Trial Outcomes & Findings for A Study in Participants With Acute Leukemia (NCT NCT01214603)
NCT ID: NCT01214603
Last Updated: 2018-11-19
Results Overview
Drug-related events were defined as treatment-emergent serious and other non-serious AEs that were considered by the investigator to be related to study drug. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline through study completion [Cycle 9 plus 30 days post last dose (21-day or 28 day cycles)]
Results posted on
2018-11-19
Participant Flow
Study had safety lead-in phase \[40 milligrams (mg) LY2090314 administered using 3 treatment schedules\]. Each cohort of participants had different schedule. Safety lead-in data determined if expansion phase opened to enrollment. No participant enrolled in expansion phase. Participants who completed 2 cycles of treatment considered study completers.
Participant milestones
| Measure |
Cohort 1, 40 mg LY2090314: D1, D8, D15
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on Day (D)1, D8, and D15 for two 28-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 2, 40 mg LY2090314: D1, D5, D9
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 3, 40 mg LY2090314: D1, D5, D9, D12
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
7
|
|
Overall Study
Received at Least 1 Dose of LY2090314
|
7
|
6
|
7
|
|
Overall Study
COMPLETED
|
2
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1, 40 mg LY2090314: D1, D8, D15
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on Day (D)1, D8, and D15 for two 28-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 2, 40 mg LY2090314: D1, D5, D9
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 3, 40 mg LY2090314: D1, D5, D9, D12
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Progressive Disease
|
4
|
1
|
3
|
Baseline Characteristics
A Study in Participants With Acute Leukemia
Baseline characteristics by cohort
| Measure |
Cohort 1, 40 mg LY2090314: D1, D8, D15
n=7 Participants
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 2, 40 mg LY2090314: D1, D5, D9
n=6 Participants
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 3, 40 mg LY2090314: D1, D5, D9, D12
n=7 Participants
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
75.3 years
STANDARD_DEVIATION 7.16 • n=39 Participants
|
61.7 years
STANDARD_DEVIATION 14.98 • n=41 Participants
|
67.6 years
STANDARD_DEVIATION 9.81 • n=35 Participants
|
68.5 years
STANDARD_DEVIATION 11.73 • n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
20 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
18 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
20 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline through study completion [Cycle 9 plus 30 days post last dose (21-day or 28 day cycles)]Population: Participants who received at least 1 dose of study drug.
Drug-related events were defined as treatment-emergent serious and other non-serious AEs that were considered by the investigator to be related to study drug. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Cohort 1, 40 mg LY2090314: D1, D8, D15
n=7 Participants
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 2, 40 mg LY2090314: D1, D5, D9
n=6 Participants
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 3, 40 mg LY2090314: D1, D5, D9, D12
n=7 Participants
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
|---|---|---|---|
|
Number of Participants With 1 or More Study Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
Study Drug-Related SAE(s)
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With 1 or More Study Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
Study Drug-Related AE(s)
|
6 Participants
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline to progressive disease (up to Cycle 9, 21-day or 28 day cycles)Population: Participants who received at least 1 dose of study drug.
The Revised International Working Group criteria were used to determine the response for participants with acute myelogenous leukemia (AML). Complete response, also known as complete remission (CR) included the following categories: Morphologic CR defined as \<5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells, along with peripheral blood levels including platelets ≥100\*10\^9/Liter (L) and absolute neutrophil count (ANC) ≥1\*10\^9/L, Morphologic CR with incomplete blood count recovery (CRi), Cytogenetic CR, and Molecular CR. Partial response, also known as partial remission (PR) was defined as a decrease of at least 50% in blast count on the bone marrow aspirate. PR required all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate.
Outcome measures
| Measure |
Cohort 1, 40 mg LY2090314: D1, D8, D15
n=7 Participants
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 2, 40 mg LY2090314: D1, D5, D9
n=6 Participants
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 3, 40 mg LY2090314: D1, D5, D9, D12
n=7 Participants
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
|---|---|---|---|
|
Number of Participants With Best Response of Complete Response or Partial Response
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Best Response of Complete Response or Partial Response
PR
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to progressive disease (up to Cycle 9, 21-day or 28 day cycles)Population: Participants who received at least 1 dose of study drug.
The Revised International Working Group criteria were used to determine the response for participants with AML. Complete response, also known as complete remission (CR) included the following categories: Morphologic CR defined as \<5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells, along with peripheral blood levels including platelets ≥100\*10\^9/L and ANC ≥1\*10\^9/L, Morphologic CR with incomplete blood count recovery (CRi), Cytogenetic CR, and Molecular CR. Partial response, also known as partial remission (PR) was defined as a decrease of at least 50% in blast count on the bone marrow aspirate. PR required all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate. Percentage of participants=\[(number of participants with CR or PR)/(number of participants treated)\]\*100.
Outcome measures
| Measure |
Cohort 1, 40 mg LY2090314: D1, D8, D15
n=7 Participants
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 2, 40 mg LY2090314: D1, D5, D9
n=6 Participants
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 3, 40 mg LY2090314: D1, D5, D9, D12
n=7 Participants
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
|---|---|---|---|
|
Percentage of Participants With Best Response of Complete Response or Partial Response
CR
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Best Response of Complete Response or Partial Response
PR
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1: D1 and/or D9 and/or D15 [predose, 30 minutes (during infusion), up to 24 h after infusion started (1 h, 2 h, 4 h, 6 h, 8 h, and 24 h)]Population: Participants who received at least 1 dose of study drug and had sufficient postdose samples collected to allow estimation of the PK parameters using noncompartmental methods of analysis.
AUC(0-8) was estimated from the plasma drug concentration time profile.
Outcome measures
| Measure |
Cohort 1, 40 mg LY2090314: D1, D8, D15
n=14 Profiles
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 2, 40 mg LY2090314: D1, D5, D9
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 3, 40 mg LY2090314: D1, D5, D9, D12
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to 8 Hours (h) Postdose [AUC(0-8)]
|
898 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 47
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: D1 and/or D9 and/or D15 [predose, 30 minutes (during infusion), up to 24 h after infusion started (1 h, 2 h, 4 h, 6 h, 8 h, and 24 h)]Population: Participants who received at least 1 dose of study drug and had sufficient postdose samples collected to allow estimation of the PK parameters using noncompartmental methods of analysis.
AUC(0-inf) was estimated from the plasma drug concentration time profile.
Outcome measures
| Measure |
Cohort 1, 40 mg LY2090314: D1, D8, D15
n=3 Profiles
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 2, 40 mg LY2090314: D1, D5, D9
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 3, 40 mg LY2090314: D1, D5, D9, D12
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
|---|---|---|---|
|
PK: AUC From Time 0 to Infinity [AUC(0-inf)]
|
963 ng*h/mL
Geometric Coefficient of Variation 46.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: D1 and/or D9 and/or D15 [predose, 30 minutes (during infusion), up to 24 h after infusion started (1 h, 2 h, 4 h, 6 h, 8 h, and 24 h)]Population: Participants who received at least 1 dose of study drug and had sufficient postdose samples collected to allow estimation of the PK parameters using noncompartmental methods of analysis.
Cmax is the maximum observed concentration estimated from the plasma drug concentration time profile.
Outcome measures
| Measure |
Cohort 1, 40 mg LY2090314: D1, D8, D15
n=36 Profiles
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 2, 40 mg LY2090314: D1, D5, D9
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 3, 40 mg LY2090314: D1, D5, D9, D12
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
|---|---|---|---|
|
PK: Maximum Concentration (Cmax)
|
476 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 56.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: D1 and D9 (predose, 1 h, 2 h, 4 h, 8 h, and 24 h after infusion started); Cycle 1: D5, D8, and D12 and C2 through C9: D1 (predose, 2 h after infusion started); Cycle 1: D15 (predose, 1 h, 2 h, 4 h, and 8 h after infusion started)Population: Participants who received at least 1 dose of study drug and had a predose and at least 1 postdose β-catenin sample collected.
Percent change=\[(β-catenin level postdose-predose level)/(predose β-catenin levels)\]\*100. Participants in Cohort 1 had β-catenin samples collected on Cycle 1: D1, D8, and D15, and Cycles 2 through 9: D1. Participants in Cohort 2 had β-catenin samples collected on Cycle 1: D1, D5, and D9 and Cycles 2 through 9: D1. Participants in Cohort 3 had β-catenin samples collected on Cycle 1: D1, D5, D9, and D12 and Cycles 2 through 9: D1.
Outcome measures
| Measure |
Cohort 1, 40 mg LY2090314: D1, D8, D15
n=18 Participants
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 2, 40 mg LY2090314: D1, D5, D9
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 3, 40 mg LY2090314: D1, D5, D9, D12
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
|---|---|---|---|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 4, Day 1, 2 h postdose
|
408.5 percent change
Standard Deviation 291.78
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 5, Day 1, 2 h postdose
|
186.3 percent change
Standard Deviation 188.34
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 9, Day 1, 2 h postdose
|
83.1 percent change
Standard Deviation NA
Only 1 participant included in the analysis, therefore standard deviation is not calculable.
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 1, Day 1, 1 h postdose
|
557.4 percent change
Standard Deviation 397.49
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 1, Day 1, 2 h postdose
|
513.7 percent change
Standard Deviation 284.19
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 1, Day 1, 4 h postdose
|
547.6 percent change
Standard Deviation 342.89
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 1, Day 1, 8 h postdose
|
285.7 percent change
Standard Deviation 421.91
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 1, Day 1, 24 h postdose
|
83.6 percent change
Standard Deviation 141.96
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 1, Day 5, 2 h postdose
|
817.2 percent change
Standard Deviation 576.25
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 1, Day 8, 2 h postdose
|
343.2 percent change
Standard Deviation 216.26
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 1, Day 9, 1 h postdose
|
736.1 percent change
Standard Deviation 831.56
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 1, Day 9, 2 h postdose
|
746.5 percent change
Standard Deviation 728.22
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 1, Day 9, 4 h postdose
|
684.3 percent change
Standard Deviation 630.99
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 1, Day 9, 8 h postdose
|
141.2 percent change
Standard Deviation 133.13
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 1, Day 9, 24 h postdose
|
9.1 percent change
Standard Deviation 99.14
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 1, Day 12, 2 h postdose
|
837.8 percent change
Standard Deviation 496.95
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 1, Day 15, 1 h postdose
|
362.3 percent change
Standard Deviation 246.81
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 1, Day 15, 2 h postdose
|
470.6 percent change
Standard Deviation 296.31
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 1, Day 15, 4 h postdose
|
575.5 percent change
Standard Deviation 422.33
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 1, Day 15, 8 h postdose
|
474.2 percent change
Standard Deviation 499.30
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 2, Day 1, 2 h postdose
|
429.1 percent change
Standard Deviation 339.86
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 3, Day 1, 2 h postdose
|
348.5 percent change
Standard Deviation 458.67
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 6, Day 1, 2 h postdose
|
80.0 percent change
Standard Deviation 77.57
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 7, Day 1, 2 h postdose
|
151.3 percent change
Standard Deviation 155.60
|
—
|
—
|
|
Percent Change From Predose Beta (β)-Catenin Levels
Cycle 8, Day 1, 2 h postdose
|
418.6 percent change
Standard Deviation 357.18
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through study completion [Cycle 9 plus 30 days post last dose (21-day or 28 day cycles)]Population: Participants who received at least 1 dose of study drug.
The number of participants who died while on study treatment and the number of participants who died during the 30-day follow-up (30 days post last dose) are reported.
Outcome measures
| Measure |
Cohort 1, 40 mg LY2090314: D1, D8, D15
n=7 Participants
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 2, 40 mg LY2090314: D1, D5, D9
n=6 Participants
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 3, 40 mg LY2090314: D1, D5, D9, D12
n=7 Participants
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
|---|---|---|---|
|
Number of Participants Who Died
Death During 30-Day Follow-Up
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Died
Death On Study, Prior To Cycle 2 Completion
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Died
Death On Study, Post Cycle 2 Completion
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Cohort 1, 40 mg LY2090314: D1, D8, D15
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2, 40 mg LY2090314: D1, D5, D9
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 3, 40 mg LY2090314: D1, D5, D9, D12
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1, 40 mg LY2090314: D1, D8, D15
n=7 participants at risk
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 2, 40 mg LY2090314: D1, D5, D9
n=6 participants at risk
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 3, 40 mg LY2090314: D1, D5, D9, D12
n=7 participants at risk
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
28.6%
2/7 • Number of events 3
|
|
Blood and lymphatic system disorders
Splenic infarction
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Cardiac disorders
Cardiac ventricular disorder
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Ileitis
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Clostridial infection
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
0.00%
0/7
|
|
Infections and infestations
Lung infection
|
0.00%
0/7
|
0.00%
0/6
|
28.6%
2/7 • Number of events 2
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Haemorrhagic stroke
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Nervous system disorders
Syncope
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Vascular disorders
Hypertension
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
Other adverse events
| Measure |
Cohort 1, 40 mg LY2090314: D1, D8, D15
n=7 participants at risk
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 2, 40 mg LY2090314: D1, D5, D9
n=6 participants at risk
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
Cohort 3, 40 mg LY2090314: D1, D5, D9, D12
n=7 participants at risk
LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.
If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.6%
2/7 • Number of events 2
|
0.00%
0/6
|
0.00%
0/7
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Eye disorders
Cataract
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Eye disorders
Eye disorder
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Eye disorders
Halo vision
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Eye disorders
Retinal exudates
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Eye disorders
Vision blurred
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
2/7 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Dry mouth
|
28.6%
2/7 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
1/7 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Gingival blister
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
42.9%
3/7 • Number of events 4
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Asthenia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
General disorders
Catheter site pain
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.00%
0/7
|
33.3%
2/6 • Number of events 3
|
0.00%
0/7
|
|
General disorders
Chest pain
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
General disorders
Chills
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Cyst
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
General disorders
Fatigue
|
42.9%
3/7 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Influenza like illness
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Malaise
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
General disorders
Mucosal inflammation
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Nodule
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Oedema peripheral
|
14.3%
1/7 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Pyrexia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Paronychia
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Rhinitis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
0.00%
0/7
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
28.6%
2/7 • Number of events 3
|
|
Investigations
International normalised ratio increased
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Platelet count decreased
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Weight decreased
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Decreased appetite
|
57.1%
4/7 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
28.6%
2/7 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
28.6%
2/7 • Number of events 2
|
50.0%
3/6 • Number of events 4
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/7
|
33.3%
2/6 • Number of events 3
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Psychiatric disorders
Depression
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Renal and urinary disorders
Renal failure
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/5
|
33.3%
1/3 • Number of events 1
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
28.6%
2/7 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
28.6%
2/7 • Number of events 2
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7
|
50.0%
3/6 • Number of events 3
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7
|
16.7%
1/6 • Number of events 2
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/7
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/7
|
33.3%
2/6 • Number of events 3
|
0.00%
0/7
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Vascular disorders
Embolism
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
|
Vascular disorders
Haematoma
|
28.6%
2/7 • Number of events 2
|
0.00%
0/6
|
0.00%
0/7
|
|
Vascular disorders
Hypotension
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60