Trial Outcomes & Findings for A Study of LY2439821 in Rheumatoid Arthritis (NCT NCT01236118)
NCT ID: NCT01236118
Last Updated: 2016-05-26
Results Overview
Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Baseline through study completion (up to Week 56)
Results posted on
2016-05-26
Participant Flow
Eligible participants must have completed Study I1F-JE-RHAL (NCT01253265) to meet the enrollment criteria of this study.
Participant milestones
| Measure |
30 mg LY2439821
Included participants from 30 milligrams (mg) group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection once every week (Q1W) for the first 3 doses and once every 2 weeks (Q2W) until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection once every 4 weeks (Q4W) until Week 44.
|
80 mg LY2439821
Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
|
160 mg LY2439821
Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
17
|
|
Overall Study
COMPLETED
|
4
|
4
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
3
|
Reasons for withdrawal
| Measure |
30 mg LY2439821
Included participants from 30 milligrams (mg) group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection once every week (Q1W) for the first 3 doses and once every 2 weeks (Q2W) until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection once every 4 weeks (Q4W) until Week 44.
|
80 mg LY2439821
Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
|
160 mg LY2439821
Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
A Study of LY2439821 in Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
30 mg LY2439821
n=6 Participants
Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
|
80 mg LY2439821
n=5 Participants
Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 Q1W subcutaneous injection for the first 3 doses and then Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
|
160 mg LY2439821
n=17 Participants
Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 Q2W subcutaneous injection for the first 3 doses then Q4W until Week 44.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
61.2 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
28 Participants
n=4 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
|
|
Race/Ethnicity, Customized
Asian
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
17 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
17 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
Weight
|
54.23 kilograms (kg)
STANDARD_DEVIATION 9.69 • n=5 Participants
|
54.12 kilograms (kg)
STANDARD_DEVIATION 7.66 • n=7 Participants
|
61.25 kilograms (kg)
STANDARD_DEVIATION 15.55 • n=5 Participants
|
58.47 kilograms (kg)
STANDARD_DEVIATION 13.48 • n=4 Participants
|
|
Height
|
161.62 centimeters (cm)
STANDARD_DEVIATION 9.62 • n=5 Participants
|
152.34 centimeters (cm)
STANDARD_DEVIATION 6.20 • n=7 Participants
|
159.52 centimeters (cm)
STANDARD_DEVIATION 8.87 • n=5 Participants
|
158.69 centimeters (cm)
STANDARD_DEVIATION 8.90 • n=4 Participants
|
|
Body Mass Index (BMI)
|
20.68 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 2.37 • n=5 Participants
|
23.38 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.50 • n=7 Participants
|
23.95 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 5.28 • n=5 Participants
|
23.15 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 4.60 • n=4 Participants
|
|
Weekly Dose of Methotrexate (MTX)
|
9.08 milligrams per week (mg/week)
STANDARD_DEVIATION 1.86 • n=5 Participants
|
8.40 milligrams per week (mg/week)
STANDARD_DEVIATION 0.89 • n=7 Participants
|
8.35 milligrams per week (mg/week)
STANDARD_DEVIATION 0.79 • n=5 Participants
|
8.52 milligrams per week (mg/week)
STANDARD_DEVIATION 1.10 • n=4 Participants
|
|
Number of Participants Given Doses in Study I1F-JE-RHAL (NCT01253265)
LY2439821
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
14 participants
n=5 Participants
|
22 participants
n=4 Participants
|
|
Number of Participants Given Doses in Study I1F-JE-RHAL (NCT01253265)
Placebo
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline through study completion (up to Week 56)Population: All enrolled participants.
Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report.
Outcome measures
| Measure |
30 mg LY2439821
n=6 Participants
Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
|
80 mg LY2439821
n=5 Participants
Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 Q1W subcutaneous injection for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
|
160 mg LY2439821
n=17 Participants
Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) [Clinically Significant Events]
SAEs
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AEs) [Clinically Significant Events]
AEs (All Causalities)
|
6 participants
|
5 participants
|
16 participants
|
|
Number of Participants With Adverse Events (AEs) [Clinically Significant Events]
AEs (Drug-Related)
|
3 participants
|
4 participants
|
7 participants
|
Adverse Events
30 mg LY2439821
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
80 mg LY2439821
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
160 mg LY2439821
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
30 mg LY2439821
n=6 participants at risk
Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
|
80 mg LY2439821
n=5 participants at risk
Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
|
160 mg LY2439821
n=17 participants at risk
Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Eczema infected
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Vascular disorders
Aortic dissection
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
Other adverse events
| Measure |
30 mg LY2439821
n=6 participants at risk
Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
|
80 mg LY2439821
n=5 participants at risk
Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
|
160 mg LY2439821
n=17 participants at risk
Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Eye disorders
Eyelid oedema
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6
|
0.00%
0/5
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis atrophic
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Gastrointestinal disorders
Gingivitis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Hiatus hernia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Gastrointestinal disorders
Lip swelling
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2
|
0.00%
0/5
|
0.00%
0/17
|
|
General disorders
Administration site reaction
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 13
|
|
General disorders
Injection site erythema
|
16.7%
1/6 • Number of events 17
|
20.0%
1/5 • Number of events 11
|
5.9%
1/17 • Number of events 2
|
|
General disorders
Injection site induration
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/6
|
0.00%
0/5
|
11.8%
2/17 • Number of events 2
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6
|
0.00%
0/5
|
11.8%
2/17 • Number of events 2
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/17
|
|
Infections and infestations
Herpes zoster
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Infections and infestations
Influenza
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/17
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
23.5%
4/17 • Number of events 4
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Systemic mycosis
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/17
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6
|
0.00%
0/5
|
11.8%
2/17 • Number of events 3
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 2
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Thermal burn
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6
|
0.00%
0/5
|
11.8%
2/17 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6
|
0.00%
0/5
|
11.8%
2/17 • Number of events 3
|
|
Investigations
Blood urea increased
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Eosinophil count increased
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 3
|
|
Investigations
Hepatitis b dna assay positive
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/17
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
11.8%
2/17 • Number of events 2
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Weight increased
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
11.8%
2/17 • Number of events 2
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Hand deformity
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
33.3%
2/6 • Number of events 2
|
0.00%
0/5
|
23.5%
4/17 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/17
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 4
|
|
Nervous system disorders
Headache
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/17
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis palmaris and plantaris
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Surgical and medical procedures
Cardioversion
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
|
Surgical and medical procedures
Skin operation
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/17
|
|
Vascular disorders
Haematoma
|
0.00%
0/6
|
0.00%
0/5
|
5.9%
1/17 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60