Trial Outcomes & Findings for Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus (NCT NCT01194245)
NCT ID: NCT01194245
Last Updated: 2019-02-26
Results Overview
Glycosylated hemoglobin A1C (HBA1c) levels were measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). Least Squares (LS) means were calculated from mixed effects linear models with treatment (Lispro, Aspart), recombinant human hyaluronidase PH20 (rHuPH20; yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
135 participants
Primary outcome timeframe
Baseline, Week 12 and Week 24
Results posted on
2019-02-26
Participant Flow
The study included an open-label titration period of at least 4 weeks and up to 6 weeks prior to randomization at Week 0.
Participant milestones
| Measure |
All Enrolled Participants
Prior to randomization, all enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Lispro-PH20 First, Then Insulin Lispro
Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.
Lispro-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Insulin Lispro First, Then Lispro-PH20
Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.
Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Aspart-PH20 First, Then Insulin Lispro
Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.
Aspart-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Insulin Lispro First, Then Aspart-PH20
Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.
Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
|---|---|---|---|---|---|
|
Titration Period (4 to 6 Weeks)
STARTED
|
135
|
0
|
0
|
0
|
0
|
|
Titration Period (4 to 6 Weeks)
COMPLETED
|
117
|
0
|
0
|
0
|
0
|
|
Titration Period (4 to 6 Weeks)
NOT COMPLETED
|
18
|
0
|
0
|
0
|
0
|
|
Treatment Period 1 (Weeks 0 to 12)
STARTED
|
0
|
29
|
28
|
30
|
30
|
|
Treatment Period 1 (Weeks 0 to 12)
Received at Least 1 Dose of Study Drug
|
0
|
29
|
28
|
30
|
30
|
|
Treatment Period 1 (Weeks 0 to 12)
COMPLETED
|
0
|
29
|
27
|
29
|
28
|
|
Treatment Period 1 (Weeks 0 to 12)
NOT COMPLETED
|
0
|
0
|
1
|
1
|
2
|
|
Treatment Period 2 (Weeks 12 to 24)
STARTED
|
0
|
29
|
27
|
29
|
28
|
|
Treatment Period 2 (Weeks 12 to 24)
COMPLETED
|
0
|
29
|
27
|
29
|
28
|
|
Treatment Period 2 (Weeks 12 to 24)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
All Enrolled Participants
Prior to randomization, all enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Lispro-PH20 First, Then Insulin Lispro
Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.
Lispro-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Insulin Lispro First, Then Lispro-PH20
Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.
Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Aspart-PH20 First, Then Insulin Lispro
Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.
Aspart-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Insulin Lispro First, Then Aspart-PH20
Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.
Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
|---|---|---|---|---|---|
|
Titration Period (4 to 6 Weeks)
Withdrawal by Subject
|
5
|
0
|
0
|
0
|
0
|
|
Titration Period (4 to 6 Weeks)
Physician Decision
|
3
|
0
|
0
|
0
|
0
|
|
Titration Period (4 to 6 Weeks)
Titration Failure
|
3
|
0
|
0
|
0
|
0
|
|
Titration Period (4 to 6 Weeks)
Did Not Meet Randomization Criteria
|
7
|
0
|
0
|
0
|
0
|
|
Treatment Period 1 (Weeks 0 to 12)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 1 (Weeks 0 to 12)
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
1
|
Baseline Characteristics
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Non-randomized Participants
n=18 Participants
Participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually. Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
Participants did not complete the titration period or did not meet one or more randomization criteria and, therefore, were not randomized.
|
Lispro-PH20 First, Then Insulin Lispro
n=29 Participants
Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.
Lispro-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Insulin Lispro First, Then Lispro-PH20
n=28 Participants
Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.
Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Aspart-PH20 First, Then Insulin Lispro
n=30 Participants
Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.
Aspart-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Insulin Lispro First, Then Aspart-PH20
n=30 Participants
Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.
Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.8 years
STANDARD_DEVIATION 11.71 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 14.56 • n=7 Participants
|
45.7 years
STANDARD_DEVIATION 14.94 • n=5 Participants
|
42.8 years
STANDARD_DEVIATION 14.13 • n=4 Participants
|
42.5 years
STANDARD_DEVIATION 14.70 • n=21 Participants
|
42.6 years
STANDARD_DEVIATION 14.41 • n=10 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
61 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
74 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
129 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
125 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
29 participants
n=7 Participants
|
28 participants
n=5 Participants
|
30 participants
n=4 Participants
|
30 participants
n=21 Participants
|
135 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12 and Week 24Population: Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable hemoglobin A1C data.
Glycosylated hemoglobin A1C (HBA1c) levels were measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). Least Squares (LS) means were calculated from mixed effects linear models with treatment (Lispro, Aspart), recombinant human hyaluronidase PH20 (rHuPH20; yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect.
Outcome measures
| Measure |
Analog-PH20
n=111 Participants
100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
|
Insulin Lispro
n=110 Participants
100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment Period
|
-0.14 percentage of hemoglobin A1C
Standard Deviation 0.415
|
-0.19 percentage of hemoglobin A1C
Standard Deviation 0.440
|
SECONDARY outcome
Timeframe: Week 10 and Week 22Population: Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable insulin dose data.
Prandial insulin doses were recorded during 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). The mean daily insulin dose over the 3 days during each treatment period is presented. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).
Outcome measures
| Measure |
Analog-PH20
n=102 Participants
100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
|
Insulin Lispro
n=105 Participants
100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
|
|---|---|---|
|
Mean Daily Insulin Dose
|
54.28 units (U)
Standard Deviation 27.071
|
56.05 units (U)
Standard Deviation 27.243
|
SECONDARY outcome
Timeframe: Baseline through Week 24, excluding 10-point glucose monitoring daysPopulation: Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable postprandial glucose data.
Participants were instructed to monitor their blood glucose levels a minimum of 4 times per day on all non-10-point glucose monitoring days. The number of participants meeting 90-minute postprandial plasma glucose (PPG) targets of \<140 and \<180 milligrams per deciliter (mg/dL) for at least 2/3 of values during non-10-point glucose monitoring days was recorded. The percentage was calculated by dividing the number of participants with values meeting the specified target at least 2/3 of the time by the total number of participants analyzed, multiplied by 100. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).
Outcome measures
| Measure |
Analog-PH20
n=113 Participants
100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
|
Insulin Lispro
n=113 Participants
100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
|
|---|---|---|
|
Percentage of Participants Meeting Glucose Targets
PPG <140 mg/dL for all meals
|
15.0 percentage of participants
|
8.8 percentage of participants
|
|
Percentage of Participants Meeting Glucose Targets
PPG <140 mg/dL for breakfast
|
21.4 percentage of participants
|
10.6 percentage of participants
|
|
Percentage of Participants Meeting Glucose Targets
PPG <180 mg/dL for all meals
|
69.9 percentage of participants
|
59.3 percentage of participants
|
|
Percentage of Participants Meeting Glucose Targets
PPG <180 mg/dL for breakfast
|
70.5 percentage of participants
|
54.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12 and Week 24Population: Participants who completed both Treatment Period 1 and Treatment Period 2.
Overall rates of hypoglycemia (blood glucose ≤70 milligrams per deciliter \[mg/dL\] and \<56 mg/dL) were calculated based on 4 weeks of observation for each treatment period. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Analog-PH20
n=113 Participants
100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
|
Insulin Lispro
n=113 Participants
100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
|
|---|---|---|
|
Rates of Hypoglycemia at the End of Each Treatment Period
≤70 mg/dL
|
18.96 events per participant per month
|
19.91 events per participant per month
|
|
Rates of Hypoglycemia at the End of Each Treatment Period
<56 mg/dL
|
7.50 events per participant per month
|
8.05 events per participant per month
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 24Population: Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable body weight data.
Body weight was measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).
Outcome measures
| Measure |
Analog-PH20
n=113 Participants
100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
|
Insulin Lispro
n=113 Participants
100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
|
|---|---|---|
|
Change From Baseline in Body Weight at the End of Each Treatment Period
|
-0.25 pounds (lbs)
Standard Deviation 5.702
|
0.10 pounds (lbs)
Standard Deviation 4.601
|
SECONDARY outcome
Timeframe: Week 10 and Week 22Population: Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable postprandial glucose (PPG) excursion data.
Participants performed 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). Mean daily postprandial plasma glucose (PPG) excursions (referring to the change in blood glucose levels from before to after a meal) during 10-point glucose monitoring for breakfast, lunch, and dinner are presented. Data were collected 1 and 2 hours (hr) after each meal for 3 days and the means of each excursion are presented.
Outcome measures
| Measure |
Analog-PH20
n=102 Participants
100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
|
Insulin Lispro
n=106 Participants
100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
|
|---|---|---|
|
Mean Daily Postprandial Glucose (PPG) Excursions
2-hr dinner excursion
|
-5.13 milligrams per deciliter (mg/dL)
Standard Deviation 46.956
|
-5.16 milligrams per deciliter (mg/dL)
Standard Deviation 54.309
|
|
Mean Daily Postprandial Glucose (PPG) Excursions
1-hr breakfast excursion
|
18.85 milligrams per deciliter (mg/dL)
Standard Deviation 48.348
|
27.46 milligrams per deciliter (mg/dL)
Standard Deviation 43.938
|
|
Mean Daily Postprandial Glucose (PPG) Excursions
2-hr breakfast excursion
|
-5.63 milligrams per deciliter (mg/dL)
Standard Deviation 52.657
|
7.08 milligrams per deciliter (mg/dL)
Standard Deviation 56.997
|
|
Mean Daily Postprandial Glucose (PPG) Excursions
1-hr lunch excursion
|
16.26 milligrams per deciliter (mg/dL)
Standard Deviation 46.524
|
26.25 milligrams per deciliter (mg/dL)
Standard Deviation 39.070
|
|
Mean Daily Postprandial Glucose (PPG) Excursions
2-hr lunch excursion
|
10.68 milligrams per deciliter (mg/dL)
Standard Deviation 53.787
|
20.77 milligrams per deciliter (mg/dL)
Standard Deviation 47.005
|
|
Mean Daily Postprandial Glucose (PPG) Excursions
1-hr dinner excursion
|
-0.31 milligrams per deciliter (mg/dL)
Standard Deviation 41.368
|
4.47 milligrams per deciliter (mg/dL)
Standard Deviation 52.986
|
Adverse Events
Titration Period (All Enrolled Participants)
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Lispro-PH20 Treatment Period
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Insulin Lispro (Lispro-PH20 Cohort) Treatment Period
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Aspart-PH20 Treatment Period
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Insulin Lispro (Aspart-PH20 Cohort) Treatment Period
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Titration Period (All Enrolled Participants)
n=135 participants at risk
Prior to randomization, all enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Lispro-PH20 Treatment Period
n=56 participants at risk
100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Insulin Lispro (Lispro-PH20 Cohort) Treatment Period
n=57 participants at risk
Participants were randomized to the Lispro-PH20 cohort.
100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Aspart-PH20 Treatment Period
n=58 participants at risk
100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Insulin Lispro (Aspart-PH20 Cohort) Treatment Period
n=59 participants at risk
Participants were randomized to the Aspart-PH20 cohort.
100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Cardiac disorders
Pericarditis
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
Other adverse events
| Measure |
Titration Period (All Enrolled Participants)
n=135 participants at risk
Prior to randomization, all enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Lispro-PH20 Treatment Period
n=56 participants at risk
100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Insulin Lispro (Lispro-PH20 Cohort) Treatment Period
n=57 participants at risk
Participants were randomized to the Lispro-PH20 cohort.
100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Aspart-PH20 Treatment Period
n=58 participants at risk
100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Insulin Lispro (Aspart-PH20 Cohort) Treatment Period
n=59 participants at risk
Participants were randomized to the Aspart-PH20 cohort.
100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually
Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Psychiatric disorders
Anxiety
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
General disorders
Asthenia
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Eye disorders
Astigmatism
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
2/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
3.6%
2/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Cardiac disorders
Bradycardia
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
3.6%
2/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
General disorders
Chest discomfort
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
General disorders
Chills
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
5.2%
3/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Cystitis
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Psychiatric disorders
Depression
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
3/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
3.6%
2/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/61
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/26
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
3.8%
1/26
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/28
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/29
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Gastrointestinal disorders
Dysphagia
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Ear infection
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
General disorders
Fatigue
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Gastrointestinal disorders
Food poisoning
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Gastroenteritis viral
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
3.5%
2/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
3.4%
2/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
5.1%
3/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
3.4%
2/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Endocrine disorders
Goitre
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/61
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/26
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/26
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/28
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
3.4%
1/29
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Nervous system disorders
Headache
|
1.5%
2/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
6.9%
4/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Herpes zoster
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
3.6%
2/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Vascular disorders
Hypertension
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Influenza
|
2.2%
3/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
3.6%
2/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
3.5%
2/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
General disorders
Influenza like illness
|
1.5%
2/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
3.6%
2/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
3.5%
2/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
General disorders
Injection site erythema
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
General disorders
Injection site haematoma
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Injection site infection
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
General disorders
Injection site pain
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
General disorders
Injection site pruritus
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
General disorders
Injection site rash
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
General disorders
Injection site urticaria
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Localised infection
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
8/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
14.3%
8/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
14.0%
8/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
13.8%
8/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
10.2%
6/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
2/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
5.1%
3/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
General disorders
Non-cardiac chest pain
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
General disorders
Oedema peripheral
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Gastrointestinal disorders
Oral pain
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.5%
2/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
General disorders
Pain
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
2/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Cardiac disorders
Pericarditis
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
General disorders
Pyrexia
|
1.5%
2/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
5.3%
3/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
3.5%
2/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Sinusitis
|
3.7%
5/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
3.6%
2/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
5.3%
3/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
8.6%
5/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
3.4%
2/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Psychiatric disorders
Stress
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Social circumstances
Stress at work
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Tinea pedis
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Gastrointestinal disorders
Toothache
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Musculoskeletal and connective tissue disorders
Trochanteric syndrome
|
0.74%
1/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
8/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
12.5%
7/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
5.3%
3/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
3.4%
2/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
5.1%
3/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
3.4%
2/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Viral infection
|
0.00%
0/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.5%
2/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
2/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.8%
1/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
1.7%
1/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
|
Investigations
Weight increased
|
2.2%
3/135
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/56
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/57
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/58
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
0.00%
0/59
Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
|
Additional Information
Vice President, Endocrinology Clinical Development
Halozyme Therapeutics, Inc.
Phone: 858-794-8889
Results disclosure agreements
- Principal investigator is a sponsor employee All information obtained as a result of this study or during the conduct of this study will be regarded as confidential. The Investigator agrees to use the information for the purpose of carrying out this study and for no other purpose, unless written permission from the sponsor (Halozyme) is obtained.
- Publication restrictions are in place
Restriction type: OTHER