Trial Outcomes & Findings for Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND (NCT NCT05395091)
NCT ID: NCT05395091
Last Updated: 2025-05-29
Results Overview
Percent Change From Baseline in LS BMD at Month 12 to demonstrate comparable efficacy of AVT03 and Prolia®.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
532 participants
Primary outcome timeframe
Baseline to Month 12
Results posted on
2025-05-29
Participant Flow
Participant milestones
| Measure |
AVT03
AVT03 is a proposed biosimilar for Prolia.
AVT03: AVT03 (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL to be administered as a subcutaneous injection. Subjects in this arm will receive AVT03 60mg administered s.c. on Day 1 and at Month 6. At Month 12, subjects in the AVT03 arm will receive a third dose of AVT03 60 mg.
|
Prolia
Denosumab: Prolia (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL developed to be administered as a subcutaneous injection.
Subjects will receive 60mg of commercially available US-Prolia, administered s.c on Day 1 and Month 6. At Month 12, subjects in the Prolia treatment group will be re-randomized in a 1:1 ratio to receive either:
* AVT03 60 mg administered s.c. on Day365.
* Prolia 60 mg administered s.c. on Day365.
|
Prolia/AVT03 (Month 12 to Month18)
Participants re-randomized on Month 12 from Prolia to AVT03 arm
|
|---|---|---|---|
|
Baseline to Month 12
STARTED
|
266
|
266
|
0
|
|
Baseline to Month 12
COMPLETED
|
242
|
244
|
0
|
|
Baseline to Month 12
NOT COMPLETED
|
24
|
22
|
0
|
|
Month 12 to Month 18
STARTED
|
242
|
122
|
122
|
|
Month 12 to Month 18
COMPLETED
|
237
|
120
|
119
|
|
Month 12 to Month 18
NOT COMPLETED
|
5
|
2
|
3
|
Reasons for withdrawal
| Measure |
AVT03
AVT03 is a proposed biosimilar for Prolia.
AVT03: AVT03 (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL to be administered as a subcutaneous injection. Subjects in this arm will receive AVT03 60mg administered s.c. on Day 1 and at Month 6. At Month 12, subjects in the AVT03 arm will receive a third dose of AVT03 60 mg.
|
Prolia
Denosumab: Prolia (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL developed to be administered as a subcutaneous injection.
Subjects will receive 60mg of commercially available US-Prolia, administered s.c on Day 1 and Month 6. At Month 12, subjects in the Prolia treatment group will be re-randomized in a 1:1 ratio to receive either:
* AVT03 60 mg administered s.c. on Day365.
* Prolia 60 mg administered s.c. on Day365.
|
Prolia/AVT03 (Month 12 to Month18)
Participants re-randomized on Month 12 from Prolia to AVT03 arm
|
|---|---|---|---|
|
Baseline to Month 12
Adverse Event
|
7
|
2
|
0
|
|
Baseline to Month 12
Death
|
3
|
1
|
0
|
|
Baseline to Month 12
Withdrawal by Subject
|
11
|
16
|
0
|
|
Baseline to Month 12
Protocol Violation
|
2
|
3
|
0
|
|
Baseline to Month 12
Physician Decision
|
1
|
0
|
0
|
|
Month 12 to Month 18
Death
|
1
|
0
|
0
|
|
Month 12 to Month 18
Withdrawal by Subject
|
3
|
2
|
1
|
|
Month 12 to Month 18
Lost to Follow-up
|
1
|
0
|
1
|
|
Month 12 to Month 18
Other reasons
|
0
|
0
|
1
|
Baseline Characteristics
Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND
Baseline characteristics by cohort
| Measure |
AVT03
n=266 Participants
AVT03 is a proposed biosimilar for Prolia.
AVT03: AVT03 (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL to be administered as a subcutaneous injection. Subjects in this arm received AVT03 60mg administered s.c. on Day 1 and at Month 6. At Month 12, subjects in the AVT03 arm received a third dose of AVT03 60 mg.
|
Prolia
n=266 Participants
Denosumab: Prolia (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL developed to be administered as a subcutaneous injection.
Subjects will receive 60mg of commercially available US-Prolia, administered s.c on Day 1 and at Month 6. At Month 12, subjects in the Prolia treatment group will be re-randomized in a 1:1 ratio to receive either:
* AVT03 60 mg administered s.c. on Day365.
* Prolia 60 mg administered s.c. on Day365.
|
Total
n=532 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 6.94 • n=5 Participants
|
64.5 years
STANDARD_DEVIATION 7.04 • n=7 Participants
|
64.9 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
266 Participants
n=5 Participants
|
266 Participants
n=7 Participants
|
532 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
246 Participants
n=5 Participants
|
249 Participants
n=7 Participants
|
495 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
28 participants
n=5 Participants
|
33 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
144 participants
n=5 Participants
|
144 participants
n=7 Participants
|
288 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
47 participants
n=5 Participants
|
41 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
Region of Enrollment
Georgia
|
33 participants
n=5 Participants
|
37 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
BMI at screening
|
25.12 kg/m^2
STANDARD_DEVIATION 3.547 • n=5 Participants
|
25.2 kg/m^2
STANDARD_DEVIATION 3.605 • n=7 Participants
|
25.16 kg/m^2
STANDARD_DEVIATION 3.573 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 12Population: The number of evaluable subjects with data at Month 12 per group.
Percent Change From Baseline in LS BMD at Month 12 to demonstrate comparable efficacy of AVT03 and Prolia®.
Outcome measures
| Measure |
AVT03
n=239 Participants
AVT03 is the proposed biosimilar for Prolia.
AVT03: AVT03 (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL to be administered as a subcutaneous injection. Subjects in this arm received AVT03 60mg administered s.c. on Day 1 and at Month 6. At Month 12, subjects in the AVT03 arm received a third dose of AVT03 60 mg.
|
Prolia
n=237 Participants
Denosumab: Prolia (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL developed to be administered as a subcutaneous injection.
Subjects received 60mg of commercially available US-Prolia, administered s.c. on Day 1 and at Month 6. At Month 12, subjects in the Prolia treatment group were re-randomized in a 1:1 ratio to receive either:
* Group 2a: Subjects will receive AVT03 60 mg administered s.c. on Day365.
* Group 2b: Subjects will receive Prolia 60 mg administered s.c. on Day365.
|
|---|---|---|
|
Percent Change From Baseline in LS BMD at Month 12 to Demonstrate Comparable Efficacy of AVT03 and Prolia®.
|
5.3 Percent Change From Baseline in LS BMD
Standard Error 0.870
|
5.18 Percent Change From Baseline in LS BMD
Standard Error 0.872
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: The number of evaluable subjects with data at Month 12 per group.
Outcome measures
| Measure |
AVT03
n=243 Participants
AVT03 is the proposed biosimilar for Prolia.
AVT03: AVT03 (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL to be administered as a subcutaneous injection. Subjects in this arm received AVT03 60mg administered s.c. on Day 1 and at Month 6. At Month 12, subjects in the AVT03 arm received a third dose of AVT03 60 mg.
|
Prolia
n=248 Participants
Denosumab: Prolia (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL developed to be administered as a subcutaneous injection.
Subjects received 60mg of commercially available US-Prolia, administered s.c. on Day 1 and at Month 6. At Month 12, subjects in the Prolia treatment group were re-randomized in a 1:1 ratio to receive either:
* Group 2a: Subjects will receive AVT03 60 mg administered s.c. on Day365.
* Group 2b: Subjects will receive Prolia 60 mg administered s.c. on Day365.
|
|---|---|---|
|
To Demonstrate Comparable Profile of AVT03 and Prolia in Terms of Area Under the Percent Change From Baseline in Serum C-telopeptide of Type 1 Collagen (AUEC of %Cfb sCTX-1)
|
2345.55 percentage change from baseline*days
Standard Error 1.011
|
2342.87 percentage change from baseline*days
Standard Error 1.011
|
SECONDARY outcome
Timeframe: Month 6, Month18Percent change from Baseline in LS BMD at 6 and 18 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 6, Month 12, Month 18Percent change from Baseline in hip and femoral neck BMD at Month 6, 12 and 18 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12 and 18Incidence of new morphometric vertebral fractures at 12 and 18 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 9, Month 12 and Month 18Percent change from Baseline in sCTX-1 at 3, 6, 9, 12 and 18 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 18Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 12Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 18Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 18Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 18Outcome measures
Outcome data not reported
Adverse Events
AVT03 (Baseline to Month 12)
Serious events: 9 serious events
Other events: 178 other events
Deaths: 3 deaths
Prolia (Baseline to Month 12)
Serious events: 10 serious events
Other events: 178 other events
Deaths: 1 deaths
AVT03 (Month 12 to Month18)
Serious events: 6 serious events
Other events: 99 other events
Deaths: 1 deaths
Prolia/AVT03 (Month 12 to Month18)
Serious events: 3 serious events
Other events: 39 other events
Deaths: 0 deaths
Prolia/Prolia (Month 12 to Month18)
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AVT03 (Baseline to Month 12)
n=266 participants at risk
Randomized on Baseline to AVT03
|
Prolia (Baseline to Month 12)
n=266 participants at risk
Randomized on Baseline to Prolia
|
AVT03 (Month 12 to Month18)
n=242 participants at risk
Continuation on AVT03.
|
Prolia/AVT03 (Month 12 to Month18)
n=122 participants at risk
Re-randomized on Month 12 to AVT03
|
Prolia/Prolia (Month 12 to Month18)
n=122 participants at risk
Re-randomized on Month 12 to Prolia
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Cardiac disorders
Chronic coronary syndrome
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Eye disorders
Diplopia
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Pancreatitis
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
General disorders
Death
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
General disorders
Sudden death
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Infections and infestations
Appendicitis
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Infections and infestations
Infective myositis
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Pneumonia
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Soft tissue infection
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of bone
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Renal and urinary disorders
Renal failure
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Reproductive system and breast disorders
Genital prolapse
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Vascular disorders
Hypertension
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
Other adverse events
| Measure |
AVT03 (Baseline to Month 12)
n=266 participants at risk
Randomized on Baseline to AVT03
|
Prolia (Baseline to Month 12)
n=266 participants at risk
Randomized on Baseline to Prolia
|
AVT03 (Month 12 to Month18)
n=242 participants at risk
Continuation on AVT03.
|
Prolia/AVT03 (Month 12 to Month18)
n=122 participants at risk
Re-randomized on Month 12 to AVT03
|
Prolia/Prolia (Month 12 to Month18)
n=122 participants at risk
Re-randomized on Month 12 to Prolia
|
|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Blood and lymphatic system disorders
Abnormal clotting factor
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
7/266 • Number of events 8 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.1%
3/266 • Number of events 3 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Blood and lymphatic system disorders
Macrocytosis
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Cardiac disorders
Angina pectoris
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Cardiac disorders
Bradycardia
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Cardiac disorders
Chronic coronary syndrome
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Cardiac disorders
Heart failure with preserved ejection fraction
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Cardiac disorders
Palpitations
|
0.38%
1/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/266 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Congenital, familial and genetic disorders
Factor XII deficiency
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Ear and labyrinth disorders
Ear inflammation
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Ear and labyrinth disorders
Tinnitus
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Ear and labyrinth disorders
Vertigo
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Endocrine disorders
Goitre
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Eye disorders
Blepharitis
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Eye disorders
Cataract
|
0.00%
0/266 • From baseline to Month 18
|
1.1%
3/266 • Number of events 3 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Eye disorders
Chalazion
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Eye disorders
Eye haematoma
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Eye disorders
Eye inflammation
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Eye disorders
Eye pain
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Eye disorders
Posterior capsule opacification
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Eye disorders
Pseudophakia
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Eye disorders
Retinal vein thrombosis
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Abdominal pain
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
3/266 • Number of events 3 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Cascade stomach
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Constipation
|
1.1%
3/266 • Number of events 3 • From baseline to Month 18
|
3.0%
8/266 • Number of events 8 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Dental caries
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
6/266 • Number of events 11 • From baseline to Month 18
|
1.5%
4/266 • Number of events 5 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
3/266 • Number of events 3 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Food poisoning
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Gastric mucosa erythema
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Gastritis
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.1%
3/266 • Number of events 4 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
1.6%
2/122 • Number of events 2 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Intestinal barrier dysfunction
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Nausea
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
3.0%
8/266 • Number of events 8 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Oral discomfort
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Rectal polyp
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
General disorders
Asthenia
|
1.5%
4/266 • Number of events 4 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
General disorders
Fatigue
|
0.75%
2/266 • Number of events 3 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
General disorders
Feeling cold
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
General disorders
Influenza like illness
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
General disorders
Injection site reaction
|
3.8%
10/266 • Number of events 10 • From baseline to Month 18
|
3.0%
8/266 • Number of events 10 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.82%
1/122 • Number of events 2 • From baseline to Month 18
|
|
General disorders
Malaise
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
General disorders
Non-cardiac chest pain
|
0.38%
1/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
General disorders
Oedema peripheral
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
General disorders
Peripheral swelling
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Hepatobiliary disorders
Hepatic calcification
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.75%
2/266 • Number of events 3 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Hepatobiliary disorders
Liver disorder
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Hepatobiliary disorders
Metabolic dysfunction-associated liver disease
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Immune system disorders
Seasonal allergy
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Bronchitis
|
3.4%
9/266 • Number of events 9 • From baseline to Month 18
|
1.1%
3/266 • Number of events 3 • From baseline to Month 18
|
0.83%
2/242 • Number of events 3 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
COVID-19
|
2.6%
7/266 • Number of events 7 • From baseline to Month 18
|
1.5%
4/266 • Number of events 4 • From baseline to Month 18
|
0.83%
2/242 • Number of events 2 • From baseline to Month 18
|
1.6%
2/122 • Number of events 2 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Candida infection
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Conjunctivitis
|
1.1%
3/266 • Number of events 3 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Cystitis
|
2.6%
7/266 • Number of events 7 • From baseline to Month 18
|
0.75%
2/266 • Number of events 3 • From baseline to Month 18
|
1.2%
3/242 • Number of events 3 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Infections and infestations
Diarrhoea infectious
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Erysipelas
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Folliculitis
|
0.38%
1/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Gastroenteritis
|
1.1%
3/266 • Number of events 3 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Gingivitis
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Helicobacter infection
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Herpes virus infection
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
1.6%
2/122 • Number of events 2 • From baseline to Month 18
|
|
Infections and infestations
Herpes zoster
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
1.1%
3/266 • Number of events 3 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Hordeolum
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Influenza
|
3.0%
8/266 • Number of events 9 • From baseline to Month 18
|
4.1%
11/266 • Number of events 12 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Labyrinthitis
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Laryngitis
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Lower respiratory tract infection
|
0.75%
2/266 • Number of events 4 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.83%
2/242 • Number of events 2 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
23/266 • Number of events 25 • From baseline to Month 18
|
7.5%
20/266 • Number of events 23 • From baseline to Month 18
|
3.7%
9/242 • Number of events 9 • From baseline to Month 18
|
2.5%
3/122 • Number of events 3 • From baseline to Month 18
|
1.6%
2/122 • Number of events 2 • From baseline to Month 18
|
|
Infections and infestations
Oral candidiasis
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Oral herpes
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
1.1%
3/266 • Number of events 3 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Infections and infestations
Oral infection
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Otitis media
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Pharyngitis
|
1.5%
4/266 • Number of events 4 • From baseline to Month 18
|
1.9%
5/266 • Number of events 5 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Pneumonia
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.83%
2/242 • Number of events 2 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Rhinitis
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
1.1%
3/266 • Number of events 3 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Sinusitis
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
1.1%
3/266 • Number of events 3 • From baseline to Month 18
|
0.83%
2/242 • Number of events 2 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Sinusitis bacterial
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Tonsillitis bacterial
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Tooth abscess
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Tooth infection
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.83%
2/242 • Number of events 2 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Upper respiratory tract infection
|
12.0%
32/266 • Number of events 37 • From baseline to Month 18
|
13.5%
36/266 • Number of events 44 • From baseline to Month 18
|
2.9%
7/242 • Number of events 8 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
6.6%
8/122 • Number of events 8 • From baseline to Month 18
|
|
Infections and infestations
Urinary tract infection
|
5.3%
14/266 • Number of events 16 • From baseline to Month 18
|
1.9%
5/266 • Number of events 6 • From baseline to Month 18
|
1.2%
3/242 • Number of events 3 • From baseline to Month 18
|
2.5%
3/122 • Number of events 3 • From baseline to Month 18
|
2.5%
3/122 • Number of events 3 • From baseline to Month 18
|
|
Infections and infestations
Viral infection
|
1.5%
4/266 • Number of events 4 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Contusion
|
1.1%
3/266 • Number of events 3 • From baseline to Month 18
|
1.5%
4/266 • Number of events 4 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Dental restoration failure
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.83%
2/242 • Number of events 2 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/266 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.83%
2/242 • Number of events 2 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.38%
1/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
1.1%
3/266 • Number of events 3 • From baseline to Month 18
|
1.1%
3/266 • Number of events 3 • From baseline to Month 18
|
2.5%
6/242 • Number of events 6 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
1.6%
2/122 • Number of events 3 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Traumatic pain
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.9%
13/266 • Number of events 13 • From baseline to Month 18
|
5.6%
15/266 • Number of events 16 • From baseline to Month 18
|
3.3%
8/242 • Number of events 8 • From baseline to Month 18
|
2.5%
3/122 • Number of events 4 • From baseline to Month 18
|
4.9%
6/122 • Number of events 6 • From baseline to Month 18
|
|
Investigations
Adjusted calcium decreased
|
5.3%
14/266 • Number of events 15 • From baseline to Month 18
|
2.3%
6/266 • Number of events 6 • From baseline to Month 18
|
3.3%
8/242 • Number of events 8 • From baseline to Month 18
|
3.3%
4/122 • Number of events 4 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Adjusted calcium increased
|
0.00%
0/266 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Investigations
Alanine aminotransferase increased
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Investigations
Aspartate aminotransferase increased
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Investigations
Blood calcium decreased
|
0.00%
0/266 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Blood creatine increased
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Blood creatinine increased
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Investigations
Blood pressure increased
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
1.1%
3/266 • Number of events 4 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Calcium ionised decreased
|
2.6%
7/266 • Number of events 8 • From baseline to Month 18
|
2.6%
7/266 • Number of events 8 • From baseline to Month 18
|
2.5%
6/242 • Number of events 6 • From baseline to Month 18
|
2.5%
3/122 • Number of events 4 • From baseline to Month 18
|
1.6%
2/122 • Number of events 2 • From baseline to Month 18
|
|
Investigations
Cardiac murmur
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Coagulation factor increased
|
0.00%
0/266 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Creatinine renal clearance decreased
|
1.5%
4/266 • Number of events 5 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Creatinine renal clearance increased
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Electrocardiogram T wave inversion
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Glomerular filtration rate decreased
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Haematocrit increased
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/266 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Haemoglobin increased
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Hepatitis B core antibody positive
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
International normalised ratio increased
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Investigations
Liver function test increased
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Protein urine present
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
Red blood cell count increased
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
White blood cell count decreased
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Investigations
White blood cells urine positive
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Metabolism and nutrition disorders
Dehydration
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/266 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.75%
2/266 • Number of events 4 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.83%
2/242 • Number of events 2 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.5%
28/266 • Number of events 34 • From baseline to Month 18
|
8.6%
23/266 • Number of events 28 • From baseline to Month 18
|
2.1%
5/242 • Number of events 5 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
2.5%
3/122 • Number of events 3 • From baseline to Month 18
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Metabolism and nutrition disorders
Impaired fasting glucose
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
10/266 • Number of events 16 • From baseline to Month 18
|
3.4%
9/266 • Number of events 11 • From baseline to Month 18
|
1.2%
3/242 • Number of events 3 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.83%
2/242 • Number of events 2 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
1.9%
5/266 • Number of events 5 • From baseline to Month 18
|
0.75%
2/266 • Number of events 3 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.5%
4/266 • Number of events 4 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
1.5%
4/266 • Number of events 4 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.3%
6/266 • Number of events 7 • From baseline to Month 18
|
2.6%
7/266 • Number of events 7 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.75%
2/266 • Number of events 3 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.3%
6/266 • Number of events 6 • From baseline to Month 18
|
1.5%
4/266 • Number of events 5 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
6/266 • Number of events 9 • From baseline to Month 18
|
1.9%
5/266 • Number of events 5 • From baseline to Month 18
|
0.41%
1/242 • Number of events 2 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
1.1%
3/266 • Number of events 4 • From baseline to Month 18
|
1.1%
3/266 • Number of events 4 • From baseline to Month 18
|
0.83%
2/242 • Number of events 2 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of bone
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Nervous system disorders
Arachnoid cyst
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Nervous system disorders
Dizziness
|
2.3%
6/266 • Number of events 6 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Nervous system disorders
Headache
|
3.8%
10/266 • Number of events 11 • From baseline to Month 18
|
3.4%
9/266 • Number of events 9 • From baseline to Month 18
|
0.83%
2/242 • Number of events 2 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Nervous system disorders
Hypoaesthesia
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Nervous system disorders
Neuropathy peripheral
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Nervous system disorders
Sciatica
|
1.5%
4/266 • Number of events 4 • From baseline to Month 18
|
1.1%
3/266 • Number of events 3 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
1.6%
2/122 • Number of events 2 • From baseline to Month 18
|
|
Nervous system disorders
Syncope
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Nervous system disorders
Tension headache
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Psychiatric disorders
Depressed mood
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Psychiatric disorders
Depression
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Psychiatric disorders
Insomnia
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Psychiatric disorders
Major depression
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.75%
2/266 • Number of events 3 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Renal and urinary disorders
Dysuria
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Renal and urinary disorders
Glycosuria
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Renal and urinary disorders
Haematuria
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Renal and urinary disorders
Leukocyturia
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Renal and urinary disorders
Proteinuria
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.41%
1/242 • Number of events 2 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Renal and urinary disorders
Renal cyst
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Renal and urinary disorders
Renal failure
|
0.75%
2/266 • Number of events 3 • From baseline to Month 18
|
1.1%
3/266 • Number of events 4 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Renal and urinary disorders
Urinary tract inflammation
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Reproductive system and breast disorders
Genital prolapse
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/266 • From baseline to Month 18
|
1.5%
4/266 • Number of events 4 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus inflammation
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.75%
2/266 • Number of events 3 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.75%
2/266 • Number of events 3 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/266 • From baseline to Month 18
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.41%
1/242 • Number of events 1 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Skin and subcutaneous tissue disorders
Urticaria chronic
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Vascular disorders
Haematoma
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Vascular disorders
Hypertension
|
4.5%
12/266 • Number of events 13 • From baseline to Month 18
|
3.0%
8/266 • Number of events 8 • From baseline to Month 18
|
0.83%
2/242 • Number of events 2 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
1.6%
2/122 • Number of events 2 • From baseline to Month 18
|
|
Vascular disorders
Hypotension
|
0.75%
2/266 • Number of events 2 • From baseline to Month 18
|
0.00%
0/266 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.82%
1/122 • Number of events 1 • From baseline to Month 18
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/266 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
|
Vascular disorders
Varicose vein
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.38%
1/266 • Number of events 1 • From baseline to Month 18
|
0.00%
0/242 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
0.00%
0/122 • From baseline to Month 18
|
Additional Information
Clinical Development and Medical Lead
Alvotech Swiss AG
Phone: +41 78 659 89 89
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER