Trial Outcomes & Findings for Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy (NCT NCT04469270)
NCT ID: NCT04469270
Last Updated: 2025-10-09
Results Overview
• The Brief Pain Inventory for Participants with Diabetic Peripheral Neuropathy has a minimum score of 0 and a maximum score of 10, with a higher score representing a worse outcome of more pain. Change in Baseline to Day 180. Summary of the Actual Value of the Change from Baseline to Day 180 in Average Daily Pain Score (Intent-To-Treat Population). Overall Engensis n=79.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
162 participants
Primary outcome timeframe
180 days
Results posted on
2025-10-09
Participant Flow
Participant milestones
| Measure |
Engensis
16 (ea) 0.25mg (0.5 mL) injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Engensis: Intramuscular injections
|
Placebo
16 0.5 mL injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Placebo: Intramuscular injections
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
81
|
|
Overall Study
COMPLETED
|
65
|
75
|
|
Overall Study
NOT COMPLETED
|
16
|
6
|
Reasons for withdrawal
| Measure |
Engensis
16 (ea) 0.25mg (0.5 mL) injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Engensis: Intramuscular injections
|
Placebo
16 0.5 mL injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Placebo: Intramuscular injections
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
7
|
3
|
|
Overall Study
Not Dosed - 2 subjects misrandomized, included in ITT, but not Safety population.
|
2
|
0
|
|
Overall Study
missing
|
1
|
0
|
Baseline Characteristics
Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
Engensis
n=81 Participants
16 (ea) 0.25mg (0.5 mL) injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Engensis: Intramuscular injections
|
Placebo
n=81 Participants
16 0.5 mL injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Placebo: Intramuscular injections
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
98 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 9.46 • n=93 Participants
|
61.0 years
STANDARD_DEVIATION 10.25 • n=4 Participants
|
61.8 years
STANDARD_DEVIATION 9.87 • n=27 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=93 Participants
|
56 Participants
n=4 Participants
|
114 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
139 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=93 Participants
|
81 participants
n=4 Participants
|
162 participants
n=27 Participants
|
|
BMI (kg/m^2)
|
32.533 kg/m^2
STANDARD_DEVIATION 5.2182 • n=93 Participants
|
31.440 kg/m^2
STANDARD_DEVIATION 4.7049 • n=4 Participants
|
31.987 kg/m^2
STANDARD_DEVIATION 4.9830 • n=27 Participants
|
PRIMARY outcome
Timeframe: 180 daysPopulation: Summary of the Actual Value of the Change from Baseline to Day 180. 81 subjects were randomized to Engensis. Two Engensis subjects were never dosed and were withdrawn from the study on Day 0, therefore do not fall into the safety population.
• The Brief Pain Inventory for Participants with Diabetic Peripheral Neuropathy has a minimum score of 0 and a maximum score of 10, with a higher score representing a worse outcome of more pain. Change in Baseline to Day 180. Summary of the Actual Value of the Change from Baseline to Day 180 in Average Daily Pain Score (Intent-To-Treat Population). Overall Engensis n=79.
Outcome measures
| Measure |
Engensis
n=79 Participants
16 (ea) 0.25mg (0.5 mL) injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Engensis: Intramuscular injections
|
Placebo
n=81 Participants
16 0.5 mL injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Placebo: Intramuscular injections
|
|---|---|---|
|
Efficacy of Engensis Compared to Placebo Painful Diabetic Peripheral Neuropathy in Feet and Lower Legs Comparing Average Daily Pain Score From Day 0 Visit to Day 180 Visit on Brief Pain Inventory for Participants With Diabetic Peripheral Neuropathy
|
-2.03 score on a scale
Standard Deviation 2.020
|
-2.69 score on a scale
Standard Deviation 2.115
|
SECONDARY outcome
Timeframe: 180 daysPopulation: Summary of the Actual Value of the Change from Baseline to Day 180 in Worst Pain Score (Intent-To-Treat Population). 81 subjects were randomized to Engensis. Two Engensis subjects were never dosed and were withdrawn from the study on Day 0, therefore do not fall into the safety population. Overall Engensis n=79.
• The Brief Pain Inventory for Diabetic Peripheral Neuropathy has a minimum score of 0 and a maximum score of 10, with a higher score representing a worse outcome of more pain. Summary of the Actual Value of the Change from Baseline to Day 180 in Worst Pain Score (Intent-To-Treat Population).
Outcome measures
| Measure |
Engensis
n=79 Participants
16 (ea) 0.25mg (0.5 mL) injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Engensis: Intramuscular injections
|
Placebo
n=81 Participants
16 0.5 mL injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Placebo: Intramuscular injections
|
|---|---|---|
|
Efficacy of Engensis on Worst Pain in Painful Diabetic Peripheral Neuropathy in Feet and Legs by Comparing Change From Baseline (Day 0) in Worst Pain Score From Brief Pain Inventory for Diabetic Peripheral Neuropathy to Day 180 Compared to Placebo
|
-2.10 score on a scale
Standard Deviation 2.374
|
-3.06 score on a scale
Standard Deviation 2.588
|
SECONDARY outcome
Timeframe: 180 daysPopulation: Responders with ≥50% Reduction from Baseline in the Average Daily Pain Score on Day 180 (Intent-To-Treat Population). 81 subjects were randomized to Engensis. Two Engensis subjects were never dosed and were withdrawn from the study on Day 0, therefore do not fall into the safety population. Overall Engensis n=79.
• The Average Daily Pain Score from the Brief Pain Inventory for Participants with Diabetic Peripheral Neuropathy has a minimum score of 0 and a maximum score of 10 with a higher score representing a worse outcome of more pain. Summary of Responders with ≥50% Reduction from Baseline in the Average Daily Pain Score on Day 180 (Intent-To-Treat Population).
Outcome measures
| Measure |
Engensis
n=79 Participants
16 (ea) 0.25mg (0.5 mL) injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Engensis: Intramuscular injections
|
Placebo
n=81 Participants
16 0.5 mL injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Placebo: Intramuscular injections
|
|---|---|---|
|
Efficacy of Engensis Reducing Painful Diabetic Peripheral Neuropathy in Feet and Legs by Determining a ≥ 50% Reduction in the Average Daily Pain Score From Baseline to Day 180 Using the Brief Pain Inventory With Participants Diabetic Peripheral Neuropathy
|
24 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: Overall Summary of Incidence of Treatment-Emergent Adverse Events (Safety Population) by Severity, Incidence of Injection Site Reactions, and Incidence of Clinically Significant Laboratory Values. 81 subjects were randomized to Engensis, Two Engensis subjects were never dosed and were withdrawn from the study on Day 0, therefore do not fall into the safety population. Overall Engensis n = 79.
To evaluate the safety of intramuscular administration of Engensis in Participants with painful diabetic peripheral neuropathy in the feet and lower legs as compared to Placebo. • Incidence of adverse events and serious adverse event; Incidence of injection site reactions; Incidence of clinically significant laboratory values.
Outcome measures
| Measure |
Engensis
n=79 Participants
16 (ea) 0.25mg (0.5 mL) injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Engensis: Intramuscular injections
|
Placebo
n=81 Participants
16 0.5 mL injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Placebo: Intramuscular injections
|
|---|---|---|
|
Safety of Engensis in Painful Diabetic Peripheral Neuropathy in Feet and Legs Comparing Incidence of Adverse and Serious Adverse Events, Incidence of Injection Site Reactions, and Incidence of Clinically Significant Laboratory Values to Placebo
Any Treatment Emergent AE
|
45 Participants
|
44 Participants
|
|
Safety of Engensis in Painful Diabetic Peripheral Neuropathy in Feet and Legs Comparing Incidence of Adverse and Serious Adverse Events, Incidence of Injection Site Reactions, and Incidence of Clinically Significant Laboratory Values to Placebo
Treatment Emergent AE by Severity - Mild
|
18 Participants
|
24 Participants
|
|
Safety of Engensis in Painful Diabetic Peripheral Neuropathy in Feet and Legs Comparing Incidence of Adverse and Serious Adverse Events, Incidence of Injection Site Reactions, and Incidence of Clinically Significant Laboratory Values to Placebo
Treatment Emergent AE by Severity - Moderate
|
20 Participants
|
17 Participants
|
|
Safety of Engensis in Painful Diabetic Peripheral Neuropathy in Feet and Legs Comparing Incidence of Adverse and Serious Adverse Events, Incidence of Injection Site Reactions, and Incidence of Clinically Significant Laboratory Values to Placebo
Treatment Emergent AE by Severity - Severe
|
7 Participants
|
3 Participants
|
|
Safety of Engensis in Painful Diabetic Peripheral Neuropathy in Feet and Legs Comparing Incidence of Adverse and Serious Adverse Events, Incidence of Injection Site Reactions, and Incidence of Clinically Significant Laboratory Values to Placebo
Injection Site Reactions
|
10 Participants
|
9 Participants
|
|
Safety of Engensis in Painful Diabetic Peripheral Neuropathy in Feet and Legs Comparing Incidence of Adverse and Serious Adverse Events, Incidence of Injection Site Reactions, and Incidence of Clinically Significant Laboratory Values to Placebo
Clinically Significant Lab Values - Any Abnormal Analyte Value of Interest
|
29 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 104 daysPopulation: Change from baseline in the TNF-alpha, IL-1b, IFNy, IL-6, IL-4, IL-10, and IL-12 p70 cytokine profile post-dose at the Day 104 visit. Of the 79 Engensis Subjects that were dosed, 69 had Cytokine Samples collected at both Day 0 and Day 104. Of the 81 Placebo Subjects that were dosed, 77 had Cytokine Samples collected at both Day 0 and Day 104.
Change from baseline in the TNF-alpha, IL-1b, IFNy, IL-6, IL-4, IL-10, and IL-12p70 cytokine profile post-dose at the Day 104 visit.
Outcome measures
| Measure |
Engensis
n=69 Participants
16 (ea) 0.25mg (0.5 mL) injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Engensis: Intramuscular injections
|
Placebo
n=77 Participants
16 0.5 mL injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Placebo: Intramuscular injections
|
|---|---|---|
|
To Evaluate the Possibility of Cellular Responses to Engensis
TNF-alpha - Change from Baseline Day 104
|
-0.334 ng/L
Standard Deviation 4.5971
|
0.518 ng/L
Standard Deviation 1.8213
|
|
To Evaluate the Possibility of Cellular Responses to Engensis
IL-6 - Change from Baseline Day 104
|
-0.262 ng/L
Standard Deviation 1.6692
|
0.012 ng/L
Standard Deviation 0.6282
|
|
To Evaluate the Possibility of Cellular Responses to Engensis
IL-1beta - Change from Baseline Day 104
|
-0.245 ng/L
Standard Deviation 2.0345
|
-0.001 ng/L
Standard Deviation 0.0125
|
|
To Evaluate the Possibility of Cellular Responses to Engensis
IF-gamma - Change from Baseline Day 104
|
-3.371 ng/L
Standard Deviation 27.8190
|
1.087 ng/L
Standard Deviation 5.4897
|
|
To Evaluate the Possibility of Cellular Responses to Engensis
IL-4 - Change from Baseline Day 104
|
-0.002 ng/L
Standard Deviation 0.0157
|
0.0 ng/L
Standard Deviation 0.0
|
|
To Evaluate the Possibility of Cellular Responses to Engensis
IL-10 - Change from Baseline Day 104
|
0.147 ng/L
Standard Deviation 1.2292
|
0.029 ng/L
Standard Deviation 0.1439
|
|
To Evaluate the Possibility of Cellular Responses to Engensis
IL-12 - Change from Baseline Day 104
|
0.0 ng/L
Standard Deviation 0.0
|
0.0 ng/L
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Days 0, 60, 90, 150 and 180Population: Safety Population. 81 subjects were randomized to Engensis. Two Engensis subjects were never dosed and were withdrawn from the study on Day 0, therefore do not fall into the safety population. Overall Engensis n=79.
• Presence of anti-hepatocyte growth factor antibodies following Engensis administration compared to Placebo \- Anti-hepatocyte growth factor antibodies will be collected on Day 0, 60, 90, 150 and 180, and the presence will be summarized according to each time point.
Outcome measures
| Measure |
Engensis
n=79 Participants
16 (ea) 0.25mg (0.5 mL) injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Engensis: Intramuscular injections
|
Placebo
n=81 Participants
16 0.5 mL injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Placebo: Intramuscular injections
|
|---|---|---|
|
To Evaluate the Possibility of Humoral Responses to Engensis - Anti-Hepatic Growth Factor
Day 0 - Anti-HGF Present
|
0 Participants
|
0 Participants
|
|
To Evaluate the Possibility of Humoral Responses to Engensis - Anti-Hepatic Growth Factor
Day 60 - Anti-HGF Present
|
0 Participants
|
0 Participants
|
|
To Evaluate the Possibility of Humoral Responses to Engensis - Anti-Hepatic Growth Factor
Day 90 - AntiHGF Present
|
1 Participants
|
0 Participants
|
|
To Evaluate the Possibility of Humoral Responses to Engensis - Anti-Hepatic Growth Factor
Day 150 - AntiHGF Present
|
0 Participants
|
1 Participants
|
|
To Evaluate the Possibility of Humoral Responses to Engensis - Anti-Hepatic Growth Factor
Day 180 - AntiHGF Present
|
0 Participants
|
0 Participants
|
Adverse Events
Engensis
Serious events: 7 serious events
Other events: 38 other events
Deaths: 1 deaths
Placebo
Serious events: 4 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Engensis
n=79 participants at risk
16 (ea) 0.25mg (0.5 mL) injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Engensis: Intramuscular injections
|
Placebo
n=81 participants at risk
16 0.5 mL injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Placebo: Intramuscular injections
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Cardiac disorders
Cardiac failure acute
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Cardiac disorders
Pericardial effusion
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Cardiac disorders
Tachycardia
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Gastrointestinal disorders
Enteritis
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Gastrointestinal disorders
Cyclic vomiting syndrome
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
General disorders
Sudden cardiac death
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Nervous system disorders
Syncope
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Psychiatric disorders
Depression
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
Other adverse events
| Measure |
Engensis
n=79 participants at risk
16 (ea) 0.25mg (0.5 mL) injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Engensis: Intramuscular injections
|
Placebo
n=81 participants at risk
16 0.5 mL injections in each of the right and left gastrocnemius muscles on Days 0, 14, 90, and 104.
Placebo: Intramuscular injections
|
|---|---|---|
|
Infections and infestations
COVID-19
|
5.1%
4/79 • Number of events 4 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
4.9%
4/81 • Number of events 4 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Infections and infestations
Influenza
|
5.1%
4/79 • Number of events 4 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
3.7%
3/81 • Number of events 3 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Infections and infestations
Bronchitis
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Infections and infestations
Rhinitis
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
2.5%
2/81 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Infections and infestations
Sinusitis
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
2.5%
2/81 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Infections and infestations
Chronic Sinusitis
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Infections and infestations
Ear infection
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Infections and infestations
Folliculitis
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Infections and infestations
Pneumonia
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Infections and infestations
Wound infection
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.3%
5/79 • Number of events 5 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
6.2%
5/81 • Number of events 5 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.5%
2/79 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
4.9%
4/81 • Number of events 4 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
2/79 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
2.5%
2/81 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
2.5%
2/81 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Musculoskeletal and connective tissue disorders
Greater trochanteric pain syndrome
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
4.9%
4/81 • Number of events 4 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Eye disorders
Cataract
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
2.5%
2/81 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Eye disorders
Macular oedema
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Eye disorders
Retinal haemorrhage
|
2.5%
2/79 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Eye disorders
Conjunctival irritation
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Eye disorders
Conjunctivitis allergenic
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Eye disorders
Diabetic retinal oedema
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Eye disorders
Dry eye
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Eye disorders
Ocular hypertension
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Eye disorders
Posterior capsule opacification
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Eye disorders
Retinal scar
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Eye disorders
Retinal tear
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Eye disorders
Uveitis
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Eye disorders
Vision blurred
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
General disorders
Injection site pain
|
5.1%
4/79 • Number of events 4 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
General disorders
Peripheral swelling
|
2.5%
2/79 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
General disorders
Chest pain
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
General disorders
Fatigue
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
2.5%
2/81 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Infections and infestations
Oedema peripheral
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
General disorders
Feeling hot
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
General disorders
Injection site haematoma
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
General disorders
Injection site scar
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
General disorders
Injection site swelling
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
General disorders
Non-cardiac chest pain
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Gastrointestinal disorders
Constipation
|
3.8%
3/79 • Number of events 3 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
2/79 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
2/79 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Gastrointestinal disorders
Nausea
|
2.5%
2/79 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Gastrointestinal disorders
Abdominal hernia
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Gastrointestinal disorders
Ascites
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Gastrointestinal disorders
Diverticulum
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Gastrointestinal disorders
Ileus
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Gastrointestinal disorders
Umbilical hernia
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Injury, poisoning and procedural complications
Wound
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Injury, poisoning and procedural complications
Contusion
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Nervous system disorders
Hypoaesthesia
|
3.8%
3/79 • Number of events 3 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Nervous system disorders
Headache
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
2.5%
2/81 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
2.5%
2/81 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
2.5%
2/81 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Nervous system disorders
Cerebral small vessel ischaemic disease
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Nervous system disorders
Coordination abnormal
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Nervous system disorders
Dizziness
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Nervous system disorders
Electric shock sensation
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Nervous system disorders
Presyncope
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
3.7%
3/81 • Number of events 3 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
2.5%
2/81 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Metabolism and nutrition disorders
Hypophasphataemia
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Metabolism and nutrition disorders
Hypovolemia
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Cardiac disorders
Atrioventricular block first degree
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Cardiac disorders
Cardiac failure congestive
|
2.5%
2/79 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Cardiac disorders
Angina pectoris
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Cardiac disorders
Aortic valve calcification
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Cardiac disorders
Bundle branch block left
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Cardiac disorders
Cardiomegaly
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Cardiac disorders
Sinus tachycardia
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
2.5%
2/81 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
2.5%
2/79 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
4.9%
4/81 • Number of events 4 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Respiratory, thoracic and mediastinal disorders
Plueral effusion
|
2.5%
2/79 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery dilatation
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Psychiatric disorders
Stress
|
2.5%
2/79 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Psychiatric disorders
Anxiety
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Vascular disorders
Hypertension
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
2.5%
2/81 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Vascular disorders
Aortic arteriosclerosis
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Vascular disorders
Arteriosclerosis
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
2/79 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.5%
2/79 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
2.5%
2/81 • Number of events 2 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Investigations
Cardiac stress test abnormal
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Investigations
Lipase increased
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Renal and urinary disorders
Polyuria
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Reproductive system and breast disorders
Endometrial thickening
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Reproductive system and breast disorders
Pelvic cyst
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Reproductive system and breast disorders
Vaginal cyst
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Hepatobiliary disorders
Hepatomegaly
|
1.3%
1/79 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
0.00%
0/81 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/79 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
1.2%
1/81 • Number of events 1 • Baseline (Day 0) to Day 180
Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Term - Safety Populations
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study is part of a multi-center research study, and publication of the results of the Study conducted at the Site shall not be made before the first multi-center publication by Sponsor. If there is not a multi-center publication within eighteen (18) months after the Study has been completed or terminated at all Study sites, and all data has been received, Site shall have the right to publish its results from the Study, subject to the following notice requirements.
- Publication restrictions are in place
Restriction type: OTHER