Trial Outcomes & Findings for Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients (NCT NCT02666430)
NCT ID: NCT02666430
Last Updated: 2022-03-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
127 participants
Primary outcome timeframe
Baseline to 36 weeks
Results posted on
2022-03-03
Participant Flow
Participant milestones
| Measure |
Mylan's Insulin Glargine Sequence
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Mylan's insulin glargine
|
Lantus® Sequence
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Lantus®
|
|---|---|---|
|
Baseline
STARTED
|
64
|
63
|
|
Baseline
COMPLETED
|
64
|
63
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
Period 1
STARTED
|
64
|
63
|
|
Period 1
COMPLETED
|
63
|
62
|
|
Period 1
NOT COMPLETED
|
1
|
1
|
|
Period 2
STARTED
|
63
|
62
|
|
Period 2
COMPLETED
|
62
|
58
|
|
Period 2
NOT COMPLETED
|
1
|
4
|
|
Period 3
STARTED
|
62
|
58
|
|
Period 3
COMPLETED
|
61
|
58
|
|
Period 3
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Mylan's Insulin Glargine Sequence
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Mylan's insulin glargine
|
Lantus® Sequence
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Lantus®
|
|---|---|---|
|
Period 1
Lost to Follow-up
|
1
|
0
|
|
Period 1
Adverse Event
|
0
|
1
|
|
Period 2
Withdrawal by Subject
|
1
|
4
|
|
Period 3
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients
Baseline characteristics by cohort
| Measure |
Mylan's Insulin Glargine
n=64 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Mylan's insulin glargine
|
Lantus®
n=63 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Lantus®
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 11.43 • n=39 Participants
|
43.2 years
STANDARD_DEVIATION 12.69 • n=41 Participants
|
44.0 years
STANDARD_DEVIATION 12.05 • n=35 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=39 Participants
|
27 Participants
n=41 Participants
|
50 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=39 Participants
|
36 Participants
n=41 Participants
|
77 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=39 Participants
|
0 participants
n=41 Participants
|
2 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=39 Participants
|
2 participants
n=41 Participants
|
4 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=39 Participants
|
0 participants
n=41 Participants
|
1 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
59 participants
n=39 Participants
|
61 participants
n=41 Participants
|
120 participants
n=35 Participants
|
|
Region of Enrollment
Europe
|
30 participants
n=39 Participants
|
27 participants
n=41 Participants
|
57 participants
n=35 Participants
|
|
Region of Enrollment
North America
|
34 participants
n=39 Participants
|
36 participants
n=41 Participants
|
70 participants
n=35 Participants
|
|
Dosing Time
Morning
|
11 participants
n=39 Participants
|
12 participants
n=41 Participants
|
23 participants
n=35 Participants
|
|
Dosing Time
Evening
|
53 participants
n=39 Participants
|
51 participants
n=41 Participants
|
104 participants
n=35 Participants
|
|
Baseline HIV Status
Negative
|
64 participants
n=39 Participants
|
62 participants
n=41 Participants
|
126 participants
n=35 Participants
|
|
Baseline HIV Status
Positive
|
0 participants
n=39 Participants
|
1 participants
n=41 Participants
|
1 participants
n=35 Participants
|
|
Hepatitis B surface antigen (HBsAg)
Negative
|
64 participants
n=39 Participants
|
63 participants
n=41 Participants
|
127 participants
n=35 Participants
|
|
Hepatitis B surface antigen (HBsAg)
Positive
|
0 participants
n=39 Participants
|
0 participants
n=41 Participants
|
0 participants
n=35 Participants
|
|
Baseline hepatitis C antibody (HCVAb)
Low positive
|
0 participants
n=39 Participants
|
1 participants
n=41 Participants
|
1 participants
n=35 Participants
|
|
Baseline hepatitis C antibody (HCVAb)
Negative
|
64 participants
n=39 Participants
|
62 participants
n=41 Participants
|
126 participants
n=35 Participants
|
|
Weight
|
80.712 kilograms
STANDARD_DEVIATION 16.5393 • n=39 Participants
|
82.415 kilograms
STANDARD_DEVIATION 15.2942 • n=41 Participants
|
81.557 kilograms
STANDARD_DEVIATION 15.8936 • n=35 Participants
|
|
Height
|
173.299 centimeters
STANDARD_DEVIATION 9.9451 • n=39 Participants
|
174.092 centimeters
STANDARD_DEVIATION 8.5502 • n=41 Participants
|
173.692 centimeters
STANDARD_DEVIATION 9.2511 • n=35 Participants
|
|
Body mass index
|
26.744 kg/m2
STANDARD_DEVIATION 4.1795 • n=39 Participants
|
27.134 kg/m2
STANDARD_DEVIATION 4.4084 • n=41 Participants
|
26.937 kg/m2
STANDARD_DEVIATION 4.2820 • n=35 Participants
|
|
Duration of diabetes
|
21.369 years
STANDARD_DEVIATION 12.8879 • n=39 Participants
|
20.212 years
STANDARD_DEVIATION 8.9657 • n=41 Participants
|
20.801 years
STANDARD_DEVIATION 11.1013 • n=35 Participants
|
|
Baseline fasting plasma glucose
|
9.82 mmol/L
STANDARD_DEVIATION 3.455 • n=39 Participants
|
9.51 mmol/L
STANDARD_DEVIATION 4.099 • n=41 Participants
|
9.67 mmol/L
STANDARD_DEVIATION 3.779 • n=35 Participants
|
|
Baseline hemoglobin A1c (HbA1c)
|
7.64 %
STANDARD_DEVIATION 0.997 • n=39 Participants
|
7.87 %
STANDARD_DEVIATION 0.913 • n=41 Participants
|
7.75 %
STANDARD_DEVIATION 0.959 • n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline to 36 weeksOutcome measures
| Measure |
Mylan's Insulin Glargine
n=61 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Mylan's insulin glargine
|
Lantus®
n=57 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Lantus®
|
|---|---|---|
|
Change in Hemoglobin A1c (HbA1c) From Baseline
|
-0.05 percent
Standard Error 0.032
|
-0.06 percent
Standard Error 0.034
|
SECONDARY outcome
Timeframe: Baseline to 36 weeksOutcome measures
| Measure |
Mylan's Insulin Glargine
n=64 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Mylan's insulin glargine
|
Lantus®
n=63 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Lantus®
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose
|
-0.56 mmol/L
Standard Deviation 3.458
|
0.10 mmol/L
Standard Deviation 4.521
|
SECONDARY outcome
Timeframe: Baseline to 36 weeksOutcome measures
| Measure |
Mylan's Insulin Glargine
n=64 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Mylan's insulin glargine
|
Lantus®
n=63 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Lantus®
|
|---|---|---|
|
Overall Average of Self-monitoring Blood Glucose (SMBG) Change From Baseline
|
-0.144 mmol/L
Standard Deviation 1.2569
|
-0.426 mmol/L
Standard Deviation 1.1243
|
SECONDARY outcome
Timeframe: Baseline to 36 weeksOutcome measures
| Measure |
Mylan's Insulin Glargine
n=64 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Mylan's insulin glargine
|
Lantus®
n=63 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Lantus®
|
|---|---|---|
|
Change From Baseline Total Daily Insulin Dose
|
0.0016 Units per kilogram
Standard Deviation 0.09239
|
0.0023 Units per kilogram
Standard Deviation 0.07712
|
SECONDARY outcome
Timeframe: Baseline to 40 weeksOutcome measures
| Measure |
Mylan's Insulin Glargine
n=64 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Mylan's insulin glargine
|
Lantus®
n=63 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Lantus®
|
|---|---|---|
|
Local and Systemic Allergic Reactions
Local
|
1 participants
|
1 participants
|
|
Local and Systemic Allergic Reactions
Systemic
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to 36 weeksOutcome measures
| Measure |
Mylan's Insulin Glargine
n=64 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Mylan's insulin glargine
|
Lantus®
n=63 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Lantus®
|
|---|---|---|
|
Hypoglycemic Rate
|
0.627 episodes/30 days
Standard Deviation 2.7180
|
0.410 episodes/30 days
Standard Deviation 4.0911
|
SECONDARY outcome
Timeframe: Baseline to 36 weeksOutcome measures
| Measure |
Mylan's Insulin Glargine
n=64 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Mylan's insulin glargine
|
Lantus®
n=63 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Lantus®
|
|---|---|---|
|
Hypoglycemic Incidence
|
58 events
|
57 events
|
SECONDARY outcome
Timeframe: Baseline to 36 weeksOutcome measures
| Measure |
Mylan's Insulin Glargine
n=64 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Mylan's insulin glargine
|
Lantus®
n=63 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Lantus®
|
|---|---|---|
|
Change From Baseline in Total Insulin Antibodies - Mylan Insulin Glargine Assay
|
-2.098 percent binding
Standard Deviation 5.3826
|
-2.474 percent binding
Standard Deviation 5.2505
|
SECONDARY outcome
Timeframe: Baseline to 36 weeksOutcome measures
| Measure |
Mylan's Insulin Glargine
n=64 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Mylan's insulin glargine
|
Lantus®
n=63 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Lantus®
|
|---|---|---|
|
Change From Baseline in Total Insulin Antibodies - Lantus Assay
|
-1.288 percent binding
Standard Deviation 4.9617
|
-2.351 percent binding
Standard Deviation 5.374
|
SECONDARY outcome
Timeframe: Baseline to 36 weeksOutcome measures
| Measure |
Mylan's Insulin Glargine
n=64 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Mylan's insulin glargine
|
Lantus®
n=63 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Lantus®
|
|---|---|---|
|
Change From Baseline in Cross-Reactive Insulin Antibody - Mylan Insulin Glargine Assay
|
-2.051 percent binding
Standard Deviation 5.3697
|
-2.252 percent binding
Standard Deviation 5.1904
|
SECONDARY outcome
Timeframe: Baseline to 36 weeksOutcome measures
| Measure |
Mylan's Insulin Glargine
n=64 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Mylan's insulin glargine
|
Lantus®
n=63 Participants
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Lantus®
|
|---|---|---|
|
Change From Baseline in Cross-Reactive Insulin Antibody - Lantus Assay
|
-1.232 percent binding
Standard Deviation 4.8965
|
-2.192 percent binding
Standard Deviation 5.1741
|
Adverse Events
Mylan's Insulin Glargine Sequence
Serious events: 2 serious events
Other events: 41 other events
Deaths: 0 deaths
Lantus® Sequence
Serious events: 5 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mylan's Insulin Glargine Sequence
n=64 participants at risk
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Mylan's insulin glargine
|
Lantus® Sequence
n=63 participants at risk
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Lantus®
|
|---|---|---|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Eye disorders
Retinal detachment
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
Other adverse events
| Measure |
Mylan's Insulin Glargine Sequence
n=64 participants at risk
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Mylan's insulin glargine
|
Lantus® Sequence
n=63 participants at risk
Patients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Lantus®
|
|---|---|---|
|
Injury, poisoning and procedural complications
Muscle strain
|
3.1%
2/64 • Number of events 2 • 40 weeks
|
3.2%
2/63 • Number of events 2 • 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/64 • 40 weeks
|
3.2%
2/63 • Number of events 2 • 40 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
3.2%
2/63 • Number of events 2 • 40 weeks
|
|
Immune system disorders
Seasonal allergy
|
4.7%
3/64 • Number of events 4 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Eye disorders
Diabetic retinopathy
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
6.3%
4/63 • Number of events 4 • 40 weeks
|
|
General disorders
Fatigue
|
3.1%
2/64 • Number of events 2 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Psychiatric disorders
Stress
|
3.1%
2/64 • Number of events 2 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.1%
2/64 • Number of events 2 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
2/64 • Number of events 2 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.1%
2/64 • Number of events 2 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/64 • 40 weeks
|
3.2%
2/63 • Number of events 2 • 40 weeks
|
|
Infections and infestations
Bronchitis
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
3.2%
2/63 • Number of events 2 • 40 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
3.1%
2/64 • Number of events 2 • 40 weeks
|
3.2%
2/63 • Number of events 2 • 40 weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/64 • 40 weeks
|
4.8%
3/63 • Number of events 3 • 40 weeks
|
|
Infections and infestations
Influenza
|
4.7%
3/64 • Number of events 3 • 40 weeks
|
3.2%
2/63 • Number of events 2 • 40 weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
3/64 • Number of events 3 • 40 weeks
|
6.3%
4/63 • Number of events 8 • 40 weeks
|
|
Infections and infestations
Sinusitis
|
3.1%
2/64 • Number of events 3 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
10.9%
7/64 • Number of events 8 • 40 weeks
|
7.9%
5/63 • Number of events 7 • 40 weeks
|
|
Infections and infestations
Rhinitis
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Tinea pedis
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Cystitis
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Furuncle
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Otitis externa fungal
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Periodontis
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Pharyngotonsillitis
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Infections and infestations
Pulpitis dental
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Infections and infestations
Tracheitis
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Respiratory tract infection
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Infections and infestations
Tooth abscess
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Infections and infestations
Tooth infection
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Infections and infestations
Viral infection
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Injury, poisoning and procedural complications
Wound
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
1.6%
1/64 • Number of events 2 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Gastrointestinal disorders
Constipation
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Gastrointestinal disorders
Dental caries
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/64 • Number of events 1 • 40 weeks
|
0.00%
0/63 • 40 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/64 • 40 weeks
|
1.6%
1/63 • Number of events 1 • 40 weeks
|
Additional Information
Keri L Vaughan
Director Global Clinical Operations, General Medicine
Phone: +1 267.980.5015
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place