary outcome timeframe
Baseline, Week 26
Results posted on
2025-06-03
Participant Flow
Participants underwent a 3 week screening and lead-in period, and a 78-week treatment period, followed by a 5-week safety follow-up period.
Participant milestones
| Measure |
500 U/mL - Insulin Efsitora
Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW).
|
100 U/mL - Insulin Degludec
Participants received 100 U/mL insulin degludec administered SC once daily (QD).
|
|---|---|---|
|
Treatment Period
STARTED
|
655
|
331
|
|
Treatment Period
Received At Least 1 Dose of Study Drug
|
655
|
331
|
|
Treatment Period
COMPLETED
|
593
|
303
|
|
Treatment Period
NOT COMPLETED
|
62
|
28
|
|
Follow-Up Period
STARTED
|
614
|
306
|
|
Follow-Up Period
COMPLETED
|
608
|
306
|
|
Follow-Up Period
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
500 U/mL - Insulin Efsitora
Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW).
|
100 U/mL - Insulin Degludec
Participants received 100 U/mL insulin degludec administered SC once daily (QD).
|
|---|---|---|
|
Treatment Period
Adverse Event
|
7
|
1
|
|
Treatment Period
Assigned Treatment by Mistake
|
6
|
3
|
|
Treatment Period
Death
|
5
|
2
|
|
Treatment Period
Protocol Violation
|
1
|
0
|
|
Treatment Period
Physician Decision
|
5
|
4
|
|
Treatment Period
Non-Compliance with Study Drug
|
5
|
1
|
|
Treatment Period
Withdrawal by Subject
|
30
|
12
|
|
Treatment Period
Lost to Follow-up
|
1
|
5
|
|
Treatment Period
Lack of Efficacy
|
1
|
0
|
|
Treatment Period
Sponsor Decision
|
1
|
0
|
|
Follow-Up Period
Death
|
2
|
0
|
|
Follow-Up Period
Protocol Violation
|
1
|
0
|
|
Follow-Up Period
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin
Baseline characteristics by cohort
| Measure |
500 U/mL - Insulin Efsitora
n=655 Participants
Participants received 500 U/mL insulin efsitora administered SC QW.
|
100 U/mL - Insulin Degludec
n=331 Participants
Participants received 100 U/mL insulin degludec administered SC QD.
|
Total
n=986 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.60 years
STANDARD_DEVIATION 10.17 • n=5 Participants
|
60.80 years
STANDARD_DEVIATION 9.97 • n=7 Participants
|
60.70 years
STANDARD_DEVIATION 10.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
279 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
431 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
376 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
555 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
179 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
476 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
719 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
180 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
438 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
656 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
103 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
24 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
94 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
59 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
60 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
64 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
52 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
180 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
271 Participants
n=5 Participants
|
|
HemoglobinA1c (HbA1c)
|
7.8 Percentage of HbA1c
STANDARD_DEVIATION 0.9 • n=5 Participants
|
7.8 Percentage of HbA1c
STANDARD_DEVIATION 0.9 • n=7 Participants
|
7.8 Percentage of HbA1c
STANDARD_DEVIATION 0.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: All participants who received at least one dose of study drug and had evaluable data for this outcome at baseline or week 26. Participants who were assigned treatment by mistake were excluded.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputation approach.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=649 Participants
Participants received 500 U/mL insulin efsitora administered SC QW.
|
100 U/mL - Insulin Degludec
n=328 Participants
Participants received 100 U/mL insulin degludec administered SC QD.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority]
|
-0.81 Percentage of HbA1c
Standard Error 0.0302
|
-0.72 Percentage of HbA1c
Standard Error 0.0424
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All participants who received at least one dose of study drug and had evaluable data for this outcome at baseline or week 26. Participants who were assigned treatment by mistake were excluded.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputation approach.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=649 Participants
Participants received 500 U/mL insulin efsitora administered SC QW.
|
100 U/mL - Insulin Degludec
n=328 Participants
Participants received 100 U/mL insulin degludec administered SC QD.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) [Superiority]
|
-0.81 Percentage of HbA1c
Standard Error 0.0302
|
-0.72 Percentage of HbA1c
Standard Error 0.0424
|
SECONDARY outcome
Timeframe: Baseline up to Week 78Population: All participants who received at least one dose of study drug.
The event rate of participant-reported clinically significant glucose \<54 mg/dL (3.0 mmol/L) or severe nocturnal hypoglycemia that occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment period up to week 78. Group mean is reported here. Group mean is determined by Negative Binomial Model using Number of episodes = Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=655 Participants
Participants received 500 U/mL insulin efsitora administered SC QW.
|
100 U/mL - Insulin Degludec
n=331 Participants
Participants received 100 U/mL insulin degludec administered SC QD.
|
|---|---|---|
|
Nocturnal Hypoglycemia Event Rate
|
0.11 Events per year
Standard Error 0.022
|
0.10 Events per year
Standard Error 0.019
|
SECONDARY outcome
Timeframe: Week 22 to Week 26Population: All randomized participants who took at least one dose of the study drug and had evaluable data for this outcome at baseline or Week 22-26 were included. Participants who were assigned treatment by mistake were excluded.
Percentage of time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 millimoles per liter (mmol/L)) inclusive measured by continued glucose monitoring (CGM) during CGM session prior to week 26. LS Mean was calculated using ANCOVA model with Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data during CGM session prior to Week 26 were imputed by return-to-baseline multiple imputation approach.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=641 Participants
Participants received 500 U/mL insulin efsitora administered SC QW.
|
100 U/mL - Insulin Degludec
n=325 Participants
Participants received 100 U/mL insulin degludec administered SC QD.
|
|---|---|---|
|
Percentage of Time in Glucose Range Between 70 and 180 mg/dL (3.9 and 10.0 mmol/L)
|
61.37 Percentage of time
Standard Error 0.676
|
60.95 Percentage of time
Standard Error 0.954
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants who took at least one dose of the study drug and had evaluable data for this outcome at baseline or Week 26 were included. Participants who were assigned treatment by mistake were excluded.
Fasting glucose measured by Self-Monitoring of Blood Glucose (SMBG). LS Mean was determined using ANCOVA model with Baseline + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment (Type III sum of squares) as variables. Missing data at baseline are imputed with multiple imputation under assumption of missing at random. Missing data at Week 26 are imputed by return-to-baseline multiple imputation approach.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=648 Participants
Participants received 500 U/mL insulin efsitora administered SC QW.
|
100 U/mL - Insulin Degludec
n=327 Participants
Participants received 100 U/mL insulin degludec administered SC QD.
|
|---|---|---|
|
Change From Baseline in Fasting Glucose
|
-30.97 milligrams per deciliter (mg/dL)
Standard Error 0.943
|
-30.13 milligrams per deciliter (mg/dL)
Standard Error 1.323
|
SECONDARY outcome
Timeframe: Week 26Population: All participants who received at least one dose of study drug, had a baseline and at least one post-baseline value for this outcome. Participants who were assigned treatment by mistake were excluded.
The average weekly insulin dose at Week 26 was reported. LS Mean was determined by mixed model repeated measures (MMRM) model using BASELINE + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=647 Participants
Participants received 500 U/mL insulin efsitora administered SC QW.
|
100 U/mL - Insulin Degludec
n=327 Participants
Participants received 100 U/mL insulin degludec administered SC QD.
|
|---|---|---|
|
Weekly Insulin Dose at Week 26
|
333.20 Units per week of insulin
Standard Error 5.93
|
363.20 Units per week of insulin
Standard Error 8.33
|
SECONDARY outcome
Timeframe: Baseline up to Week 78Population: All participants who received at least one dose of study drug.
Patient reported events of hypoglycemia - Hypoglycemia with glucose \<54 mg/dL (Level 2) or Severe Hypoglycemia (Level 3) was reported. A severe hypoglycemic event is characterized by altered mental or physical status requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions for the treatment of hypoglycemia. Group mean was reported and determined by Negative binomial method using Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as variables.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=655 Participants
Participants received 500 U/mL insulin efsitora administered SC QW.
|
100 U/mL - Insulin Degludec
n=331 Participants
Participants received 100 U/mL insulin degludec administered SC QD.
|
|---|---|---|
|
Hypoglycemia Event Rate
|
0.84 Events per year
Standard Error 0.082
|
0.74 Events per year
Standard Error 0.098
|
SECONDARY outcome
Timeframe: Baseline, Week 78Population: All participants who received at least one dose of study drug, had a baseline and at least one post-baseline value for this outcome. Participants who were assigned treatment by mistake were excluded.
Change from baseline in body weight was reported. LS Mean was determined by MMRM model using BASELINE + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=654 Participants
Participants received 500 U/mL insulin efsitora administered SC QW.
|
100 U/mL - Insulin Degludec
n=330 Participants
Participants received 100 U/mL insulin degludec administered SC QD.
|
|---|---|---|
|
Change From Baseline in Body Weight
|
2.27 kilograms (kg)
Standard Error 0.133
|
2.20 kilograms (kg)
Standard Error 0.186
|
SECONDARY outcome
Timeframe: Week 22 to Week 26Population: All randomized participants who took at least one dose of the study drug and had evaluable data for this outcome at baseline or Week 22-26 were included. Participants who were assigned treatment by mistake were excluded.
Percentage of time in hypoglycemia range with glucose \<54 mg/dL (3.0 mmol/L) measured during CGM from 22-26 weeks. LS Mean was determined using ANCOVA model using Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed with multiple imputation under assumption of missing at random. Missing data at Week 22-26 were imputed by return-to-baseline multiple imputation approach.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=641 Participants
Participants received 500 U/mL insulin efsitora administered SC QW.
|
100 U/mL - Insulin Degludec
n=325 Participants
Participants received 100 U/mL insulin degludec administered SC QD.
|
|---|---|---|
|
Percentage of Time in Hypoglycemia Range
|
0.36 Percentage of time
Standard Error 0.036
|
0.22 Percentage of time
Standard Error 0.051
|
SECONDARY outcome
Timeframe: Week 22 to Week 26Population: All randomized participants who took at least one dose of the study drug and had evaluable data for this outcome at baseline or Week 22-26 were included. Participants who were assigned treatment by mistake were excluded.
Percentage of time in hyperglycemia range with glucose \>180 mg/dL (10.0 mmol/L) measured during the CGM session from 22-26 weeks. LS Mean was determined using ANCOVA model using Baseline + Country + Hemoglobin A1c Stratum at Baseline + Type of Basal Insulin used at Baseline + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed with multiple imputation under assumption of missing at random. Missing data at Week 22-26 were imputed by return-to-baseline multiple imputation approach.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=641 Participants
Participants received 500 U/mL insulin efsitora administered SC QW.
|
100 U/mL - Insulin Degludec
n=325 Participants
Participants received 100 U/mL insulin degludec administered SC QD.
|
|---|---|---|
|
Percentage of Time in Hyperglycemia Range
|
37.25 Percentage of time
Standard Error 0.700
|
38.24 Percentage of time
Standard Error 0.989
|
SECONDARY outcome
Timeframe: Baseline, Week 26, Week 52, Week 78Population: All participants who received at least one dose of the study drug, had a baseline and at least one post-baseline value for this outcome. Participants who were assigned treatment by mistake were excluded.
The TRIM-D is a self-administered instrument, which assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments. The TRIM-D consists of 28 items each assessed on a 5-point scale. TRIM-D items assess 5 domains of impact: * Treatment Burden (6 items) * Daily Life (5 items) * Diabetes Management (5 items) * Compliance (4 items), and * Psychological Health (8 items) Items within each domain are summed to obtain a raw domain score, which is then transformed to a 0-100 scale, where higher scores indicate a greater impact on participant's functioning and well-being. LS mean was determined using MMRM model with BASELINE + Country + Type of Basal Insulin at Baseline + Baseline HbA1C Stratum (%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=625 Participants
Participants received 500 U/mL insulin efsitora administered SC QW.
|
100 U/mL - Insulin Degludec
n=314 Participants
Participants received 100 U/mL insulin degludec administered SC QD.
|
|---|---|---|
|
Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)
Week 26
|
10.03 Score on a scale
Standard Error 0.424
|
6.88 Score on a scale
Standard Error 0.599
|
|
Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)
Week 52
|
10.09 Score on a scale
Standard Error 0.445
|
6.53 Score on a scale
Standard Error 0.627
|
|
Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D)
Week 78
|
10.33 Score on a scale
Standard Error 0.472
|
6.98 Score on a scale
Standard Error 0.662
|
SECONDARY outcome
Timeframe: Week 26Population: All participants who received at least one dose of study drug and had evaluable data for this outcome. Participants who were assigned treatment by mistake were excluded.
DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=599 Participants
Participants received 500 U/mL insulin efsitora administered SC QW.
|
100 U/mL - Insulin Degludec
n=304 Participants
Participants received 100 U/mL insulin degludec administered SC QD.
|
|---|---|---|
|
Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 26
|
14.9 Score on a scale
Standard Deviation 4.47
|
12.3 Score on a scale
Standard Deviation 6.15
|
SECONDARY outcome
Timeframe: Week 52Population: All participants who received at least one dose of study drug and had evaluable data for this outcome. Participants who were assigned treatment by mistake were excluded.
DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=570 Participants
Participants received 500 U/mL insulin efsitora administered SC QW.
|
100 U/mL - Insulin Degludec
n=290 Participants
Participants received 100 U/mL insulin degludec administered SC QD.
|
|---|---|---|
|
Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 52
|
15.1 Score on a scale
Standard Deviation 4.45
|
12.3 Score on a scale
Standard Deviation 6.10
|
SECONDARY outcome
Timeframe: Week 78Population: All participants who received at least one dose of study drug and had evaluable data for this outcome. Participants who were assigned treatment by mistake were excluded.
DTSQc treatment satisfaction score is a 6-item questionnaire which assesses relative change in overall treatment satisfaction. The treatment satisfaction score ranges from -18 to 18, where higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment.
Outcome measures
| Measure |
500 U/mL - Insulin Efsitora
n=523 Participants
Participants received 500 U/mL insulin efsitora administered SC QW.
|
100 U/mL - Insulin Degludec
n=268 Participants
Participants received 100 U/mL insulin degludec administered SC QD.
|
|---|---|---|
|
Diabetes Treatment Satisfaction Questionnaire-Change Version (DTSQc) - Treatment Satisfaction Score: Week 78
|
15.4 Score on a scale
Standard Deviation 4.23
|
11.7 Score on a scale
Standard Deviation 6.61
|
Adverse Events
500 U/mL - Insulin Efsitora
Serious events: 103 serious events
Other events: 241 other events
Deaths: 7 deaths
100 U/mL - Insulin Degludec
Serious events: 37 serious events
Other events: 102 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
500 U/mL - Insulin Efsitora
n=655 participants at risk
Participants received 500 U/mL insulin efsitora administered SC QW.
|
100 U/mL - Insulin Degludec
n=331 participants at risk
Participants received 100 U/mL insulin degludec administered SC QD.
|
|---|---|---|
|
Cardiac disorders
Acute left ventricular failure
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.61%
4/655 • Number of events 4 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
4/331 • Number of events 4 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Angina pectoris
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Angina unstable
|
0.76%
5/655 • Number of events 5 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure
|
0.46%
3/655 • Number of events 3 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.31%
2/655 • Number of events 2 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac valve disease
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiogenic shock
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Chronic coronary syndrome
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery disease
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
4/331 • Number of events 4 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial infarction
|
0.31%
2/655 • Number of events 2 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.27%
1/376 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/179 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Primary hyperthyroidism
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Cataract
|
0.46%
3/655 • Number of events 3 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Diabetic retinopathy
|
0.31%
2/655 • Number of events 2 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Diplopia
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Retinal detachment
|
0.31%
2/655 • Number of events 2 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.15%
1/655 • Number of events 2 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.15%
1/655 • Number of events 3 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Asthenia
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Chest pain
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Death
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Sudden death
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Vascular stent stenosis
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Acute cholecystitis necrotic
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.60%
2/331 • Number of events 2 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.31%
2/655 • Number of events 2 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gangrene
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis viral
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Hcov-oc43 infection
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Hiv infection
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Infective exacerbation of asthma
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Localised infection
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Osteomyelitis
|
0.46%
3/655 • Number of events 3 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Perirectal abscess
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumocystis jirovecii infection
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.46%
3/655 • Number of events 3 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
4/331 • Number of events 4 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Septic shock
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Wound
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Continuous glucose monitoring
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.61%
4/655 • Number of events 5 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.60%
2/331 • Number of events 2 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.31%
2/655 • Number of events 2 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiomyolipoma
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chromophobe renal cell carcinoma
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal adenocarcinoma of pancreas
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/279 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.66%
1/152 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.1%
4/376 • Number of events 4 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/179 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral infarction
|
0.31%
2/655 • Number of events 2 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dural arteriovenous fistula
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Hemiplegia
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.31%
2/655 • Number of events 2 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Ischaemic stroke
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Lacunar infarction
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Myelopathy
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Calculus bladder
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Haematuria
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.31%
2/655 • Number of events 2 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.27%
1/376 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/179 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 2 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.31%
2/655 • Number of events 2 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.31%
2/655 • Number of events 2 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Limb amputation
|
0.15%
1/655 • Number of events 2 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Skin graft
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Aneurysm thrombosis
|
0.00%
0/655 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Aortic stenosis
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Arterial disorder
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Deep vein thrombosis
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Extremity necrosis
|
0.31%
2/655 • Number of events 3 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.31%
2/655 • Number of events 2 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.30%
1/331 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Peripheral ischaemia
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Shock haemorrhagic
|
0.15%
1/655 • Number of events 1 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/331 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
500 U/mL - Insulin Efsitora
n=655 participants at risk
Participants received 500 U/mL insulin efsitora administered SC QW.
|
100 U/mL - Insulin Degludec
n=331 participants at risk
Participants received 100 U/mL insulin degludec administered SC QD.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
35/655 • Number of events 46 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.2%
14/331 • Number of events 23 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
10.7%
70/655 • Number of events 73 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.2%
27/331 • Number of events 28 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
9.2%
60/655 • Number of events 88 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.8%
29/331 • Number of events 36 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.2%
34/655 • Number of events 40 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.4%
18/331 • Number of events 25 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Dose calculation error
|
6.4%
42/655 • Number of events 55 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.5%
15/331 • Number of events 18 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
34/655 • Number of events 39 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.6%
12/331 • Number of events 13 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
33/655 • Number of events 35 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.6%
12/331 • Number of events 12 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
5.5%
36/655 • Number of events 57 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
7/331 • Number of events 9 • Baseline Through Safety Follow-Up (Up to 83 Weeks)
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60