Trial Outcomes & Findings for A Study of LY2495655 in Older Participants Undergoing Elective Total Hip Replacement (NCT NCT01369511)
NCT ID: NCT01369511
Last Updated: 2018-06-06
Results Overview
The percentage change in aLBM of 3 limbs (excluding the operated limb) was measured by dual energy x-ray absorptiometry (DEXA). Least squares (LS) means of the aLBM change from baseline to the 12 week endpoint was adjusted by baseline aLBM values as a covariate and treatment, visit, and the treatment-by-visit interaction were included as fixed effect via a mixed-effects model for repeated measured (MMRM) analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
400 participants
Primary outcome timeframe
Baseline, 12 Weeks
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
Placebo
Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
35 mg LY2495655
LY2495655: 35 milligrams (mg) administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
105 mg LY2495655
LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
315 mg LY2495655
LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
98
|
104
|
98
|
100
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
98
|
103
|
98
|
100
|
|
Overall Study
COMPLETED
|
85
|
91
|
87
|
89
|
|
Overall Study
NOT COMPLETED
|
13
|
13
|
11
|
11
|
Reasons for withdrawal
| Measure |
Placebo
Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
35 mg LY2495655
LY2495655: 35 milligrams (mg) administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
105 mg LY2495655
LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
315 mg LY2495655
LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
5
|
0
|
|
Overall Study
Entry criteria not met
|
2
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
2
|
|
Overall Study
Physician Decision
|
3
|
4
|
0
|
0
|
|
Overall Study
Sponsor decision
|
2
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
4
|
6
|
Baseline Characteristics
A Study of LY2495655 in Older Participants Undergoing Elective Total Hip Replacement
Baseline characteristics by cohort
| Measure |
Placebo
n=98 Participants
Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
35 mg LY2495655
n=104 Participants
LY2495655: 35 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
105 mg LY2495666
n=98 Participants
LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
315 mg LY2495655
n=100 Participants
LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
69.38 years
STANDARD_DEVIATION 8.90 • n=93 Participants
|
68.66 years
STANDARD_DEVIATION 8.09 • n=4 Participants
|
67.85 years
STANDARD_DEVIATION 8.14 • n=27 Participants
|
68.71 years
STANDARD_DEVIATION 7.95 • n=483 Participants
|
68.65 years
STANDARD_DEVIATION 8.26 • n=36 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
54 Participants
n=483 Participants
|
234 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
46 Participants
n=483 Participants
|
166 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
55 Participants
n=483 Participants
|
214 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
45 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
45 Participants
n=483 Participants
|
184 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
46 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=93 Participants
|
89 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
88 Participants
n=483 Participants
|
349 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
113 Participants
n=36 Participants
|
|
Region of Enrollment
Estonia
|
11 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
41 Participants
n=36 Participants
|
|
Region of Enrollment
Canada
|
16 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
74 Participants
n=36 Participants
|
|
Region of Enrollment
Finland
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
|
Region of Enrollment
Belgium
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
20 Participants
n=36 Participants
|
|
Region of Enrollment
Spain
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
26 Participants
n=36 Participants
|
|
Region of Enrollment
Austria
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
|
Region of Enrollment
Denmark
|
11 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
34 Participants
n=36 Participants
|
|
Region of Enrollment
Japan
|
11 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
45 Participants
n=36 Participants
|
|
Region of Enrollment
Sweden
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Body Mass Index (BMI)
|
28.58 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 4.82 • n=93 Participants
|
28.78 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 4.94 • n=4 Participants
|
28.14 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 4.31 • n=27 Participants
|
28.51 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 4.47 • n=483 Participants
|
28.51 kilograms per meter squared (kg/m^2)
STANDARD_DEVIATION 4.63 • n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Randomized participants with non-missing baseline and at least 1 post-baseline aLBM measure.
The percentage change in aLBM of 3 limbs (excluding the operated limb) was measured by dual energy x-ray absorptiometry (DEXA). Least squares (LS) means of the aLBM change from baseline to the 12 week endpoint was adjusted by baseline aLBM values as a covariate and treatment, visit, and the treatment-by-visit interaction were included as fixed effect via a mixed-effects model for repeated measured (MMRM) analysis.
Outcome measures
| Measure |
Placebo
n=70 Participants
Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
35 mg LY2495655
n=68 Participants
LY2495655: 35 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
105 mg LY2495655
n=76 Participants
LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
315 mg LY2495655
n=69 Participants
LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
|---|---|---|---|---|
|
Change From Baseline in Appendicular Lean Body Mass (aLBM) at Week 12
|
0.297 percentage change in aLBM (3 limbs)
Standard Error 0.492
|
0.741 percentage change in aLBM (3 limbs)
Standard Error 0.500
|
1.018 percentage change in aLBM (3 limbs)
Standard Error 0.471
|
1.357 percentage change in aLBM (3 limbs)
Standard Error 0.494
|
SECONDARY outcome
Timeframe: Baseline, 4 Weeks, 8 Weeks, and 16 WeeksPopulation: Randomized participants with non-missing baseline and at least 1 post-baseline aLBM measure.
The percentage change in aLBM of 3 limbs (excluding the operated limb) was measured by DEXA. LS means of the aLBM change from baseline to the 12 week endpoint was adjusted by baseline aLBM values as a covariate and treatment, visit, and the treatment-by-visit interaction were included as fixed effect via an MMRM analysis.
Outcome measures
| Measure |
Placebo
n=74 Participants
Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
35 mg LY2495655
n=69 Participants
LY2495655: 35 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
105 mg LY2495655
n=80 Participants
LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
315 mg LY2495655
n=72 Participants
LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
|---|---|---|---|---|
|
Change From Baseline in Appendicular Lean Body Mass (aLBM) at Weeks 4, 8, and 16
Week 4
|
NA percentage change in aLBM (3 limbs)
Standard Error NA
Data were not collected for this time point and not planned in the protocol because it was too close to the surgery date and associated swelling would confound results.
|
NA percentage change in aLBM (3 limbs)
Standard Error NA
Data were not collected for this time point and not planned in the protocol because it was too close to the surgery date and associated swelling would confound results.
|
NA percentage change in aLBM (3 limbs)
Standard Error NA
Data were not collected for this time point and not planned in the protocol because it was too close to the surgery date and associated swelling would confound results.
|
NA percentage change in aLBM (3 limbs)
Standard Error NA
Data were not collected for this time point and not planned in the protocol because it was too close to the surgery date and associated swelling would confound results.
|
|
Change From Baseline in Appendicular Lean Body Mass (aLBM) at Weeks 4, 8, and 16
Week 8
|
-0.900 percentage change in aLBM (3 limbs)
Standard Error 0.485
|
-0.680 percentage change in aLBM (3 limbs)
Standard Error 0.498
|
0.340 percentage change in aLBM (3 limbs)
Standard Error 0.466
|
0.585 percentage change in aLBM (3 limbs)
Standard Error 0.488
|
|
Change From Baseline in Appendicular Lean Body Mass (aLBM) at Weeks 4, 8, and 16
Week 16
|
-0.102 percentage change in aLBM (3 limbs)
Standard Error 0.494
|
0.606 percentage change in aLBM (3 limbs)
Standard Error 0.502
|
2.058 percentage change in aLBM (3 limbs)
Standard Error 0.467
|
1.784 percentage change in aLBM (3 limbs)
Standard Error 0.494
|
Adverse Events
Placebo
Serious events: 14 serious events
Other events: 72 other events
Deaths: 0 deaths
35 mg LY2495655
Serious events: 8 serious events
Other events: 76 other events
Deaths: 0 deaths
105 mg LY2495655
Serious events: 16 serious events
Other events: 66 other events
Deaths: 0 deaths
315 mg LY2495655
Serious events: 3 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=98 participants at risk
Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
35 mg LY2495655
n=104 participants at risk
LY2495655: 35 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
105 mg LY2495655
n=98 participants at risk
LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
315 mg LY2495655
n=100 participants at risk
LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/98
|
0.00%
0/104
|
1.0%
1/98 • Number of events 1
|
0.00%
0/100
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/98
|
0.00%
0/104
|
1.0%
1/98 • Number of events 1
|
0.00%
0/100
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/98
|
0.96%
1/104 • Number of events 1
|
0.00%
0/98
|
0.00%
0/100
|
|
Cardiac disorders
Sick sinus syndrome
|
1.0%
1/98 • Number of events 1
|
0.00%
0/104
|
0.00%
0/98
|
0.00%
0/100
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/98
|
0.00%
0/104
|
1.0%
1/98 • Number of events 1
|
0.00%
0/100
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/98
|
0.00%
0/104
|
1.0%
1/98 • Number of events 1
|
0.00%
0/100
|
|
General disorders
Device dislocation
|
0.00%
0/98
|
0.00%
0/104
|
1.0%
1/98 • Number of events 1
|
0.00%
0/100
|
|
General disorders
Oedema peripheral
|
0.00%
0/98
|
0.96%
1/104 • Number of events 1
|
0.00%
0/98
|
0.00%
0/100
|
|
General disorders
Pyrexia
|
0.00%
0/98
|
0.96%
1/104 • Number of events 1
|
0.00%
0/98
|
0.00%
0/100
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/98
|
0.00%
0/104
|
1.0%
1/98 • Number of events 1
|
0.00%
0/100
|
|
Infections and infestations
Pneumonia
|
1.0%
1/98 • Number of events 1
|
0.00%
0/104
|
1.0%
1/98 • Number of events 1
|
0.00%
0/100
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/98
|
0.00%
0/104
|
1.0%
1/98 • Number of events 1
|
0.00%
0/100
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/98
|
0.00%
0/104
|
2.0%
2/98 • Number of events 2
|
2.0%
2/100 • Number of events 2
|
|
Injury, poisoning and procedural complications
Confusion postoperative
|
0.00%
0/98
|
0.00%
0/104
|
1.0%
1/98 • Number of events 1
|
0.00%
0/100
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
2/98 • Number of events 2
|
0.00%
0/104
|
0.00%
0/98
|
0.00%
0/100
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/98
|
0.00%
0/104
|
1.0%
1/98 • Number of events 1
|
0.00%
0/100
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
2.0%
2/98 • Number of events 2
|
0.00%
0/104
|
0.00%
0/98
|
0.00%
0/100
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
1.0%
1/98 • Number of events 1
|
0.00%
0/104
|
0.00%
0/98
|
0.00%
0/100
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/98
|
0.96%
1/104 • Number of events 1
|
0.00%
0/98
|
0.00%
0/100
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
1.0%
1/98 • Number of events 1
|
0.00%
0/104
|
0.00%
0/98
|
0.00%
0/100
|
|
Investigations
Blood creatinine increased
|
0.00%
0/98
|
0.96%
1/104 • Number of events 1
|
0.00%
0/98
|
0.00%
0/100
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/98
|
0.96%
1/104 • Number of events 1
|
0.00%
0/98
|
0.00%
0/100
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.0%
1/98 • Number of events 1
|
0.00%
0/104
|
0.00%
0/98
|
0.00%
0/100
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/98
|
0.00%
0/104
|
1.0%
1/98 • Number of events 1
|
0.00%
0/100
|
|
Musculoskeletal and connective tissue disorders
Joint ankylosis
|
0.00%
0/98
|
0.00%
0/104
|
1.0%
1/98 • Number of events 1
|
0.00%
0/100
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.1%
3/98 • Number of events 3
|
0.96%
1/104 • Number of events 1
|
1.0%
1/98 • Number of events 1
|
0.00%
0/100
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/98
|
0.96%
1/104 • Number of events 1
|
0.00%
0/98
|
0.00%
0/100
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/98
|
0.96%
1/104 • Number of events 1
|
0.00%
0/98
|
0.00%
0/100
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/98
|
0.00%
0/104
|
1.0%
1/98 • Number of events 1
|
0.00%
0/100
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/98
|
0.00%
0/104
|
0.00%
0/98
|
1.0%
1/100 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/98
|
0.00%
0/104
|
2.1%
1/47 • Number of events 1
|
0.00%
0/100
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
1/98 • Number of events 1
|
0.00%
0/104
|
0.00%
0/98
|
0.00%
0/100
|
|
Nervous system disorders
Encephalopathy
|
1.0%
1/98 • Number of events 1
|
0.00%
0/104
|
0.00%
0/98
|
0.00%
0/100
|
|
Nervous system disorders
Metabolic encephalopathy
|
1.0%
1/98 • Number of events 1
|
0.00%
0/104
|
0.00%
0/98
|
0.00%
0/100
|
|
Psychiatric disorders
Alcohol abuse
|
1.0%
1/98 • Number of events 1
|
0.00%
0/104
|
0.00%
0/98
|
0.00%
0/100
|
|
Psychiatric disorders
Delirium
|
1.0%
1/98 • Number of events 1
|
0.00%
0/104
|
0.00%
0/98
|
0.00%
0/100
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/98
|
0.96%
1/104 • Number of events 1
|
0.00%
0/98
|
0.00%
0/100
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/98
|
0.00%
0/104
|
1.0%
1/98 • Number of events 1
|
0.00%
0/100
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.0%
1/98 • Number of events 1
|
0.00%
0/104
|
0.00%
0/98
|
0.00%
0/100
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.0%
1/98 • Number of events 1
|
0.00%
0/104
|
0.00%
0/98
|
1.0%
1/100 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.0%
1/98 • Number of events 1
|
0.00%
0/104
|
0.00%
0/98
|
0.00%
0/100
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
1.0%
1/98 • Number of events 1
|
0.00%
0/104
|
0.00%
0/98
|
0.00%
0/100
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/98
|
0.00%
0/104
|
1.0%
1/98 • Number of events 1
|
0.00%
0/100
|
Other adverse events
| Measure |
Placebo
n=98 participants at risk
Administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
35 mg LY2495655
n=104 participants at risk
LY2495655: 35 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
105 mg LY2495655
n=98 participants at risk
LY2495655: 105 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
315 mg LY2495655
n=100 participants at risk
LY2495655: 315 mg administered subcutaneously every 4 weeks for 12 weeks (administered 4 times)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.1%
4/98 • Number of events 4
|
7.7%
8/104 • Number of events 8
|
7.1%
7/98 • Number of events 7
|
11.0%
11/100 • Number of events 11
|
|
Gastrointestinal disorders
Constipation
|
8.2%
8/98 • Number of events 9
|
13.5%
14/104 • Number of events 15
|
7.1%
7/98 • Number of events 7
|
9.0%
9/100 • Number of events 9
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
2/98 • Number of events 2
|
7.7%
8/104 • Number of events 8
|
4.1%
4/98 • Number of events 4
|
5.0%
5/100 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
12.2%
12/98 • Number of events 12
|
19.2%
20/104 • Number of events 23
|
16.3%
16/98 • Number of events 18
|
21.0%
21/100 • Number of events 21
|
|
Gastrointestinal disorders
Vomiting
|
9.2%
9/98 • Number of events 10
|
15.4%
16/104 • Number of events 20
|
9.2%
9/98 • Number of events 11
|
12.0%
12/100 • Number of events 12
|
|
General disorders
Fatigue
|
7.1%
7/98 • Number of events 9
|
3.8%
4/104 • Number of events 4
|
4.1%
4/98 • Number of events 4
|
9.0%
9/100 • Number of events 9
|
|
General disorders
Injection site erythema
|
0.00%
0/98
|
0.96%
1/104 • Number of events 1
|
2.0%
2/98 • Number of events 3
|
6.0%
6/100 • Number of events 11
|
|
General disorders
Injection site pain
|
3.1%
3/98 • Number of events 3
|
5.8%
6/104 • Number of events 9
|
13.3%
13/98 • Number of events 30
|
12.0%
12/100 • Number of events 30
|
|
General disorders
Local swelling
|
5.1%
5/98 • Number of events 5
|
5.8%
6/104 • Number of events 6
|
7.1%
7/98 • Number of events 7
|
3.0%
3/100 • Number of events 3
|
|
General disorders
Pyrexia
|
11.2%
11/98 • Number of events 15
|
17.3%
18/104 • Number of events 22
|
13.3%
13/98 • Number of events 24
|
14.0%
14/100 • Number of events 14
|
|
Infections and infestations
Influenza
|
6.1%
6/98 • Number of events 6
|
0.96%
1/104 • Number of events 1
|
2.0%
2/98 • Number of events 2
|
2.0%
2/100 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
1.0%
1/98 • Number of events 1
|
2.9%
3/104 • Number of events 4
|
2.0%
2/98 • Number of events 2
|
6.0%
6/100 • Number of events 7
|
|
Infections and infestations
Urinary tract infection
|
3.1%
3/98 • Number of events 3
|
2.9%
3/104 • Number of events 4
|
3.1%
3/98 • Number of events 3
|
5.0%
5/100 • Number of events 6
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
2.0%
2/98 • Number of events 2
|
2.9%
3/104 • Number of events 4
|
2.0%
2/98 • Number of events 2
|
6.0%
6/100 • Number of events 6
|
|
Investigations
Oxygen saturation decreased
|
7.1%
7/98 • Number of events 7
|
2.9%
3/104 • Number of events 3
|
3.1%
3/98 • Number of events 3
|
6.0%
6/100 • Number of events 6
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.1%
3/98 • Number of events 3
|
1.9%
2/104 • Number of events 2
|
1.0%
1/98 • Number of events 1
|
9.0%
9/100 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.2%
11/98 • Number of events 15
|
21.2%
22/104 • Number of events 30
|
11.2%
11/98 • Number of events 12
|
14.0%
14/100 • Number of events 23
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
3/98 • Number of events 4
|
8.7%
9/104 • Number of events 9
|
12.2%
12/98 • Number of events 14
|
2.0%
2/100 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
3/98 • Number of events 3
|
8.7%
9/104 • Number of events 10
|
3.1%
3/98 • Number of events 4
|
4.0%
4/100 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
3/98 • Number of events 3
|
10.6%
11/104 • Number of events 13
|
5.1%
5/98 • Number of events 6
|
4.0%
4/100 • Number of events 7
|
|
Nervous system disorders
Dizziness
|
13.3%
13/98 • Number of events 16
|
8.7%
9/104 • Number of events 13
|
6.1%
6/98 • Number of events 7
|
9.0%
9/100 • Number of events 11
|
|
Nervous system disorders
Headache
|
0.00%
0/98
|
5.8%
6/104 • Number of events 6
|
3.1%
3/98 • Number of events 4
|
2.0%
2/100 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
3.1%
3/98 • Number of events 3
|
6.7%
7/104 • Number of events 7
|
7.1%
7/98 • Number of events 8
|
5.0%
5/100 • Number of events 5
|
|
Renal and urinary disorders
Urinary retention
|
8.2%
8/98 • Number of events 8
|
4.8%
5/104 • Number of events 5
|
9.2%
9/98 • Number of events 9
|
8.0%
8/100 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
7/98 • Number of events 8
|
2.9%
3/104 • Number of events 3
|
2.0%
2/98 • Number of events 2
|
3.0%
3/100 • Number of events 3
|
|
Vascular disorders
Hypertension
|
6.1%
6/98 • Number of events 6
|
2.9%
3/104 • Number of events 3
|
3.1%
3/98 • Number of events 3
|
1.0%
1/100 • Number of events 1
|
|
Vascular disorders
Hypotension
|
9.2%
9/98 • Number of events 11
|
8.7%
9/104 • Number of events 10
|
10.2%
10/98 • Number of events 10
|
12.0%
12/100 • Number of events 12
|
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