Trial Outcomes & Findings for A Dose-Escalation Study for Patients With Advanced Cancer (NCT NCT01214642)
NCT ID: NCT01214642
Last Updated: 2018-08-06
Results Overview
The recommended dose and schedule for Phase 2 studies is defined as the maximum tolerated dose (MTD). MTD is defined as the dose level at which no more than 2 dose limiting toxicities (DLTs), no more than 3 dose reductions (DR) or dose omissions (DO) and no more than 1 DLT plus 2 DR/DO occurred. DLT is defined as an adverse event (AE) occurring in Cycle 1 with the following criteria according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0: Any ≥Grade 3 nonhematological toxicity (except nausea/vomiting or diarrhea controlled with treatment or fatigue); ≥Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia with bleeding; Grade 4 hematological toxicity of \>5 days duration, excluding thrombocytopenia; febrile neutropenia.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
63 participants
Primary outcome timeframe
Cycle 1 (21 days): Day 1, 5 and 9, any AE reported
Results posted on
2018-08-06
Participant Flow
Part A is the LY2523355 dose escalation phase and Part B is the LY2523355 dose confirmation phase. 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 received at 2 cycles of treatment.
Participant milestones
| Measure |
Part A - Days 1, 5, 9 - 2 mg/m^2/Day
2 milligrams per meter squared per day (mg/m\^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 4 mg/m^2/Day
4 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 8 mg/m^2/Day
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 7 mg/m^2/Day
7 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 6 mg/m^2/Day
6 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 5 mg/m^2/Day
5 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 8 - 8 mg/m^2/Day
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
|
Part A - Days 1, 5+PEG - 8 mg/m^2/Day
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
|
Part A and B- Days 1, 5+PEG - 12 mg/m^2/Day
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 16 mg/m^2/Day
16 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 14 mg/m^2/Day
14 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 4+PEG - 12 mg/m^2/Day
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
6
|
6
|
3
|
6
|
3
|
13
|
4
|
4
|
6
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
3
|
3
|
6
|
6
|
6
|
3
|
6
|
3
|
13
|
4
|
4
|
6
|
|
Overall Study
Complete at Least 2 Cycles of Study Drug
|
3
|
1
|
5
|
4
|
6
|
1
|
6
|
3
|
12
|
2
|
2
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
6
|
6
|
6
|
3
|
6
|
3
|
13
|
4
|
4
|
6
|
Reasons for withdrawal
| Measure |
Part A - Days 1, 5, 9 - 2 mg/m^2/Day
2 milligrams per meter squared per day (mg/m\^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 4 mg/m^2/Day
4 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 8 mg/m^2/Day
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 7 mg/m^2/Day
7 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 6 mg/m^2/Day
6 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 5 mg/m^2/Day
5 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 8 - 8 mg/m^2/Day
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
|
Part A - Days 1, 5+PEG - 8 mg/m^2/Day
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
|
Part A and B- Days 1, 5+PEG - 12 mg/m^2/Day
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 16 mg/m^2/Day
16 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 14 mg/m^2/Day
14 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 4+PEG - 12 mg/m^2/Day
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
3
|
2
|
3
|
5
|
5
|
3
|
5
|
3
|
10
|
2
|
1
|
4
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
A Dose-Escalation Study for Patients With Advanced Cancer
Baseline characteristics by cohort
| Measure |
Part A - Days 1, 5, 9 - 2 mg/m^2/Day
n=3 Participants
2 milligrams per meter squared per day (mg/m\^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 4 mg/m^2/Day
n=3 Participants
4 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 8 mg/m^2/Day
n=6 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 7 mg/m^2/Day
n=6 Participants
7 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 6 mg/m^2/Day
n=6 Participants
6 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 5 mg/m^2/Day
n=3 Participants
5 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 8 - 8 mg/m^2/Day
n=6 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
|
Part A - Days 1, 5+PEG - 8 mg/m^2/Day
n=3 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
|
Part A and B - Days 1, 5+PEG - 12 mg/m^2/Day
n=13 Participants
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6 in Part A and Part B.
|
Part A - Days 1, 5+PEG - 16 mg/m^2/Day
n=4 Participants
16 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 14 mg/m^2/Day
n=4 Participants
14 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 4+PEG - 12 mg/m^2/Day
n=6 Participants
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.60 years
STANDARD_DEVIATION 5.484 • n=5 Participants
|
48.07 years
STANDARD_DEVIATION 19.657 • n=7 Participants
|
59.73 years
STANDARD_DEVIATION 7.541 • n=5 Participants
|
61.67 years
STANDARD_DEVIATION 9.352 • n=4 Participants
|
58.45 years
STANDARD_DEVIATION 12.425 • n=21 Participants
|
56.73 years
STANDARD_DEVIATION 7.267 • n=8 Participants
|
59.77 years
STANDARD_DEVIATION 6.959 • n=8 Participants
|
67.10 years
STANDARD_DEVIATION 1.212 • n=24 Participants
|
62.02 years
STANDARD_DEVIATION 7.598 • n=42 Participants
|
57.10 years
STANDARD_DEVIATION 25.069 • n=42 Participants
|
60.18 years
STANDARD_DEVIATION 10.205 • n=42 Participants
|
59.43 years
STANDARD_DEVIATION 18.595 • n=42 Participants
|
60.08 years
STANDARD_DEVIATION 11.471 • n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
30 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
33 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
51 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
African
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
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
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
West Asian (Indian sub-continent)
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
3 participants
n=8 Participants
|
6 participants
n=8 Participants
|
3 participants
n=24 Participants
|
13 participants
n=42 Participants
|
4 participants
n=42 Participants
|
4 participants
n=42 Participants
|
6 participants
n=42 Participants
|
63 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (21 days): Day 1, 5 and 9, any AE reportedPopulation: All participants who received at least 1 dose of LY2523355.
The recommended dose and schedule for Phase 2 studies is defined as the maximum tolerated dose (MTD). MTD is defined as the dose level at which no more than 2 dose limiting toxicities (DLTs), no more than 3 dose reductions (DR) or dose omissions (DO) and no more than 1 DLT plus 2 DR/DO occurred. DLT is defined as an adverse event (AE) occurring in Cycle 1 with the following criteria according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0: Any ≥Grade 3 nonhematological toxicity (except nausea/vomiting or diarrhea controlled with treatment or fatigue); ≥Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia with bleeding; Grade 4 hematological toxicity of \>5 days duration, excluding thrombocytopenia; febrile neutropenia.
Outcome measures
| Measure |
LY2523355 / LY2523355 +PEG
n=63 Participants
Escalating doses starting at 2 milligrams per meter squared per day (mg/m\^2/day) LY2523355 administered by intravenous infusion over 1 hour on Days 1, 5, and 9; escalating doses starting at 8 mg/m\^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 8 or Days 1 and 5 plus 6 mg pegfilgrastim (PEG) administered subcutaneously on Day 6; or 12 mg/m\^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 4 plus 6 mg PEG administered subcutaneously on Day 5 of 21-day cycle for 2 planned cycles and any subsequent cycle up to 38 cycles of 21-days. The maximum allowed dose was 30 mg/m\^2/day.
|
Part A - Days 1, 5, 9 - 4 mg/m^2/Day
4 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 8 mg/m^2/Day
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 7 mg/m^2/Day
7 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 6 mg/m^2/Day
6 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 5 mg/m^2/Day
5 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 8 - 8 mg/m^2/Day
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
|
Part A - Days 1, 5+PEG - 8 mg/m2/Day
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 12 mg/m^2/Day
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 16 mg/m^2/Day
16 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 14 mg/m^2/Day
14 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 5+PEG - 12 mg/m^2/Day
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 4+PEG - 12 mg/m^2/d
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Recommended Dose and Schedule for Phase 2 Studies
|
8 mg/m^2/day
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Cycle 38 (21-day cycles): daily for AEsPopulation: All participants who had at least 1 dose of LY2523355.
Clinically significant effects were defined as serious and other non-serious adverse events (AEs). A summary of serious and other non-serious AEs is located in the Reported Adverse Events module.
Outcome measures
| Measure |
LY2523355 / LY2523355 +PEG
n=3 Participants
Escalating doses starting at 2 milligrams per meter squared per day (mg/m\^2/day) LY2523355 administered by intravenous infusion over 1 hour on Days 1, 5, and 9; escalating doses starting at 8 mg/m\^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 8 or Days 1 and 5 plus 6 mg pegfilgrastim (PEG) administered subcutaneously on Day 6; or 12 mg/m\^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 4 plus 6 mg PEG administered subcutaneously on Day 5 of 21-day cycle for 2 planned cycles and any subsequent cycle up to 38 cycles of 21-days. The maximum allowed dose was 30 mg/m\^2/day.
|
Part A - Days 1, 5, 9 - 4 mg/m^2/Day
n=3 Participants
4 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 8 mg/m^2/Day
n=6 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 7 mg/m^2/Day
n=6 Participants
7 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 6 mg/m^2/Day
n=6 Participants
6 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 5 mg/m^2/Day
n=3 Participants
5 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 8 - 8 mg/m^2/Day
n=6 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
|
Part A - Days 1, 5+PEG - 8 mg/m2/Day
n=3 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 12 mg/m^2/Day
n=3 Participants
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 16 mg/m^2/Day
n=4 Participants
16 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 14 mg/m^2/Day
n=4 Participants
14 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 5+PEG - 12 mg/m^2/Day
n=10 Participants
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 4+PEG - 12 mg/m^2/d
n=6 Participants
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Effects
Serious AEs
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Clinically Significant Effects
Other Non-Serious AEs
|
3 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 of 21-day cycle: Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdosePopulation: All participants who received 1 dose of LY2523355 and had Cmax samples collected on Day 1 of Cycle 1.
Plasma Cmax following a single dose of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).
Outcome measures
| Measure |
LY2523355 / LY2523355 +PEG
n=3 Participants
Escalating doses starting at 2 milligrams per meter squared per day (mg/m\^2/day) LY2523355 administered by intravenous infusion over 1 hour on Days 1, 5, and 9; escalating doses starting at 8 mg/m\^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 8 or Days 1 and 5 plus 6 mg pegfilgrastim (PEG) administered subcutaneously on Day 6; or 12 mg/m\^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 4 plus 6 mg PEG administered subcutaneously on Day 5 of 21-day cycle for 2 planned cycles and any subsequent cycle up to 38 cycles of 21-days. The maximum allowed dose was 30 mg/m\^2/day.
|
Part A - Days 1, 5, 9 - 4 mg/m^2/Day
n=3 Participants
4 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 8 mg/m^2/Day
n=3 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 7 mg/m^2/Day
n=6 Participants
7 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 6 mg/m^2/Day
n=6 Participants
6 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 5 mg/m^2/Day
n=15 Participants
5 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 8 - 8 mg/m^2/Day
n=19 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
|
Part A - Days 1, 5+PEG - 8 mg/m2/Day
n=4 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 12 mg/m^2/Day
n=4 Participants
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 16 mg/m^2/Day
16 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 14 mg/m^2/Day
14 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 5+PEG - 12 mg/m^2/Day
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 4+PEG - 12 mg/m^2/d
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics Maximum Concentration (Cmax), Single Dose
|
45.2 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
126 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
137 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 81
|
196 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 40
|
218 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 26
|
192 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
379 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 10
|
598 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
463 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 43
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdosePopulation: All participants who received 2 doses of study drug and had a Cmax sample collected on Days 4, 5, 8 or 9 of Cycle 1 (based on schedule of administration) after multiple dose administration of LY2523355.
Plasma Cmax following multiple doses of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).
Outcome measures
| Measure |
LY2523355 / LY2523355 +PEG
n=3 Participants
Escalating doses starting at 2 milligrams per meter squared per day (mg/m\^2/day) LY2523355 administered by intravenous infusion over 1 hour on Days 1, 5, and 9; escalating doses starting at 8 mg/m\^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 8 or Days 1 and 5 plus 6 mg pegfilgrastim (PEG) administered subcutaneously on Day 6; or 12 mg/m\^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 4 plus 6 mg PEG administered subcutaneously on Day 5 of 21-day cycle for 2 planned cycles and any subsequent cycle up to 38 cycles of 21-days. The maximum allowed dose was 30 mg/m\^2/day.
|
Part A - Days 1, 5, 9 - 4 mg/m^2/Day
n=3 Participants
4 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 8 mg/m^2/Day
n=3 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 7 mg/m^2/Day
n=6 Participants
7 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 6 mg/m^2/Day
n=4 Participants
6 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 5 mg/m^2/Day
n=11 Participants
5 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 8 - 8 mg/m^2/Day
n=19 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
|
Part A - Days 1, 5+PEG - 8 mg/m2/Day
n=4 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 12 mg/m^2/Day
n=4 Participants
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 16 mg/m^2/Day
16 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 14 mg/m^2/Day
14 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 5+PEG - 12 mg/m^2/Day
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 4+PEG - 12 mg/m^2/d
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics Maximum Concentration (Cmax), Multiple Dose
|
49.1 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 15
|
121 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 58
|
196 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 43
|
124 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 40
|
200 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 69
|
186 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 42
|
367 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
415 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 46
|
485 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 45
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdosePopulation: All participants who received 1 dose of LY2523355 and had pharmacokinetic samples collected on Day 1 of Cycle 1 to enable calculation of AUC(0-∞) and AUC(0-24).
Plasma AUC from time zero to infinity \[AUC(0-∞)\] and AUC from time zero to 24 hours post-dose \[AUC(0-24)\] following a single dose of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).
Outcome measures
| Measure |
LY2523355 / LY2523355 +PEG
n=3 Participants
Escalating doses starting at 2 milligrams per meter squared per day (mg/m\^2/day) LY2523355 administered by intravenous infusion over 1 hour on Days 1, 5, and 9; escalating doses starting at 8 mg/m\^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 8 or Days 1 and 5 plus 6 mg pegfilgrastim (PEG) administered subcutaneously on Day 6; or 12 mg/m\^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 4 plus 6 mg PEG administered subcutaneously on Day 5 of 21-day cycle for 2 planned cycles and any subsequent cycle up to 38 cycles of 21-days. The maximum allowed dose was 30 mg/m\^2/day.
|
Part A - Days 1, 5, 9 - 4 mg/m^2/Day
n=3 Participants
4 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 8 mg/m^2/Day
n=3 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 7 mg/m^2/Day
n=6 Participants
7 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 6 mg/m^2/Day
n=6 Participants
6 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 5 mg/m^2/Day
n=15 Participants
5 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 8 - 8 mg/m^2/Day
n=19 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
|
Part A - Days 1, 5+PEG - 8 mg/m2/Day
n=4 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 12 mg/m^2/Day
n=4 Participants
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 16 mg/m^2/Day
16 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 14 mg/m^2/Day
14 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 5+PEG - 12 mg/m^2/Day
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 4+PEG - 12 mg/m^2/d
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics Area Under the Concentration-time Curve (AUC), Single Dose
AUC(0-∞)
|
158 nanograms*hour/milliter (ng*hr/mL)
Geometric Coefficient of Variation 55
|
517 nanograms*hour/milliter (ng*hr/mL)
Geometric Coefficient of Variation 71
|
584 nanograms*hour/milliter (ng*hr/mL)
Geometric Coefficient of Variation 70
|
648 nanograms*hour/milliter (ng*hr/mL)
Geometric Coefficient of Variation 45
|
758 nanograms*hour/milliter (ng*hr/mL)
Geometric Coefficient of Variation 32
|
669 nanograms*hour/milliter (ng*hr/mL)
Geometric Coefficient of Variation 28
|
1400 nanograms*hour/milliter (ng*hr/mL)
Geometric Coefficient of Variation 41
|
2050 nanograms*hour/milliter (ng*hr/mL)
Geometric Coefficient of Variation 23
|
1900 nanograms*hour/milliter (ng*hr/mL)
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics Area Under the Concentration-time Curve (AUC), Single Dose
AUC(0-24)
|
106 nanograms*hour/milliter (ng*hr/mL)
Geometric Coefficient of Variation 47
|
351 nanograms*hour/milliter (ng*hr/mL)
Geometric Coefficient of Variation 63
|
366 nanograms*hour/milliter (ng*hr/mL)
Geometric Coefficient of Variation 57
|
507 nanograms*hour/milliter (ng*hr/mL)
Geometric Coefficient of Variation 30
|
566 nanograms*hour/milliter (ng*hr/mL)
Geometric Coefficient of Variation 32
|
513 nanograms*hour/milliter (ng*hr/mL)
Geometric Coefficient of Variation 27
|
1040 nanograms*hour/milliter (ng*hr/mL)
Geometric Coefficient of Variation 37
|
1620 nanograms*hour/milliter (ng*hr/mL)
Geometric Coefficient of Variation 24
|
1400 nanograms*hour/milliter (ng*hr/mL)
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdosePopulation: All participants who received 2 doses of study drug and had pharmacokinetic samples collected on Day 4, 5, 8, or 9 of Cycle 1 (based on schedule of administration) to enable calculation of AUC(0-∞) and AUC(0-24) after multiple dose administration of LY2523355.
Plasma AUC from time zero to infinity (0-∞) and AUC from time zero to 24 hours (0-24) post-dose following multiple doses of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).
Outcome measures
| Measure |
LY2523355 / LY2523355 +PEG
n=3 Participants
Escalating doses starting at 2 milligrams per meter squared per day (mg/m\^2/day) LY2523355 administered by intravenous infusion over 1 hour on Days 1, 5, and 9; escalating doses starting at 8 mg/m\^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 8 or Days 1 and 5 plus 6 mg pegfilgrastim (PEG) administered subcutaneously on Day 6; or 12 mg/m\^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 4 plus 6 mg PEG administered subcutaneously on Day 5 of 21-day cycle for 2 planned cycles and any subsequent cycle up to 38 cycles of 21-days. The maximum allowed dose was 30 mg/m\^2/day.
|
Part A - Days 1, 5, 9 - 4 mg/m^2/Day
n=3 Participants
4 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 8 mg/m^2/Day
n=3 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 7 mg/m^2/Day
n=6 Participants
7 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 6 mg/m^2/Day
n=4 Participants
6 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 5 mg/m^2/Day
n=11 Participants
5 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 8 - 8 mg/m^2/Day
n=19 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
|
Part A - Days 1, 5+PEG - 8 mg/m2/Day
n=4 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 12 mg/m^2/Day
n=4 Participants
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 16 mg/m^2/Day
16 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 14 mg/m^2/Day
14 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 5+PEG - 12 mg/m^2/Day
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 4+PEG - 12 mg/m^2/d
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Areas Under the Concentration Time Curve (AUC), Multiple Dose
AUC(0-∞)
|
172 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 34
|
377 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 73
|
718 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 52
|
356 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 43
|
717 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 66
|
575 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 38
|
1340 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 49
|
1280 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 43
|
1510 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic Areas Under the Concentration Time Curve (AUC), Multiple Dose
AUC(0-24)
|
130 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 27
|
308 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 77
|
508 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 34
|
298 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 37
|
562 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 66
|
452 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 37
|
956 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 40
|
1110 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 46
|
1230 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to measured disease progression or discontinuation up to Cycle 38 (21-day cycles)Population: All participants who received 1 dose of LY2523355.
Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria and the Revised International Working Group (IWG) lymphoma response criteria for lymphoma patients. 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 at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Tumor response is CR + PR.
Outcome measures
| Measure |
LY2523355 / LY2523355 +PEG
n=27 Participants
Escalating doses starting at 2 milligrams per meter squared per day (mg/m\^2/day) LY2523355 administered by intravenous infusion over 1 hour on Days 1, 5, and 9; escalating doses starting at 8 mg/m\^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 8 or Days 1 and 5 plus 6 mg pegfilgrastim (PEG) administered subcutaneously on Day 6; or 12 mg/m\^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 4 plus 6 mg PEG administered subcutaneously on Day 5 of 21-day cycle for 2 planned cycles and any subsequent cycle up to 38 cycles of 21-days. The maximum allowed dose was 30 mg/m\^2/day.
|
Part A - Days 1, 5, 9 - 4 mg/m^2/Day
n=6 Participants
4 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 8 mg/m^2/Day
n=24 Participants
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 7 mg/m^2/Day
n=6 Participants
7 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 6 mg/m^2/Day
6 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 5 mg/m^2/Day
5 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 8 - 8 mg/m^2/Day
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
|
Part A - Days 1, 5+PEG - 8 mg/m2/Day
8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 12 mg/m^2/Day
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 16 mg/m^2/Day
16 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 14 mg/m^2/Day
14 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 5+PEG - 12 mg/m^2/Day
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 4+PEG - 12 mg/m^2/d
12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Tumor Response
|
0 participants
Interval 0.0 to 0.0
|
0 participants
Interval 0.0 to 0.0
|
0 participants
Interval 0.0 to 0.0
|
0 participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A - Days 1, 5, 9 - 2 mg/m^2/Day
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A - Days 1, 5, 9 - 4 mg/m^2/Day
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A - Days 1, 5, 9 - 8 mg/m^2/Day
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A - Days 1, 5, 9 - 7 mg/m^2/Day
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A - Days 1, 5, 9 - 6 mg/m^2/Day
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A - Days 1, 5, 9 - 5 mg/m^2/Day
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A - Days 1, 8 - 8 mg/m^2/Day
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A - Days 1, 5+PEG - 8 mg/m^2/Day
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A - Days 1, 5+PEG - 12 mg/m^2/Day
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A - Days 1, 5+PEG - 16 mg/m^2/Day
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A - Days 1, 5+PEG - 14 mg/m^2/Day
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B - Days 1, 5+PEG - 12 mg/m^2/Day
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Part B - Days 1, 4+PEG - 12 mg/m^2/d
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A - Days 1, 5, 9 - 2 mg/m^2/Day
n=3 participants at risk
Part A (Dose Escalation Phase): 2 milligrams per meter squared per day (mg/m\^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 4 mg/m^2/Day
n=3 participants at risk
Part A (Dose Escalation Phase): 4 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 8 mg/m^2/Day
n=6 participants at risk
Part A (Dose Escalation Phase): 8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 7 mg/m^2/Day
n=6 participants at risk
Part A (Dose Escalation Phase): 7 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 6 mg/m^2/Day
n=6 participants at risk
Part A (Dose Escalation Phase): 6 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 5 mg/m^2/Day
n=3 participants at risk
Part A (Dose Escalation Phase): 5 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 8 - 8 mg/m^2/Day
n=6 participants at risk
Part A (Dose Escalation Phase): 8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
|
Part A - Days 1, 5+PEG - 8 mg/m^2/Day
n=3 participants at risk
Part A (Dose Escalation Phase): 8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 12 mg/m^2/Day
n=3 participants at risk
Part A (Dose Escalation Phase): 12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 16 mg/m^2/Day
n=4 participants at risk
Part A (Dose Escalation Phase): 16 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 14 mg/m^2/Day
n=4 participants at risk
Part A (Dose Escalation Phase): 14 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 5+PEG - 12 mg/m^2/Day
n=10 participants at risk
Part B (Dose Maintenance Phase): 12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 4+PEG - 12 mg/m^2/d
n=6 participants at risk
Part B (Dose Maintenance Phase): 12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
General disorders
Asthenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Oedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
Other adverse events
| Measure |
Part A - Days 1, 5, 9 - 2 mg/m^2/Day
n=3 participants at risk
Part A (Dose Escalation Phase): 2 milligrams per meter squared per day (mg/m\^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 4 mg/m^2/Day
n=3 participants at risk
Part A (Dose Escalation Phase): 4 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 8 mg/m^2/Day
n=6 participants at risk
Part A (Dose Escalation Phase): 8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 7 mg/m^2/Day
n=6 participants at risk
Part A (Dose Escalation Phase): 7 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 6 mg/m^2/Day
n=6 participants at risk
Part A (Dose Escalation Phase): 6 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 5, 9 - 5 mg/m^2/Day
n=3 participants at risk
Part A (Dose Escalation Phase): 5 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.
|
Part A - Days 1, 8 - 8 mg/m^2/Day
n=6 participants at risk
Part A (Dose Escalation Phase): 8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.
|
Part A - Days 1, 5+PEG - 8 mg/m^2/Day
n=3 participants at risk
Part A (Dose Escalation Phase): 8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 12 mg/m^2/Day
n=3 participants at risk
Part A (Dose Escalation Phase): 12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 16 mg/m^2/Day
n=4 participants at risk
Part A (Dose Escalation Phase): 16 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part A - Days 1, 5+PEG - 14 mg/m^2/Day
n=4 participants at risk
Part A (Dose Escalation Phase): 14 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 5+PEG - 12 mg/m^2/Day
n=10 participants at risk
Part B (Dose Maintenance Phase): 12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.
|
Part B - Days 1, 4+PEG - 12 mg/m^2/d
n=6 participants at risk
Part B (Dose Maintenance Phase): 12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously Day 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/6
|
66.7%
2/3 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
40.0%
4/10 • Number of events 4
|
50.0%
3/6 • Number of events 3
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
3/6 • Number of events 3
|
66.7%
4/6 • Number of events 4
|
83.3%
5/6 • Number of events 5
|
66.7%
2/3 • Number of events 2
|
83.3%
5/6 • Number of events 5
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
33.3%
2/6 • Number of events 2
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Eye disorders
Blindness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Eye disorders
Dry eye
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Visual impairment
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Anorectal discomfort
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
50.0%
3/6 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
66.7%
4/6 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
50.0%
2/4 • Number of events 2
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
50.0%
3/6 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
30.0%
3/10 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
Haematochezia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Mucous stools
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
30.0%
3/10 • Number of events 3
|
50.0%
3/6 • Number of events 3
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
50.0%
3/6 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
30.0%
3/10 • Number of events 3
|
50.0%
3/6 • Number of events 3
|
|
General disorders
Asthenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Catheter site pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
General disorders
Chest pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
General disorders
Chills
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Early satiety
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
General disorders
Face oedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
General disorders
Facial pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
66.7%
4/6 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
100.0%
3/3 • Number of events 3
|
83.3%
5/6 • Number of events 5
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
50.0%
2/4 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
70.0%
7/10 • Number of events 7
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Feeling cold
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Gait disturbance
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Injection site pruritus
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
50.0%
2/4 • Number of events 2
|
0.00%
0/4
|
40.0%
4/10 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Oedema
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
30.0%
3/10 • Number of events 3
|
0.00%
0/6
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
40.0%
4/10 • Number of events 4
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Temperature intolerance
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Ulcer
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Candidiasis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Central line infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Rhinitis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Viral infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Investigations
Blood cortisol increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Investigations
Blood glucose decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Investigations
Blood iron decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Investigations
Blood potassium decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Investigations
Blood potassium increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Investigations
Calcium ionised decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Prothrombin time ratio increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Investigations
Urine output decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Investigations
Weight decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Investigations
White blood cell count increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
3/6 • Number of events 3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
20.0%
2/10 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
50.0%
2/4 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
50.0%
2/4 • Number of events 2
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Nervous system disorders
Drooling
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
30.0%
3/10 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Nervous system disorders
Syncope
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
66.7%
2/3 • Number of events 2
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Depression
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Psychiatric disorders
Sleep talking
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Reproductive system and breast disorders
Penile oedema
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/2
|
—
0/0
|
25.0%
1/4 • Number of events 1
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/2
|
—
0/0
|
25.0%
1/4 • Number of events 1
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
0.00%
0/5
|
0.00%
0/2
|
—
0/0
|
0.00%
0/4
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/2
|
0.00%
0/1
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Vulval disorder
|
0.00%
0/2
|
0.00%
0/1
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/2
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/2
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/2
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
20.0%
2/10 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
50.0%
2/4 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Vascular disorders
Hypertension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/10
|
0.00%
0/6
|
|
Vascular disorders
Hypotension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/10
|
16.7%
1/6 • 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