Trial Outcomes & Findings for Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus (NCT NCT01194258)
NCT ID: NCT01194258
Last Updated: 2014-08-20
Results Overview
Change in glycosylated hemoglobin A1C (HbA1C) from baseline (Week 0) to end of treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-recombinant human hyaluronidase PH20 (PH20) + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). Least squares (LS) means were calculated from linear contrasts of mixed effects linear models with treatment (Lispro, Aspart), PH20 (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
132 participants
Primary outcome timeframe
Baseline, Week 12 and Week 24
Results posted on
2014-08-20
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 to 6 weeks in which they received 100 U/mL insulin glulisine, injected 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, Then Lispro-PH20
Participants received a subcutaneous (SC) injection of 100 units per milliliter (U/mL) insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 of the study.
Then, participants received a SC injection of 100 U insulin lispro and 5 micrograms (µg) recombinant human hyaluronidase PH20 (rHuPH20) (combined: Lispro-PH20) pre-meals for 12 weeks during Treatment Period 2 of the study.
|
Lispro-PH20, Then Insulin Lispro
Participants received a SC injection of 100 U/mL insulin lispro and 5 µg rHuPH20 (Lispro-PH20) pre-meals for 12 weeks during Treatment Period 1 of the study.
Then, participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 2 of the study.
|
Insulin Lispro, Then Aspart-PH20
Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 of the study.
Then, participants received a SC injection of 100 U/mL insulin aspart and 5 µg rHuPH20 (combined: Aspart-PH20) pre-meals for 12 weeks during Treatment Period 2 of the study.
|
Aspart-PH20, Then Insulin Lispro
Participants received SC injection of 100 U/mL insulin aspart and 5 µg rHuPH20 (Aspart-PH20) pre-meals for 12 weeks during Treatment Period 1 of the study.
Then, participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 2 of the study.
|
|---|---|---|---|---|---|
|
Titration Period
STARTED
|
132
|
0
|
0
|
0
|
0
|
|
Titration Period
COMPLETED
|
121
|
0
|
0
|
0
|
0
|
|
Titration Period
NOT COMPLETED
|
11
|
0
|
0
|
0
|
0
|
|
Period 1 (12 Weeks)
STARTED
|
0
|
29
|
30
|
29
|
33
|
|
Period 1 (12 Weeks)
Received at Least 1 Dose of Study Drug
|
0
|
29
|
30
|
29
|
33
|
|
Period 1 (12 Weeks)
COMPLETED
|
0
|
29
|
30
|
29
|
32
|
|
Period 1 (12 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
|
Period 2 (12 Weeks)
STARTED
|
0
|
29
|
30
|
29
|
32
|
|
Period 2 (12 Weeks)
COMPLETED
|
0
|
27
|
29
|
29
|
30
|
|
Period 2 (12 Weeks)
NOT COMPLETED
|
0
|
2
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
All Enrolled Participants
Prior to randomization, all enrolled participants underwent a titration period of 4 to 6 weeks in which they received 100 U/mL insulin glulisine, injected 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, Then Lispro-PH20
Participants received a subcutaneous (SC) injection of 100 units per milliliter (U/mL) insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 of the study.
Then, participants received a SC injection of 100 U insulin lispro and 5 micrograms (µg) recombinant human hyaluronidase PH20 (rHuPH20) (combined: Lispro-PH20) pre-meals for 12 weeks during Treatment Period 2 of the study.
|
Lispro-PH20, Then Insulin Lispro
Participants received a SC injection of 100 U/mL insulin lispro and 5 µg rHuPH20 (Lispro-PH20) pre-meals for 12 weeks during Treatment Period 1 of the study.
Then, participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 2 of the study.
|
Insulin Lispro, Then Aspart-PH20
Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 of the study.
Then, participants received a SC injection of 100 U/mL insulin aspart and 5 µg rHuPH20 (combined: Aspart-PH20) pre-meals for 12 weeks during Treatment Period 2 of the study.
|
Aspart-PH20, Then Insulin Lispro
Participants received SC injection of 100 U/mL insulin aspart and 5 µg rHuPH20 (Aspart-PH20) pre-meals for 12 weeks during Treatment Period 1 of the study.
Then, participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 2 of the study.
|
|---|---|---|---|---|---|
|
Titration Period
Withdrawal by Subject
|
6
|
0
|
0
|
0
|
0
|
|
Titration Period
Lost to Follow-up
|
2
|
0
|
0
|
0
|
0
|
|
Titration Period
Titration failure
|
3
|
0
|
0
|
0
|
0
|
|
Period 1 (12 Weeks)
Death
|
0
|
0
|
0
|
0
|
1
|
|
Period 2 (12 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
2
|
|
Period 2 (12 Weeks)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
|
Period 2 (12 Weeks)
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
All Study Participants
n=132 Participants
All participants in the study, including those who were enrolled but were not randomized.
|
|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 9.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
115 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
113 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
132 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12 and Week 24Population: All participants who completed both Treatment Period 1 and Treatment Period 2 with evaluable HbA1C data.
Change in glycosylated hemoglobin A1C (HbA1C) from baseline (Week 0) to end of treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-recombinant human hyaluronidase PH20 (PH20) + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). Least squares (LS) means were calculated from linear contrasts of mixed effects linear models with treatment (Lispro, Aspart), PH20 (yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect.
Outcome measures
| Measure |
Analog-PH20
n=115 Participants
100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
|
Insulin Lispro
n=115 Participants
100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin A1C (HbA1C) at the End of Each Treatment Period
|
-0.48 percentage of HbA1C
Standard Deviation 0.590
|
-0.46 percentage of HbA1C
Standard Deviation 0.571
|
SECONDARY outcome
Timeframe: Week 10 and Week 22Population: All participants who completed both Treatment Period 1 and Treatment Period 2 with evaluable insulin dosing data.
Mean daily insulin dose as recorded during 10-point glucose monitoring is reported. Blood glucose values were obtained during 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) at the following timepoints: immediately prior to breakfast (fasting), 1 hour (hr) after breakfast, 2 hr after breakfast, immediately prior to lunch, 1 hr after lunch, 2 hr after lunch, immediately prior to dinner, 1 hr after dinner, 2 hr after dinner, and at 03:00. A minimum of 7 determinations were required for each day during the 3 days of 10-point glucose profiles. Prandial insulin doses were also recorded during the 10-point glucose monitoring and the mean daily insulin dose over the 3 days was calculated. Data are 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=104 Participants
100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
|
Insulin Lispro
n=107 Participants
100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
|
|---|---|---|
|
Mean Daily Insulin Dose as Recorded During 10-Point Glucose Monitoring
|
122.99 units of Insulin
Standard Deviation 67.150
|
127.47 units of Insulin
Standard Deviation 69.483
|
SECONDARY outcome
Timeframe: Baseline through Week 24, excluding 10-point glucose monitoring daysPopulation: Participants in Treatment Period 1 or Treatment Period 2 who received at least 1 dose of study drug and had evaluable postprandial blood 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 was recorded during non-10-point glucose monitoring was recorded. The number of participants was recorded, and the percentage of participants meeting glucose targets was calculated by 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=115 Participants
100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
|
Insulin Lispro
n=115 Participants
100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
|
|---|---|---|
|
Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time
Overall 90-minute PPG <140 mg/dL
|
13.9 Percentage of participants
|
14.8 Percentage of participants
|
|
Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time
PPG <140 mg/dL for breakfast
|
24.3 Percentage of participants
|
17.4 Percentage of participants
|
|
Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time
PPG <140 mg/dL for lunch
|
28.7 Percentage of participants
|
26.1 Percentage of participants
|
|
Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time
PPG <140 mg/dL for dinner
|
13.0 Percentage of participants
|
15.7 Percentage of participants
|
|
Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time
Overall 90 minute PPG <180 mg/dL
|
71.3 Percentage of participants
|
74.8 Percentage of participants
|
|
Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time
PPG <180 mg/dL for breakfast
|
70.4 Percentage of participants
|
65.2 Percentage of participants
|
|
Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time
PPG <180 mg/dL for lunch
|
83.5 Percentage of participants
|
80.0 Percentage of participants
|
|
Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time
PPG <180 mg/dL for dinner
|
67.0 Percentage of participants
|
70.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12 and Week 24Population: All participants who completed both Treatment Period 1 and Treatment Period 2.
The rate of hypoglycemia, defined as blood glucose levels ≤70 mg/dL and \<56 mg/dL, was calculated based on 4 weeks of observation prior to the end of treatment period (that is, 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 groups). 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=115 Participants
100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
|
Insulin Lispro
n=115 Participants
100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
|
|---|---|---|
|
Rates of Hypoglycemia at the End of Each Treatment Period
Blood glucose <70 mg/dL (n=111, n=113)
|
7.92 Events per participant per month
|
7.66 Events per participant per month
|
|
Rates of Hypoglycemia at the End of Each Treatment Period
Blood glucose <56 mg/dL (n=91, n=86)
|
1.99 Events per participant per month
|
1.78 Events per participant per month
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 24Population: All participants who completed both Period 1 and Period 2 with evaluable body weight data.
Change from baseline in body weight at the end of each treatment period (Week 12 and Week 24) is presented. Data are 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=115 Participants
100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
|
Insulin Lispro
n=115 Participants
100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
|
|---|---|---|
|
Change From Baseline in Body Weight at the End of Each Treatment Period
|
3.35 pounds
Standard Deviation 5.466
|
3.44 pounds
Standard Deviation 5.852
|
SECONDARY outcome
Timeframe: Week 10 and Week 22Population: All participants who completed both Period 1 and Period 2 with evaluable 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 PPG excursions during 10-point glucose monitoring for breakfast, lunch, and dinner from Treatment Period 1 or Treatment Period 2 are presented. PPG refers to the change in glucose concentration before to after a meal. Data were collected 1 and 2 hours (hr) after each meal. Data are 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=105 Participants
100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
|
Insulin Lispro
n=107 Participants
100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
|
|---|---|---|
|
Mean Daily PPG Excursions
1 hr after breakfast excursion (n=105, n=107)
|
33.67 mg/dL
Standard Deviation 34.480
|
40.38 mg/dL
Standard Deviation 30.213
|
|
Mean Daily PPG Excursions
2 hr after breakfast excursion (n=105, n=107)
|
16.64 mg/dL
Standard Deviation 40.463
|
22.94 mg/dL
Standard Deviation 33.514
|
|
Mean Daily PPG Excursions
1 hr after lunch excursion (n=105, n=106)
|
18.47 mg/dL
Standard Deviation 35.419
|
27.28 mg/dL
Standard Deviation 30.075
|
|
Mean Daily PPG Excursions
2 hr after lunch excursion (n=104, n=106)
|
20.76 mg/dL
Standard Deviation 38.939
|
25.27 mg/dL
Standard Deviation 34.288
|
|
Mean Daily PPG Excursions
1 hr after dinner excursion (n=104, n=107)
|
21.24 mg/dL
Standard Deviation 32.807
|
18.09 mg/dL
Standard Deviation 28.869
|
|
Mean Daily PPG Excursions
2 hr after dinner excursion (n=104, n=107)
|
12.72 mg/dL
Standard Deviation 35.917
|
15.75 mg/dL
Standard Deviation 36.104
|
Adverse Events
Titration Period
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Insulin Lispro (Lispro-PH20 Cohort)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Lispro-PH20
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Insulin Lispro (Aspart-PH20 Cohort)
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Aspart-PH20
Serious events: 4 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Titration Period
n=132 participants at risk
Prior to randomization, all enrolled participants underwent a titration period of 4 to 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.
|
Insulin Lispro (Lispro-PH20 Cohort)
n=59 participants at risk
Participants randomized to the Lispro-PH20 cohort.
Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Lispro-PH20
n=59 participants at risk
Participants received a SC injection of 100 U/mL insulin lispro with 5 micrograms (μg) rHuPH20 pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Insulin Lispro (Aspart-PH20 Cohort)
n=60 participants at risk
Participants randomized to the Aspart-PH20 cohort.
Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Aspart-PH20
n=62 participants at risk
Participants received a SC injection of 100 U/mL insulin aspart and 5 μg rHuPH20 pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
3.2%
2/62 • Number of events 2
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
3.2%
2/62 • Number of events 2
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 2
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Gastrointestinal disorders
Dyspepsia
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Immune system disorders
Anaphylactic reaction
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
Other adverse events
| Measure |
Titration Period
n=132 participants at risk
Prior to randomization, all enrolled participants underwent a titration period of 4 to 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.
|
Insulin Lispro (Lispro-PH20 Cohort)
n=59 participants at risk
Participants randomized to the Lispro-PH20 cohort.
Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Lispro-PH20
n=59 participants at risk
Participants received a SC injection of 100 U/mL insulin lispro with 5 micrograms (μg) rHuPH20 pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Insulin Lispro (Aspart-PH20 Cohort)
n=60 participants at risk
Participants randomized to the Aspart-PH20 cohort.
Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
Aspart-PH20
n=62 participants at risk
Participants received a SC injection of 100 U/mL insulin aspart and 5 μg rHuPH20 pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.
Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
|
|---|---|---|---|---|---|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
0.00%
0/62
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
0.00%
0/62
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Cardiac disorders
Palpitations
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Eye disorders
Retinopathy proliferative
|
0.00%
0/132
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Eye disorders
Vision blurred
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
0.00%
0/62
|
|
Eye disorders
Chalazion
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
1.6%
1/62 • Number of events 1
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
1.6%
1/62 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
3/132 • Number of events 3
|
0.00%
0/59
|
8.5%
5/59 • Number of events 5
|
3.3%
2/60 • Number of events 2
|
3.2%
2/62 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.76%
1/132 • Number of events 2
|
1.7%
1/59 • Number of events 1
|
5.1%
3/59 • Number of events 3
|
5.0%
3/60 • Number of events 4
|
3.2%
2/62 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/132
|
0.00%
0/59
|
3.4%
2/59 • Number of events 2
|
3.3%
2/60 • Number of events 2
|
1.6%
1/62 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
1.6%
1/62 • Number of events 1
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
1.6%
1/62 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
0.00%
0/62
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
0.00%
0/62
|
|
General disorders
Oedema peripheral
|
0.76%
1/132 • Number of events 1
|
1.7%
1/59 • Number of events 2
|
3.4%
2/59 • Number of events 2
|
1.7%
1/60 • Number of events 1
|
1.6%
1/62 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.00%
0/132
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
General disorders
Facial pain
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
General disorders
Injection site haematoma
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
3.4%
2/59 • Number of events 2
|
0.00%
0/60
|
0.00%
0/62
|
|
General disorders
Injection site inflammation
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
0.00%
0/62
|
|
General disorders
Pain
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
General disorders
Pyrexia
|
0.00%
0/132
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
2/132 • Number of events 2
|
3.4%
2/59 • Number of events 2
|
5.1%
3/59 • Number of events 4
|
11.7%
7/60 • Number of events 7
|
6.5%
4/62 • Number of events 4
|
|
Infections and infestations
Influenza
|
1.5%
2/132 • Number of events 2
|
3.4%
2/59 • Number of events 2
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
4.5%
6/132 • Number of events 6
|
6.8%
4/59 • Number of events 4
|
11.9%
7/59 • Number of events 9
|
11.7%
7/60 • Number of events 9
|
4.8%
3/62 • Number of events 3
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
5.0%
3/60 • Number of events 3
|
3.2%
2/62 • Number of events 2
|
|
Infections and infestations
Gastroenteritis viral
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Infections and infestations
Sinusitis
|
2.3%
3/132 • Number of events 3
|
1.7%
1/59 • Number of events 1
|
3.4%
2/59 • Number of events 2
|
3.3%
2/60 • Number of events 2
|
3.2%
2/62 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
0.76%
1/132 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
1.6%
1/62 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
1.7%
1/60 • Number of events 1
|
1.6%
1/62 • Number of events 1
|
|
Infections and infestations
Ear infection
|
0.00%
0/132
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
0.00%
0/62
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/132
|
0.00%
0/59
|
3.4%
2/59 • Number of events 3
|
0.00%
0/60
|
3.2%
2/62 • Number of events 2
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/132
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/132
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/132
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/132
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/132
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Injury, poisoning and procedural complications
Contusion
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
3.2%
2/62 • Number of events 3
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Investigations
Weight increased
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
3.2%
2/62 • Number of events 2
|
|
Investigations
Cardiac murmur
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
0.00%
0/62
|
|
Metabolism and nutrition disorders
Central obesity
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
2/132 • Number of events 2
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
3.3%
2/60 • Number of events 2
|
0.00%
0/62
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/132
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.76%
1/132 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
5.0%
3/60 • Number of events 3
|
3.2%
2/62 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
0.00%
0/62
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
0.00%
0/62
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
6.5%
4/62 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
3.2%
2/62 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/53
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.76%
1/132 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
3.4%
2/59 • Number of events 2
|
0.00%
0/60
|
0.00%
0/62
|
|
Nervous system disorders
Headache
|
0.76%
1/132 • Number of events 1
|
3.4%
2/59 • Number of events 2
|
0.00%
0/59
|
3.3%
2/60 • Number of events 2
|
6.5%
4/62 • Number of events 5
|
|
Nervous system disorders
Cluster headache
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
0.00%
0/62
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/132
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
0.00%
0/62
|
|
Nervous system disorders
Dizziness
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
1.6%
1/62 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
1.6%
1/62 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/132
|
1.7%
1/59 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/132
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Psychiatric disorders
Delirium
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/132
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/79
|
2.6%
1/38 • Number of events 1
|
0.00%
0/38
|
0.00%
0/34
|
0.00%
0/34
|
|
Reproductive system and breast disorders
Prostatitis
|
1.3%
1/79 • Number of events 1
|
0.00%
0/38
|
0.00%
0/38
|
2.9%
1/34 • Number of events 1
|
0.00%
0/34
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/79
|
0.00%
0/38
|
0.00%
0/38
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.00%
0/79
|
0.00%
0/38
|
0.00%
0/38
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.76%
1/132 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
1.6%
1/62 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.5%
2/132 • Number of events 2
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.76%
1/132 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
0.00%
0/62
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
0.00%
0/62
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
0.00%
0/62
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
1.6%
1/62 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
3.3%
2/60 • Number of events 3
|
0.00%
0/62
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/132
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/132
|
0.00%
0/59
|
3.4%
2/59 • Number of events 2
|
0.00%
0/60
|
0.00%
0/62
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/132
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Skin and subcutaneous tissue disorders
Acanthosis nigricans
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/132
|
0.00%
0/59
|
0.00%
0/59
|
1.7%
1/60 • Number of events 1
|
0.00%
0/62
|
|
Vascular disorders
Hypertension
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
1.6%
1/62 • Number of events 1
|
|
Vascular disorders
Flushing
|
0.00%
0/132
|
0.00%
0/59
|
1.7%
1/59 • Number of events 1
|
0.00%
0/60
|
0.00%
0/62
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/132
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Immune system disorders
Seasonal allergy
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Psychiatric disorders
Depression
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Blood and lymphatic system disorders
Anaemia
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
General disorders
Fatigue
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Infections and infestations
Otitis externa
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Infections and infestations
Eye infection
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Infections and infestations
Parotitis
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.5%
2/132 • Number of events 2
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Metabolism and nutrition disorders
Gout
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.76%
1/132 • Number of events 1
|
0.00%
0/59
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/132
|
1.7%
1/59 • Number of events 1
|
0.00%
0/59
|
0.00%
0/60
|
0.00%
0/62
|
Additional Information
Vice President, Endocrinology Clinical Development
Halozyme Therapeutics
Phone: 858-794-8889
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER