Trial Outcomes & Findings for A Phase 1 Study of LY2787106 in Cancer and Anemia (NCT NCT01340976)
NCT ID: NCT01340976
Last Updated: 2018-10-03
Results Overview
Number of participants with one or more treatment emergent adverse event (TEAE) or any Serious AE (SAE). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
Baseline to Study Completion (up to 5 Years)
Results posted on
2018-10-03
Participant Flow
Part B participants who received 8 weekly doses and discontinued treatment were considered completers.
Participant milestones
| Measure |
Part A 0.3 Milligram Per Kilogram (mg/kg) LY2787106
Part A: Participants received 0.3 mg/kg, LY2787106 intravenously (IV), day 1 of up to three 21-day cycles.
|
Part A 1.0 mg/kg LY2787106
Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 3.0 mg/kg LY2787106
Part A: Participants received 3.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 10.0 mg/kg LY2787106
Part A: Participants received 10.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part B 10.0 mg/kg LY2787106
Part B: Participants received 10.0 mg/kg LY2787106, IV, on day 1 of up to eight 7-day cycles.
|
Part B 10.0 mg/kg LY2787106+Iron
Part B: Participants received 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
7
|
5
|
7
|
7
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
4
|
3
|
7
|
5
|
7
|
7
|
|
Overall Study
COMPLETED
|
0
|
1
|
4
|
2
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
3
|
3
|
2
|
1
|
Reasons for withdrawal
| Measure |
Part A 0.3 Milligram Per Kilogram (mg/kg) LY2787106
Part A: Participants received 0.3 mg/kg, LY2787106 intravenously (IV), day 1 of up to three 21-day cycles.
|
Part A 1.0 mg/kg LY2787106
Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 3.0 mg/kg LY2787106
Part A: Participants received 3.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 10.0 mg/kg LY2787106
Part A: Participants received 10.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part B 10.0 mg/kg LY2787106
Part B: Participants received 10.0 mg/kg LY2787106, IV, on day 1 of up to eight 7-day cycles.
|
Part B 10.0 mg/kg LY2787106+Iron
Part B: Participants received 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.
|
|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
1
|
1
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Dose Limiting Toxicity Stopping Rule
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Other anemia treatment
|
1
|
0
|
2
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 1 Study of LY2787106 in Cancer and Anemia
Baseline characteristics by cohort
| Measure |
Part A 0.3 mg/kg LY2787106
n=4 Participants
Part A: Participants received 0.3 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 1.0 mg/kg LY2787106
n=3 Participants
Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 3.0 mg/kg LY2787106
n=7 Participants
Part A: Participants received 3.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 10.0 mg/kg LY2787106
n=5 Participants
Part A: Participants received 10.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part B 10.0 mg/kg LY2787106
n=7 Participants
Part B: Participants received 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles.
|
Part B 10.0 mg/kg LY2787106+Iron
n=7 Participants
Part B: Participants received 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
76.7 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 7.9 • n=4 Participants
|
66.3 years
STANDARD_DEVIATION 9.2 • n=21 Participants
|
62.7 years
STANDARD_DEVIATION 7.5 • n=8 Participants
|
64.9 years
STANDARD_DEVIATION 10.0 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
25 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
5 participants
n=4 Participants
|
7 participants
n=21 Participants
|
7 participants
n=8 Participants
|
33 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline to Study Completion (up to 5 Years)Population: All participants who received at least 1 dose of study drug.
Number of participants with one or more treatment emergent adverse event (TEAE) or any Serious AE (SAE). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Outcome measures
| Measure |
Part A 0.3 mg/kg LY2787106
n=4 Participants
Part A: Participants received 0.3 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 1.0 mg/kg LY2787106
n=3 Participants
Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 3.0 mg/kg LY2787106
n=7 Participants
Part A: Participants received 3.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 10.0 mg/kg LY2787106
n=5 Participants
Part A: Participants received 10.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part B 10 mg/kg LY2787106
n=7 Participants
Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles.
|
Part B 10 mg/kg LY2787106+Iron
n=7 Participants
Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Events
Participants with at least 1 TEAE event
|
4 participants
|
3 participants
|
6 participants
|
5 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Events
Participants with at least 1 SAE event
|
1 participants
|
2 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline, Cycle 4 (7-day cycle)Population: Evaluable population in Part B is defined as a participant who received all 4 of the first 4 per-cycle doses of study medication, maintained at least 60% compliance with oral iron therapy during the first 4 cycles of LY2787106 (if enrolled to the oral iron cohort), and who had a hemoglobin assessment after each of the first 4 doses.
This analysis assesses the mean change in Hemoglobin from baseline to the end of Cycle 4. The analysis was carried separately for Cohort B1 without supplemental iron and Cohort B2 with supplemental iron.
Outcome measures
| Measure |
Part A 0.3 mg/kg LY2787106
n=6 Participants
Part A: Participants received 0.3 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 1.0 mg/kg LY2787106
n=6 Participants
Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 3.0 mg/kg LY2787106
Part A: Participants received 3.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 10.0 mg/kg LY2787106
Part A: Participants received 10.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part B 10 mg/kg LY2787106
Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles.
|
Part B 10 mg/kg LY2787106+Iron
Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Hemoglobin With or Without Oral Iron Supplementation
|
-0.5 grams per deciliter (g/dL)
Standard Deviation 0.49
|
-0.2 grams per deciliter (g/dL)
Standard Deviation 0.80
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 2, and 4 of Cycles 1 and 5, Day 1 of Cycles 2, 3, 4, 6, 7 and 8 (Part A 21-day cycles, Part B 7-day cycles) and 1, 3, and 9 weeks after the last infusionPopulation: All participants who received at least 1 dose of study drug and who had evaluable PK data for Cmax.
Cmax is the maximum serum concentration after a single IV dose of the study drug.
Outcome measures
| Measure |
Part A 0.3 mg/kg LY2787106
n=4 Participants
Part A: Participants received 0.3 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 1.0 mg/kg LY2787106
n=3 Participants
Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 3.0 mg/kg LY2787106
n=7 Participants
Part A: Participants received 3.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 10.0 mg/kg LY2787106
n=5 Participants
Part A: Participants received 10.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part B 10 mg/kg LY2787106
n=5 Participants
Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles.
|
Part B 10 mg/kg LY2787106+Iron
n=6 Participants
Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax)
|
5450 nanogram per milliliter (ng/ml)
Standard Deviation 24
|
22300 nanogram per milliliter (ng/ml)
Standard Deviation 27
|
79000 nanogram per milliliter (ng/ml)
Standard Deviation 15
|
205000 nanogram per milliliter (ng/ml)
Standard Deviation 12
|
258000 nanogram per milliliter (ng/ml)
Standard Deviation 15
|
199000 nanogram per milliliter (ng/ml)
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Days 1, 2, and 4 of Cycles 1 and 5, Day 1 of Cycles 2, 3, 4, 6, 7 and 8 (Part A 21-day cycles, Part B 7-day cycles) and 1, 3, and 9 weeks after the last infusionPopulation: All participants who received at least 1 dose of study drug and who had evaluable PK data for AUC\[0-∞\]).
AUC is the area under the concentration versus time curve from time zero to infinity.
Outcome measures
| Measure |
Part A 0.3 mg/kg LY2787106
n=4 Participants
Part A: Participants received 0.3 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 1.0 mg/kg LY2787106
n=3 Participants
Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 3.0 mg/kg LY2787106
n=7 Participants
Part A: Participants received 3.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 10.0 mg/kg LY2787106
n=5 Participants
Part A: Participants received 10.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part B 10 mg/kg LY2787106
n=6 Participants
Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles.
|
Part B 10 mg/kg LY2787106+Iron
n=5 Participants
Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.
|
|---|---|---|---|---|---|---|
|
PK: Area Under the Curve (AUC[0-∞])
|
663 micrograms∙hour per milliliter (µg∙h/mL)
Standard Deviation 42
|
2146 micrograms∙hour per milliliter (µg∙h/mL)
Standard Deviation 64
|
8934 micrograms∙hour per milliliter (µg∙h/mL)
Standard Deviation 39
|
24503 micrograms∙hour per milliliter (µg∙h/mL)
Standard Deviation 19
|
21000 micrograms∙hour per milliliter (µg∙h/mL)
Standard Deviation 19
|
16798 micrograms∙hour per milliliter (µg∙h/mL)
Standard Deviation 27
|
SECONDARY outcome
Timeframe: Baseline to Cycle 1 of Part APopulation: MTD was not determined in this study, so zero participants were analyzed.
MTD is defined as being the highest tested dose below the level at which one-third or more of participants experience a Dose-limiting toxicity (DLT). DLT is defined as an adverse event occurring in any part of the study that is related to the study medication, occurs during Cycle 1 of Part A, and fulfills any one of the following criteria: 1. Clinically significant Grade 2 toxicity, such as angina, arrhythmia, seizure, dyspnea, rash with significant blistering or desquamation, or other event deemed significant by either the investigator. 2. ≥Grade 3 anemia (excluding participants with baseline \<9.0 g/dL) or hemoglobin (Hb) decrease \>1.0 g/dL if baseline Hb \<9.0 g/dL, confirmed by 2 independent measurements. 3. ≥ Grade 3 cytokine release syndrome/acute infusion reaction. 4. Other ≥ Grade 3 hematological or non-hematological toxicity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Cycle 4 (7-day cycle)Population: Evaluable Population in Part B is defined as a participant who has received all 4 of the first 4 per-cycle doses of study dose, maintained at least 60% compliance with oral iron therapy during the first 4 cycles of LY2787106 (if enrolled to the oral iron cohort), and who has had a hemoglobin assessment after each of the first 4 doses.
Mean change in serum iron from baseline to the end of Cycle 4.
Outcome measures
| Measure |
Part A 0.3 mg/kg LY2787106
n=6 Participants
Part A: Participants received 0.3 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 1.0 mg/kg LY2787106
n=6 Participants
Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 3.0 mg/kg LY2787106
Part A: Participants received 3.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 10.0 mg/kg LY2787106
Part A: Participants received 10.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part B 10 mg/kg LY2787106
Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles.
|
Part B 10 mg/kg LY2787106+Iron
Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Serum Iron
|
-0.4 micromole per liter (umol/L)
Standard Deviation 6.17
|
-4.6 micromole per liter (umol/L)
Standard Deviation 9.20
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle 4 (7-day cycle)Population: Evaluable Population in Part B is defined as a participant who has received all 4 of the first 4 per-cycle doses of study dose, maintained at least 60% compliance with oral iron therapy during the first 4 cycles of LY2787106 (if enrolled to the oral iron cohort), and who has had a hemoglobin assessment after each of the first 4 doses.
Mean change in reticulocyte count from baseline to the end of Cycle 4.
Outcome measures
| Measure |
Part A 0.3 mg/kg LY2787106
n=4 Participants
Part A: Participants received 0.3 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 1.0 mg/kg LY2787106
n=6 Participants
Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 3.0 mg/kg LY2787106
Part A: Participants received 3.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 10.0 mg/kg LY2787106
Part A: Participants received 10.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part B 10 mg/kg LY2787106
Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles.
|
Part B 10 mg/kg LY2787106+Iron
Part B: Participants received 10 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Reticulocyte Count
|
1.2 percentage of reticulytes
Standard Deviation 0.68
|
0.0 percentage of reticulytes
Standard Deviation 0.46
|
—
|
—
|
—
|
—
|
Adverse Events
Part A 0.3 mg/kg LY2787106
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A 1.0 mg/kg LY2787106
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A 3.0 mg/kg LY2787106
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A 10.0 mg/kg LY2787106
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B 10.0 mg/kg LY2787106
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part B 10.0 mg/kg LY2787106+Iron
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A 0.3 mg/kg LY2787106
n=4 participants at risk
Part A: Participants received 0.3 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 1.0 mg/kg LY2787106
n=3 participants at risk
Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 3.0 mg/kg LY2787106
n=7 participants at risk
Part A: Participants received 3.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 10.0 mg/kg LY2787106
n=5 participants at risk
Part A: Participants received 10.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part B 10.0 mg/kg LY2787106
n=7 participants at risk
Part B: Participants received 10.0 mg/kg of LY2787106, administered IV, on day 1 of up to eight 7-day cycles.
|
Part B 10.0 mg/kg LY2787106+Iron
n=7 participants at risk
Part B: 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
Other adverse events
| Measure |
Part A 0.3 mg/kg LY2787106
n=4 participants at risk
Part A: Participants received 0.3 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 1.0 mg/kg LY2787106
n=3 participants at risk
Part A: Participants received 1.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 3.0 mg/kg LY2787106
n=7 participants at risk
Part A: Participants received 3.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part A 10.0 mg/kg LY2787106
n=5 participants at risk
Part A: Participants received 10.0 mg/kg, LY2787106, IV, day 1 of up to three 21-day cycles.
|
Part B 10.0 mg/kg LY2787106
n=7 participants at risk
Part B: Participants received 10.0 mg/kg of LY2787106, administered IV, on day 1 of up to eight 7-day cycles.
|
Part B 10.0 mg/kg LY2787106+Iron
n=7 participants at risk
Part B: 10.0 mg/kg, LY2787106, IV, on day 1 of up to eight 7-day cycles with daily oral iron supplementation.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
28.6%
2/7 • Number of events 2
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
0.00%
0/7
|
20.0%
1/5 • Number of events 2
|
0.00%
0/7
|
14.3%
1/7 • Number of events 2
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Eye disorders
Eye irritation
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 2
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 2
|
28.6%
2/7 • Number of events 5
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
28.6%
2/7 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
28.6%
2/7 • Number of events 2
|
0.00%
0/7
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
28.6%
2/7 • Number of events 4
|
14.3%
1/7 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
28.6%
2/7 • Number of events 7
|
42.9%
3/7 • Number of events 8
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4
|
0.00%
0/3
|
14.3%
1/7 • Number of events 2
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/4
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Gingival recession
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 3
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
28.6%
2/7 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
42.9%
3/7 • Number of events 10
|
57.1%
4/7 • Number of events 6
|
|
Gastrointestinal disorders
Retching
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
28.6%
2/7 • Number of events 3
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Chills
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 11
|
42.9%
3/7 • Number of events 3
|
|
General disorders
Fatigue
|
0.00%
0/4
|
33.3%
1/3 • Number of events 4
|
28.6%
2/7 • Number of events 4
|
0.00%
0/5
|
71.4%
5/7 • Number of events 25
|
100.0%
7/7 • Number of events 35
|
|
General disorders
Gait disturbance
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Influenza like illness
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Local swelling
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
|
General disorders
Mucosal inflammation
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Oedema
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
42.9%
3/7 • Number of events 5
|
14.3%
1/7 • Number of events 2
|
|
General disorders
Peripheral swelling
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Pyrexia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
28.6%
2/7 • Number of events 4
|
0.00%
0/7
|
|
General disorders
Temperature intolerance
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
28.6%
2/7 • Number of events 5
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Folliculitis
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
28.6%
2/7 • Number of events 2
|
0.00%
0/7
|
|
Infections and infestations
Genital abscess
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/4
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
|
Infections and infestations
Lung infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
40.0%
2/5 • Number of events 3
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Blood albumin decreased
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Blood folate decreased
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Blood potassium increased
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Blood urea increased
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
28.6%
2/7 • Number of events 2
|
0.00%
0/7
|
|
Investigations
Haematocrit decreased
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Heart rate increased
|
0.00%
0/4
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 3
|
|
Investigations
Platelet count decreased
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
28.6%
2/7 • Number of events 2
|
0.00%
0/7
|
|
Investigations
Weight decreased
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
28.6%
2/7 • Number of events 2
|
|
Investigations
Weight increased
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
28.6%
2/7 • Number of events 3
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • Number of events 2
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
28.6%
2/7 • Number of events 6
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
28.6%
2/7 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
28.6%
2/7 • Number of events 3
|
28.6%
2/7 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4
|
0.00%
0/3
|
14.3%
1/7 • Number of events 2
|
0.00%
0/5
|
28.6%
2/7 • Number of events 2
|
28.6%
2/7 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 34
|
14.3%
1/7 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
28.6%
2/7 • Number of events 2
|
42.9%
3/7 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/7
|
28.6%
2/7 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4
|
0.00%
0/3
|
14.3%
1/7 • Number of events 2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 18
|
28.6%
2/7 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
42.9%
3/7 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4
|
0.00%
0/3
|
28.6%
2/7 • Number of events 2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 2
|
|
Nervous system disorders
Headache
|
0.00%
0/4
|
0.00%
0/3
|
28.6%
2/7 • Number of events 2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 18
|
42.9%
3/7 • Number of events 4
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 6
|
0.00%
0/7
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 7
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/2
|
0.00%
0/1
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
28.6%
2/7 • Number of events 3
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
42.9%
3/7 • Number of events 3
|
71.4%
5/7 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 3
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
14.3%
1/7 • Number of events 2
|
14.3%
1/7 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/7
|
28.6%
2/7 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
28.6%
2/7 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Vascular disorders
Hot flush
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/5
|
14.3%
1/7 • Number of events 4
|
14.3%
1/7 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.00%
0/4
|
0.00%
0/3
|
14.3%
1/7 • Number of events 2
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
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