Trial Outcomes & Findings for A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer (NCT NCT01505530)
NCT ID: NCT01505530
Last Updated: 2019-09-18
Results Overview
Overall survival (OS) duration was measured from the date of randomization to the date of death from any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
125 participants
Primary outcome timeframe
Baseline to Death from Any Cause (Up to 23 months)
Results posted on
2019-09-18
Participant Flow
The reasons for discontinuation listed in the participant flow are the reasons the participant discontinued treatment and a participant was considered to have "completed" the trial if they died due to any cause while on study or completed treatment and was known to be alive at the last scheduled follow-up.
Participant milestones
| Measure |
300 mg LY2495655 + Chemotherapy
300 milligram (mg) LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
100 mg LY2495655 + Chemotherapy
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
Placebo + Chemotherapy
Placebo in combination with standard of care chemotherapy (investigator's choice).
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
43
|
41
|
|
Overall Study
Received At Least One Dose of Study Drug
|
41
|
42
|
41
|
|
Overall Study
Completed One Cycle of Study Drug
|
29
|
27
|
31
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
41
|
43
|
41
|
Reasons for withdrawal
| Measure |
300 mg LY2495655 + Chemotherapy
300 milligram (mg) LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
100 mg LY2495655 + Chemotherapy
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
Placebo + Chemotherapy
Placebo in combination with standard of care chemotherapy (investigator's choice).
|
|---|---|---|---|
|
Overall Study
Progressive Disease
|
19
|
17
|
18
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
8
|
6
|
|
Overall Study
Physician Decision
|
6
|
2
|
5
|
|
Overall Study
Sponsor Decision
|
1
|
8
|
7
|
|
Overall Study
Death
|
7
|
6
|
5
|
|
Overall Study
entry criteria not met
|
0
|
1
|
0
|
Baseline Characteristics
A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
300 mg LY2495655 + Chemotherapy
n=41 Participants
300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
100 mg LY2495655 + Chemotherapy
n=43 Participants
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
Placebo + Chemotherapy
n=41 Participants
Placebo in combination with standard of care chemotherapy (investigator's choice).
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.0 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
67.4 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
68.4 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
66.9 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Death from Any Cause (Up to 23 months)Population: All randomized participants. Participants who were alive at data cut-off for the OS analysis or lost to follow-up were censored on the last date the participant was known to be alive. Censored participants; 300 mg LY2495655 = 9,100 mg LY2495655 =13, Placebo= 16.
Overall survival (OS) duration was measured from the date of randomization to the date of death from any cause.
Outcome measures
| Measure |
300 mg LY2495655 + Chemotherapy
n=41 Participants
300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
100 mg LY2495655 + Chemotherapy
n=43 Participants
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
Placebo + Chemotherapy
n=41 Participants
Placebo in combination with standard of care chemotherapy (investigator's choice).
|
|---|---|---|---|
|
Overall Survival (OS)
|
8.02 months
Interval 5.95 to 10.02
|
9.82 months
Interval 5.85 to 13.54
|
10.45 months
Interval 8.38 to 14.49
|
SECONDARY outcome
Timeframe: Baseline to Disease Progression or Death from Any Cause (Up to 16 months)Population: All randomized participants.
PFS was defined as the time from date of first dose to the first observation of disease progression or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Outcome measures
| Measure |
300 mg LY2495655 + Chemotherapy
n=41 Participants
300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
100 mg LY2495655 + Chemotherapy
n=43 Participants
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
Placebo + Chemotherapy
n=41 Participants
Placebo in combination with standard of care chemotherapy (investigator's choice).
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
4.90 months
Interval 3.32 to 6.01
|
6.87 months
Interval 5.36 to 7.89
|
8.21 months
Interval 4.99 to 9.36
|
SECONDARY outcome
Timeframe: Baseline to Disease Progression (Up to 11 months)Population: All randomized participants.
Response rate (RR) was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria.
Outcome measures
| Measure |
300 mg LY2495655 + Chemotherapy
n=41 Participants
300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
100 mg LY2495655 + Chemotherapy
n=43 Participants
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
Placebo + Chemotherapy
n=41 Participants
Placebo in combination with standard of care chemotherapy (investigator's choice).
|
|---|---|---|---|
|
Percentage of Participants With Tumor Response Rate (RR)
|
22 percentage of participants
|
25.6 percentage of participants
|
26.8 percentage of participants
|
SECONDARY outcome
Timeframe: First CR or PR to Disease Progression (Up to 11 months)Population: All randomized participants.
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 millimeters (mm). Partial Response (PR) was defined as having at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.
Outcome measures
| Measure |
300 mg LY2495655 + Chemotherapy
n=41 Participants
300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
100 mg LY2495655 + Chemotherapy
n=43 Participants
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
Placebo + Chemotherapy
n=41 Participants
Placebo in combination with standard of care chemotherapy (investigator's choice).
|
|---|---|---|---|
|
Duration of Response
|
5.86 months
Interval 3.91 to 5.98
|
8.02 months
Interval 3.09 to 9.63
|
9.20 months
Interval 9.03 to 10.45
|
SECONDARY outcome
Timeframe: Baseline, Cycles 3, 5, 7, 9 and 11; Day 1Population: All participants that received at least one dose of study drug and had evaluable post-baseline measurements.
Change in lean body mass was assessed using dual-energy x-ray absorptiometry (DXA).
Outcome measures
| Measure |
300 mg LY2495655 + Chemotherapy
n=41 Participants
300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
100 mg LY2495655 + Chemotherapy
n=42 Participants
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
Placebo + Chemotherapy
n=41 Participants
Placebo in combination with standard of care chemotherapy (investigator's choice).
|
|---|---|---|---|
|
Change in Lean Body Mass
Cycle 9
|
46879.22 grams (g)
Standard Deviation 12316.64
|
43656.49 grams (g)
Standard Deviation 12335.08
|
43405.26 grams (g)
Standard Deviation 7217.48
|
|
Change in Lean Body Mass
Baseline
|
43742.92 grams (g)
Standard Deviation 10460.69
|
44307.12 grams (g)
Standard Deviation 9853.15
|
42870.99 grams (g)
Standard Deviation 8971.73
|
|
Change in Lean Body Mass
Cycle 3
|
42629.79 grams (g)
Standard Deviation 10263.53
|
44250.67 grams (g)
Standard Deviation 11600.33
|
42282.45 grams (g)
Standard Deviation 8523.35
|
|
Change in Lean Body Mass
Cycle 5
|
43121.85 grams (g)
Standard Deviation 11249.28
|
45697.82 grams (g)
Standard Deviation 12035.96
|
43041.45 grams (g)
Standard Deviation 7649.44
|
|
Change in Lean Body Mass
Cycle 7
|
44407.02 grams (g)
Standard Deviation 11685.15
|
45486.34 grams (g)
Standard Deviation 11424.00
|
45997.59 grams (g)
Standard Deviation 9429.50
|
|
Change in Lean Body Mass
Cycle 11
|
46155.53 grams (g)
Standard Deviation 9984.09
|
433316.42 grams (g)
Standard Deviation 11436.93
|
45667.63 grams (g)
Standard Deviation 8100.86
|
SECONDARY outcome
Timeframe: Baseline, Cycles 2, 4, 6, 8 and 10; Day 1Population: All participants that received at least one dose of study drug and had evaluable post-baseline measurements.
Hand grip strength (HGS) of the non-dominant hand measured using a hand dynamometer.
Outcome measures
| Measure |
300 mg LY2495655 + Chemotherapy
n=41 Participants
300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
100 mg LY2495655 + Chemotherapy
n=42 Participants
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
Placebo + Chemotherapy
n=41 Participants
Placebo in combination with standard of care chemotherapy (investigator's choice).
|
|---|---|---|---|
|
Change in Physical Performance Measures Using Hand Grip Strength
Baseline
|
28.59 kilogram (kg)
Standard Deviation 11.99
|
29.00 kilogram (kg)
Standard Deviation 11.35
|
27.46 kilogram (kg)
Standard Deviation 12.54
|
|
Change in Physical Performance Measures Using Hand Grip Strength
Cycle 2
|
25.90 kilogram (kg)
Standard Deviation 13.49
|
26.70 kilogram (kg)
Standard Deviation 12.27
|
25.26 kilogram (kg)
Standard Deviation 11.80
|
|
Change in Physical Performance Measures Using Hand Grip Strength
Cycle 4
|
25.56 kilogram (kg)
Standard Deviation 13.67
|
24.47 kilogram (kg)
Standard Deviation 10.46
|
28.02 kilogram (kg)
Standard Deviation 13.10
|
|
Change in Physical Performance Measures Using Hand Grip Strength
Cycle 6
|
26.58 kilogram (kg)
Standard Deviation 9.65
|
26.32 kilogram (kg)
Standard Deviation 14.33
|
27.43 kilogram (kg)
Standard Deviation 14.01
|
|
Change in Physical Performance Measures Using Hand Grip Strength
Cycle 8
|
27.89 kilogram (kg)
Standard Deviation 11.46
|
26.22 kilogram (kg)
Standard Deviation 14.92
|
25.44 kilogram (kg)
Standard Deviation 12.05
|
|
Change in Physical Performance Measures Using Hand Grip Strength
Cycle 10
|
25.13 kilogram (kg)
Standard Deviation 13.15
|
29.23 kilogram (kg)
Standard Deviation 14.81
|
33.27 kilogram (kg)
Standard Deviation 14.25
|
SECONDARY outcome
Timeframe: Baseline, Cycles 2, 4, 6, 8 and 10; Day 1Population: All participants that received at least one dose of study drug and had evaluable post-baseline measurements.
Time Up and Go (TUG) is a timed walking test designed to measure gait performance and balance. It measures in seconds the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm \[18in\], arm height 65 cm \[25.6 in\]), walk a distance of 3 meters (118 inches, approximately 10 feet), turn, walk back to the chair, and sit down.
Outcome measures
| Measure |
300 mg LY2495655 + Chemotherapy
n=41 Participants
300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
100 mg LY2495655 + Chemotherapy
n=42 Participants
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
Placebo + Chemotherapy
n=41 Participants
Placebo in combination with standard of care chemotherapy (investigator's choice).
|
|---|---|---|---|
|
Change in Physical Performance Measures Using the Time Up and Go (TUG) Test
Baseline
|
10.70 seconds
Standard Deviation 5.06
|
10.16 seconds
Standard Deviation 4.53
|
10.04 seconds
Standard Deviation 4.04
|
|
Change in Physical Performance Measures Using the Time Up and Go (TUG) Test
Cycle 2
|
9.19 seconds
Standard Deviation 2.60
|
10.15 seconds
Standard Deviation 3.93
|
10.64 seconds
Standard Deviation 4.46
|
|
Change in Physical Performance Measures Using the Time Up and Go (TUG) Test
Cycle 4
|
9.33 seconds
Standard Deviation 3.23
|
12.19 seconds
Standard Deviation 8.96
|
9.18 seconds
Standard Deviation 2.60
|
|
Change in Physical Performance Measures Using the Time Up and Go (TUG) Test
Cycle 6
|
10.14 seconds
Standard Deviation 2.02
|
8.84 seconds
Standard Deviation 2.94
|
9.77 seconds
Standard Deviation 3.96
|
|
Change in Physical Performance Measures Using the Time Up and Go (TUG) Test
Cycle 8
|
9.28 seconds
Standard Deviation 2.51
|
7.26 seconds
Standard Deviation 2.13
|
9.03 seconds
Standard Deviation 4.30
|
|
Change in Physical Performance Measures Using the Time Up and Go (TUG) Test
Cycle 10
|
10.56 seconds
Standard Deviation 1.40
|
7.75 seconds
Standard Deviation 2.38
|
9.76 seconds
Standard Deviation 5.75
|
SECONDARY outcome
Timeframe: Baseline, Cycles 2, 4, 6, 8 and 10; Day 1Population: All participants that received at least one dose of study drug and had evaluable post-baseline measurements.
The 6 minute walk test measured the distance walked in 6 minutes, as quickly as possible, without running.
Outcome measures
| Measure |
300 mg LY2495655 + Chemotherapy
n=41 Participants
300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
100 mg LY2495655 + Chemotherapy
n=42 Participants
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
Placebo + Chemotherapy
n=41 Participants
Placebo in combination with standard of care chemotherapy (investigator's choice).
|
|---|---|---|---|
|
Change in Physical Performance Measures Using the 6 Minute Walk Test
Baseline
|
351.49 meter
Standard Deviation 115.18
|
382.49 meter
Standard Deviation 131.41
|
381.62 meter
Standard Deviation 94.68
|
|
Change in Physical Performance Measures Using the 6 Minute Walk Test
Cycle 2
|
368.08 meter
Standard Deviation 137.65
|
361.53 meter
Standard Deviation 143.70
|
376.31 meter
Standard Deviation 107.25
|
|
Change in Physical Performance Measures Using the 6 Minute Walk Test
Cycle 4
|
379.90 meter
Standard Deviation 208.66
|
323.79 meter
Standard Deviation 140.26
|
386.48 meter
Standard Deviation 126.56
|
|
Change in Physical Performance Measures Using the 6 Minute Walk Test
Cycle 6
|
354.20 meter
Standard Deviation 104.74
|
416.30 meter
Standard Deviation 102.49
|
376.45 meter
Standard Deviation 132.05
|
|
Change in Physical Performance Measures Using the 6 Minute Walk Test
Cycle 8
|
365.00 meter
Standard Deviation 75.71
|
347.32 meter
Standard Deviation 203.49
|
392.13 meter
Standard Deviation 113.43
|
|
Change in Physical Performance Measures Using the 6 Minute Walk Test
Cycle 10
|
308.19 meter
Standard Deviation 57.23
|
372.15 meter
Standard Deviation 172.40
|
391.41 meter
Standard Deviation 143.18
|
SECONDARY outcome
Timeframe: Baseline, Cycles 3, 5, 7, 9 and 11; Day 1Population: All participants that received at least one dose of study drug and had evaluable post-baseline measurements.
Stair climbing time (StC) measured the ascend and descend of a flight of 12 steps (each step 18 cm high and 28 cm deep).
Outcome measures
| Measure |
300 mg LY2495655 + Chemotherapy
n=41 Participants
300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
100 mg LY2495655 + Chemotherapy
n=42 Participants
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
Placebo + Chemotherapy
n=41 Participants
Placebo in combination with standard of care chemotherapy (investigator's choice).
|
|---|---|---|---|
|
Change in Physical Performance Measures Using Stair Climbing Time (StC)
Baseline
|
211.25 joule/second
Standard Deviation 129.57
|
206.92 joule/second
Standard Deviation 110.52
|
178.25 joule/second
Standard Deviation 65.18
|
|
Change in Physical Performance Measures Using Stair Climbing Time (StC)
Cycle 3
|
203.24 joule/second
Standard Deviation 113.76
|
203.70 joule/second
Standard Deviation 87.82
|
170.49 joule/second
Standard Deviation 76.52
|
|
Change in Physical Performance Measures Using Stair Climbing Time (StC)
Cycle 5
|
230.23 joule/second
Standard Deviation 135.31
|
211.99 joule/second
Standard Deviation 93.00
|
186.55 joule/second
Standard Deviation 95.20
|
|
Change in Physical Performance Measures Using Stair Climbing Time (StC)
Cycle 7
|
198.24 joule/second
Standard Deviation 83.19
|
235.82 joule/second
Standard Deviation 111.95
|
200.79 joule/second
Standard Deviation 130.74
|
|
Change in Physical Performance Measures Using Stair Climbing Time (StC)
Cycle 9
|
217.82 joule/second
Standard Deviation 131.34
|
197.49 joule/second
Standard Deviation 102.51
|
160.59 joule/second
Standard Deviation 87.60
|
|
Change in Physical Performance Measures Using Stair Climbing Time (StC)
Cycle 11
|
193.24 joule/second
Standard Deviation 96.70
|
221.59 joule/second
Standard Deviation 107.49
|
188.78 joule/second
Standard Deviation 188.78
|
SECONDARY outcome
Timeframe: Baseline, Cycles 2, 4, 6, 8 and 10; Day 1Population: Zero participants analyzed. An error in coding the scales (coded differently early and late in the study) occurred. Unable to determine which results were affected therefore analysis not completed.
Data from PRO scales are not be presented. An error in coding the scales (coded differently early and late in the study) occurred. Unable to determine which results were affected therefore analysis not completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Cycles 2, 4, 6, 8 and 10; Day 1Population: All randomized participants with evaluable SF-36 domain scores.
The 36-item Short-Form Health Survey (SF-36) pain scale is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). The PCS physical functioning domain score ranges from 0 to 100 (higher scores indicate better health status).
Outcome measures
| Measure |
300 mg LY2495655 + Chemotherapy
n=41 Participants
300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
100 mg LY2495655 + Chemotherapy
n=43 Participants
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
Placebo + Chemotherapy
n=41 Participants
Placebo in combination with standard of care chemotherapy (investigator's choice).
|
|---|---|---|---|
|
Change in Pain Scale Physical Functioning
Baseline
|
6.62 units on a scale
Standard Deviation 2.23
|
6.81 units on a scale
Standard Deviation 2.55
|
5.89 units on a scale
Standard Deviation 2.54
|
|
Change in Pain Scale Physical Functioning
Cycle 2
|
4.48 units on a scale
Standard Deviation 2.09
|
5.63 units on a scale
Standard Deviation 2.81
|
5.04 units on a scale
Standard Deviation 2.03
|
|
Change in Pain Scale Physical Functioning
Cycle 4
|
5.33 units on a scale
Standard Deviation 1.91
|
4.78 units on a scale
Standard Deviation 2.02
|
4.83 units on a scale
Standard Deviation 2.50
|
|
Change in Pain Scale Physical Functioning
Cycle 6
|
4.38 units on a scale
Standard Deviation 1.51
|
4.65 units on a scale
Standard Deviation 2.29
|
4.25 units on a scale
Standard Deviation 1.91
|
|
Change in Pain Scale Physical Functioning
Cycle 8
|
4.14 units on a scale
Standard Deviation 1.46
|
5.85 units on a scale
Standard Deviation 2.44
|
5.00 units on a scale
Standard Deviation 2.26
|
|
Change in Pain Scale Physical Functioning
Cycle 10
|
4.57 units on a scale
Standard Deviation 2.57
|
5.58 units on a scale
Standard Deviation 2.87
|
3.55 units on a scale
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 and Day 29 (Pre-Dose); Cycle 6 Day 1Population: All randomized participants.
Outcome measures
| Measure |
300 mg LY2495655 + Chemotherapy
n=41 Participants
300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
100 mg LY2495655 + Chemotherapy
n=43 Participants
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
|
Placebo + Chemotherapy
n=41 Participants
Placebo in combination with standard of care chemotherapy (investigator's choice).
|
|---|---|---|---|
|
Number of Participants With Anti-LY2495655 Antibodies
|
0 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
300 mg LY2495655
Serious events: 26 serious events
Other events: 41 other events
Deaths: 0 deaths
100 mg LY2495655
Serious events: 30 serious events
Other events: 41 other events
Deaths: 0 deaths
Placebo
Serious events: 25 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
300 mg LY2495655
n=41 participants at risk
300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
LY2495655: Intravenous (IV) treatment every 14 days while on study.
|
100 mg LY2495655
n=42 participants at risk
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
LY2495655: Intravenous (IV) treatment every 14 days while on study.
|
Placebo
n=41 participants at risk
Placebo in combination with standard of care chemotherapy (investigator's choice).
Placebo: Intravenous (IV) treatment every 14 days while on study.
|
|---|---|---|---|
|
General disorders
Pain
|
2.4%
1/41 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
14.6%
6/41 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
16.7%
7/42 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
12.2%
5/41 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
4.9%
2/41 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Splenic vein thrombosis
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.3%
3/41 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
9.5%
4/42 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
2.4%
1/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
4.9%
2/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
2/41 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
9.5%
4/42 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Device occlusion
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
2.4%
1/41 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
General disorders
General physical health deterioration
|
2.4%
1/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 15
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Infection
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Infusion site cellulitis
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Neutropenic sepsis
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
7.3%
3/41 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral labyrinthitis
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
2.4%
1/41 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.4%
1/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/41 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.4%
1/41 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
2.4%
1/41 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
4.9%
2/41 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/16
All randomized participants who received at least one dose of study drug.
|
7.7%
1/13 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
0.00%
0/15
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.9%
2/41 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.3%
3/41 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
2.4%
1/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Intra-abdominal haematoma
|
2.4%
1/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
300 mg LY2495655
n=41 participants at risk
300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
LY2495655: Intravenous (IV) treatment every 14 days while on study.
|
100 mg LY2495655
n=42 participants at risk
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
LY2495655: Intravenous (IV) treatment every 14 days while on study.
|
Placebo
n=41 participants at risk
Placebo in combination with standard of care chemotherapy (investigator's choice).
Placebo: Intravenous (IV) treatment every 14 days while on study.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
29.3%
12/41 • Number of events 58
All randomized participants who received at least one dose of study drug.
|
33.3%
14/42 • Number of events 63
All randomized participants who received at least one dose of study drug.
|
46.3%
19/41 • Number of events 58
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
29.3%
12/41 • Number of events 35
All randomized participants who received at least one dose of study drug.
|
21.4%
9/42 • Number of events 50
All randomized participants who received at least one dose of study drug.
|
31.7%
13/41 • Number of events 58
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
22.0%
9/41 • Number of events 28
All randomized participants who received at least one dose of study drug.
|
26.2%
11/42 • Number of events 37
All randomized participants who received at least one dose of study drug.
|
34.1%
14/41 • Number of events 46
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 13
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
29.3%
12/41 • Number of events 38
All randomized participants who received at least one dose of study drug.
|
14.3%
6/42 • Number of events 25
All randomized participants who received at least one dose of study drug.
|
24.4%
10/41 • Number of events 49
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
9.8%
4/41 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
9.5%
4/42 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
17.1%
7/41 • Number of events 22
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
29.3%
12/41 • Number of events 40
All randomized participants who received at least one dose of study drug.
|
33.3%
14/42 • Number of events 57
All randomized participants who received at least one dose of study drug.
|
22.0%
9/41 • Number of events 49
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
53.7%
22/41 • Number of events 51
All randomized participants who received at least one dose of study drug.
|
40.5%
17/42 • Number of events 65
All randomized participants who received at least one dose of study drug.
|
48.8%
20/41 • Number of events 61
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
14.6%
6/41 • Number of events 20
All randomized participants who received at least one dose of study drug.
|
9.5%
4/42 • Number of events 22
All randomized participants who received at least one dose of study drug.
|
14.6%
6/41 • Number of events 16
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.3%
3/41 • Number of events 15
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
7.3%
3/41 • Number of events 20
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
9.8%
4/41 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
43.9%
18/41 • Number of events 54
All randomized participants who received at least one dose of study drug.
|
45.2%
19/42 • Number of events 107
All randomized participants who received at least one dose of study drug.
|
43.9%
18/41 • Number of events 63
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
12.2%
5/41 • Number of events 20
All randomized participants who received at least one dose of study drug.
|
9.5%
4/42 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
31.7%
13/41 • Number of events 24
All randomized participants who received at least one dose of study drug.
|
33.3%
14/42 • Number of events 32
All randomized participants who received at least one dose of study drug.
|
34.1%
14/41 • Number of events 33
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
4.9%
2/41 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 13
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
7.3%
3/41 • Number of events 18
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 13
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
61.0%
25/41 • Number of events 131
All randomized participants who received at least one dose of study drug.
|
66.7%
28/42 • Number of events 138
All randomized participants who received at least one dose of study drug.
|
68.3%
28/41 • Number of events 151
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
12.2%
5/41 • Number of events 16
All randomized participants who received at least one dose of study drug.
|
9.5%
4/42 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
17.1%
7/41 • Number of events 26
All randomized participants who received at least one dose of study drug.
|
14.3%
6/42 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
22.0%
9/41 • Number of events 46
All randomized participants who received at least one dose of study drug.
|
33.3%
14/42 • Number of events 40
All randomized participants who received at least one dose of study drug.
|
34.1%
14/41 • Number of events 50
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
12.2%
5/41 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
11.9%
5/42 • Number of events 27
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
9.8%
4/41 • Number of events 16
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
31.7%
13/41 • Number of events 24
All randomized participants who received at least one dose of study drug.
|
26.2%
11/42 • Number of events 41
All randomized participants who received at least one dose of study drug.
|
31.7%
13/41 • Number of events 24
All randomized participants who received at least one dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
7.3%
3/41 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
4.9%
2/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
14.3%
6/42 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 18
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 13
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 18
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 15
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.4%
1/41 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 16
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
7.3%
3/41 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
9.5%
4/42 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
9.8%
4/41 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
12.2%
5/41 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
19.5%
8/41 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
11.9%
5/42 • Number of events 15
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
22.0%
9/41 • Number of events 25
All randomized participants who received at least one dose of study drug.
|
14.3%
6/42 • Number of events 17
All randomized participants who received at least one dose of study drug.
|
19.5%
8/41 • Number of events 45
All randomized participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
4.9%
2/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 16
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
43.9%
18/41 • Number of events 60
All randomized participants who received at least one dose of study drug.
|
40.5%
17/42 • Number of events 75
All randomized participants who received at least one dose of study drug.
|
51.2%
21/41 • Number of events 103
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.2%
5/41 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
14.6%
6/41 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
17.1%
7/41 • Number of events 15
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 23
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.3%
3/41 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
12.2%
5/41 • Number of events 13
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.3%
3/41 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
19.5%
8/41 • Number of events 19
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.3%
3/41 • Number of events 15
All randomized participants who received at least one dose of study drug.
|
11.9%
5/42 • Number of events 13
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
3/41 • Number of events 18
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 17
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.5%
8/41 • Number of events 25
All randomized participants who received at least one dose of study drug.
|
19.0%
8/42 • Number of events 35
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.3%
3/41 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.3%
3/41 • Number of events 23
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.4%
1/41 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 16
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.3%
3/41 • Number of events 24
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.3%
3/41 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 18
All randomized participants who received at least one dose of study drug.
|
12.2%
5/41 • Number of events 25
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
19.5%
8/41 • Number of events 26
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 15
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
14.6%
6/41 • Number of events 27
All randomized participants who received at least one dose of study drug.
|
19.0%
8/42 • Number of events 36
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 21
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
14.6%
6/41 • Number of events 23
All randomized participants who received at least one dose of study drug.
|
11.9%
5/42 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
22.0%
9/41 • Number of events 47
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
14.6%
6/41 • Number of events 22
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 15
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
9.8%
4/41 • Number of events 29
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 15
All randomized participants who received at least one dose of study drug.
|
12.2%
5/41 • Number of events 19
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.3%
3/41 • Number of events 17
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 20
All randomized participants who received at least one dose of study drug.
|
12.2%
5/41 • Number of events 41
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
9.8%
4/41 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
9.5%
4/42 • Number of events 28
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
9.8%
4/41 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
9.8%
4/41 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
11.9%
5/42 • Number of events 33
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 21
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
14.6%
6/41 • Number of events 38
All randomized participants who received at least one dose of study drug.
|
9.5%
4/42 • Number of events 20
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/16
All randomized participants who received at least one dose of study drug.
|
0.00%
0/13
All randomized participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.1%
7/41 • Number of events 26
All randomized participants who received at least one dose of study drug.
|
16.7%
7/42 • Number of events 19
All randomized participants who received at least one dose of study drug.
|
14.6%
6/41 • Number of events 21
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.9%
2/41 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 13
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
34.1%
14/41 • Number of events 38
All randomized participants who received at least one dose of study drug.
|
23.8%
10/42 • Number of events 43
All randomized participants who received at least one dose of study drug.
|
17.1%
7/41 • Number of events 33
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.9%
2/41 • Number of events 15
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.9%
2/41 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.3%
3/41 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.9%
2/41 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 19
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.6%
6/41 • Number of events 23
All randomized participants who received at least one dose of study drug.
|
14.3%
6/42 • Number of events 42
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 35
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
4.9%
2/41 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.8%
4/41 • Number of events 17
All randomized participants who received at least one dose of study drug.
|
9.5%
4/42 • Number of events 34
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 24
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.2%
5/41 • Number of events 13
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.6%
6/41 • Number of events 18
All randomized participants who received at least one dose of study drug.
|
14.3%
6/42 • Number of events 13
All randomized participants who received at least one dose of study drug.
|
14.6%
6/41 • Number of events 24
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.4%
1/41 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
4.9%
2/41 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 15
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
7.3%
3/41 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
2.4%
1/41 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
9.5%
4/42 • Number of events 22
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
9.8%
4/41 • Number of events 13
All randomized participants who received at least one dose of study drug.
|
11.9%
5/42 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
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