Trial Outcomes & Findings for A Study for Patients With Acute Leukemia (NCT NCT01214655)
NCT ID: NCT01214655
Last Updated: 2019-05-13
Results Overview
The recommended dose and schedule for Phase 2 studies of LY2523355 with acute leukemia was determined by a modification of the continual reassessment method. The sample size to adequately determine the maximum tolerated dose (MTD) for both schedules in this study was a function of a priori estimates for the dose-toxicity relationship as well as the initial dose in each schedule, the rate of dose escalation, and the observed dose-toxicity relationship. Before MTD could be determined for Part B (Days 1, 5, and 9 of a 21-day cycle), this study was paused for futility analysis.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
Baseline up to the end of Cycle 2 (Day 42)
Results posted on
2019-05-13
Participant Flow
A participant was considered to have completed the trial if they received at 2 cycles of treatment. Participant Flow Arms represent schedule of dosing, with dose escalation, dose levels and participants who joined the dose level presented as Milestones. Study was based on best Schedule of dosing, not dose levels.
Participant milestones
| Measure |
Schedule A LY2523355
Participants received a dose escalation to maximum tolerated dose (MTD) from 2 mg/m²/day to 4,5 and 6 mg/m²/day during a 1 hour (hr) infusion on Days 1,2, 3 (Schedule A) of a 21 day cycle. Participants did not have to escalate doses and participants could join at a higher dose level.
|
Schedule B LY2523355
Participants received a dose escalation to maximum tolerated dose (MTD) ranging from 8 mg/m²/day (starting dose) to 10,12 and 14 mg/m²/day during a 1 hour (hr) infusion on Days 1,5, 9 (Schedule B)of a 21 day cycle Participants did not have to escalate doses and participants could join at a higher dose level.
|
Schedule C LY2523355
Starting dose was 5 mg/m²/day administered by IV infusion over 1 hour on Days 1, 2, and 3 (Schedule C) of every 21-day Cycle.
|
|---|---|---|---|
|
Part A
STARTED
|
10
|
0
|
0
|
|
Part A
Received 2 mg Study Drug
|
3
|
0
|
0
|
|
Part A
Escalated From 2 to 4 mg/m²/Day
|
3
|
0
|
0
|
|
Part A
Joined 4 mg Group
|
1
|
0
|
0
|
|
Part A
Escalated From 4 mg Study Drug
|
0
|
0
|
0
|
|
Part A
Joined 5 mg Study Drug
|
2
|
0
|
0
|
|
Part A
Escalated From 5 mg Study Drug
|
1
|
0
|
0
|
|
Part A
Joined 6 mg Group
|
4
|
0
|
0
|
|
Part A
Received 6 mg Study Drug
|
5
|
0
|
0
|
|
Part A
COMPLETED
|
2
|
0
|
0
|
|
Part A
NOT COMPLETED
|
8
|
0
|
0
|
|
Part B
STARTED
|
0
|
15
|
0
|
|
Part B
Received at Least 1 Dose of Study Drug
|
0
|
15
|
0
|
|
Part B
Recieved 8 mg/m²/Day Study Drug
|
0
|
4
|
0
|
|
Part B
Escalated From 8 to 10 mg/m²/Day
|
0
|
2
|
0
|
|
Part B
Joined 10 mg/m²/Day Study D
|
0
|
3
|
0
|
|
Part B
Escalated to 12 mg/m²/Day
|
0
|
2
|
0
|
|
Part B
Joined 12 mg/m²/Day
|
0
|
5
|
0
|
|
Part B
Escalated From 12 to 14 mg/m²/Day
|
0
|
1
|
0
|
|
Part B
Joined 14 mg/m²/Day
|
0
|
3
|
0
|
|
Part B
COMPLETED
|
0
|
2
|
0
|
|
Part B
NOT COMPLETED
|
0
|
13
|
0
|
|
Part C
STARTED
|
0
|
0
|
8
|
|
Part C
Received at Least 1 Dose of 5 mg/m²/Day
|
0
|
0
|
8
|
|
Part C
COMPLETED
|
0
|
0
|
1
|
|
Part C
NOT COMPLETED
|
0
|
0
|
7
|
Reasons for withdrawal
| Measure |
Schedule A LY2523355
Participants received a dose escalation to maximum tolerated dose (MTD) from 2 mg/m²/day to 4,5 and 6 mg/m²/day during a 1 hour (hr) infusion on Days 1,2, 3 (Schedule A) of a 21 day cycle. Participants did not have to escalate doses and participants could join at a higher dose level.
|
Schedule B LY2523355
Participants received a dose escalation to maximum tolerated dose (MTD) ranging from 8 mg/m²/day (starting dose) to 10,12 and 14 mg/m²/day during a 1 hour (hr) infusion on Days 1,5, 9 (Schedule B)of a 21 day cycle Participants did not have to escalate doses and participants could join at a higher dose level.
|
Schedule C LY2523355
Starting dose was 5 mg/m²/day administered by IV infusion over 1 hour on Days 1, 2, and 3 (Schedule C) of every 21-day Cycle.
|
|---|---|---|---|
|
Part A
Progressive Disease
|
7
|
0
|
0
|
|
Part A
Physician Decision
|
1
|
0
|
0
|
|
Part B
Progressive disease
|
0
|
10
|
0
|
|
Part B
Death
|
0
|
1
|
0
|
|
Part B
Withdrawal by Subject
|
0
|
2
|
0
|
|
Part C
Progressive Disease
|
0
|
0
|
5
|
|
Part C
Death
|
0
|
0
|
1
|
|
Part C
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
A Study for Patients With Acute Leukemia
Baseline characteristics by cohort
| Measure |
Schedule A LY2523355
n=10 Participants
Starting dose was 2 milligrams per meter squared per day (mg/m\^2/day) administered by intravenous (IV) infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle.
|
Schedule B LY2523355
n=15 Participants
Starting dose was 8 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.
|
Schedule C LY2523355
n=8 Participants
Starting dose was 5 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle.
No participants in Part C escalated from their initial dose.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 19.43 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 12.98 • n=7 Participants
|
70.7 years
STANDARD_DEVIATION 5.75 • n=5 Participants
|
66.0 years
STANDARD_DEVIATION 13.98 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
West Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG Status 0
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG Status 1
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG Status 2
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to the end of Cycle 2 (Day 42)Population: Participants who received at least one dose of study medication (LY2523355).
The recommended dose and schedule for Phase 2 studies of LY2523355 with acute leukemia was determined by a modification of the continual reassessment method. The sample size to adequately determine the maximum tolerated dose (MTD) for both schedules in this study was a function of a priori estimates for the dose-toxicity relationship as well as the initial dose in each schedule, the rate of dose escalation, and the observed dose-toxicity relationship. Before MTD could be determined for Part B (Days 1, 5, and 9 of a 21-day cycle), this study was paused for futility analysis.
Outcome measures
| Measure |
LY2523355
n=33 Participants
Escalating doses starting at 2 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A of the study. Escalating doses starting at 8 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle in Part B of the study. Dose of 5 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle in Part C of the study.
|
Schedule B LY2523355
Starting dose was 8 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.
|
Schedule C LY2523355
Starting dose was 5 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle.
|
Schedule A 6 mg LY2523355
6 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
|
Schedule B 8 mg LY2523355
8 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 10 mg LY2523355
10 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 12 mg LY2523355
12 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle.
|
Schedule B 14 mg 2523355
14 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 16 mg LY2523355
16 mg/m²/day was inadvertently given to a participant.
|
|---|---|---|---|---|---|---|---|---|---|
|
Recommended Dose and Schedule for Phase 2 Studies in Acute Leukemia
|
5 mg/m^2/day; Days 1, 2, and 3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to study completion (up to 213 days)Population: Participants who received at least one dose of study medication (LY2523355).
Clinically significant effects were defined as serious and other non-serious adverse events (AEs). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
LY2523355
n=10 Participants
Escalating doses starting at 2 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A of the study. Escalating doses starting at 8 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle in Part B of the study. Dose of 5 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle in Part C of the study.
|
Schedule B LY2523355
n=15 Participants
Starting dose was 8 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.
|
Schedule C LY2523355
n=8 Participants
Starting dose was 5 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle.
|
Schedule A 6 mg LY2523355
6 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
|
Schedule B 8 mg LY2523355
8 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 10 mg LY2523355
10 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 12 mg LY2523355
12 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle.
|
Schedule B 14 mg 2523355
14 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 16 mg LY2523355
16 mg/m²/day was inadvertently given to a participant.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Effects
|
7 Participants
|
9 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1(Day 1),: Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr, 48 hr, 72 hr postdosePopulation: Participants who received one dose of LY2523355 on Day 1 of Cycle 1(Schedule A,B,C) with evaluable pharmacokinetic data to enable determination of the LY2523355 plasma Cmax on Day 1. Schedule A,C data was combined for 5 mg, 2 participants received and incorrect dose of 6 mg and 16 mg are included in data.
The maximum plasma concentration (Cmax) was the maximum plasma concentration obtained from the plasma concentration versus time curves of LY2523355 were calculated to assess intra and intercycle variability, depending on dosage cycle.
Outcome measures
| Measure |
LY2523355
n=3 Participants
Escalating doses starting at 2 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A of the study. Escalating doses starting at 8 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle in Part B of the study. Dose of 5 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle in Part C of the study.
|
Schedule B LY2523355
n=1 Participants
Starting dose was 8 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.
|
Schedule C LY2523355
n=7 Participants
Starting dose was 5 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle.
|
Schedule A 6 mg LY2523355
n=6 Participants
6 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
|
Schedule B 8 mg LY2523355
n=5 Participants
8 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 10 mg LY2523355
n=3 Participants
10 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 12 mg LY2523355
n=4 Participants
12 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle.
|
Schedule B 14 mg 2523355
n=2 Participants
14 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 16 mg LY2523355
n=1 Participants
16 mg/m²/day was inadvertently given to a participant.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics, Maximum Plasma Concentration (Cmax), Single Dose
|
198 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 1410
|
895 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
N=1, individual data presented
|
240 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 420
|
391 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 254
|
169 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 47
|
354 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 66
|
254 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 18
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
N=2,individual values presented (263 and 657), no CV calculated due to N of 2
|
17,000 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
N=1, individual data presented
|
SECONDARY outcome
Timeframe: Days 3 (Parts A or C) or 9 (Part B), Cycle 1: Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr, 48 hr, 72 hr postdosePopulation: Participants who received more than one dose of LY2523355 with evaluable pharmacokinetic data, Schedules A,B,C.
The maximum plasma concentration (Cmax) was the maximum plasma concentration obtained from the plasma concentration versus time curves of LY2523355. Multiple dose LY2523355 plasma Cmax values are shown at each dose level for both schedules of administration (Day 3 of Cycle 1 for the Day 1, 2, and 3 schedule of administration and Day 9 of Cycle 1 for the Days 1, 5, and 9 schedule of administration). The maximum plasma concentration (Cmax) was the maximum plasma concentration obtained from the plasma concentration versus time curves of LY2523355 were calculated to assess intra and intercycle variability, depending on dosage cycle.
Outcome measures
| Measure |
LY2523355
n=3 Participants
Escalating doses starting at 2 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A of the study. Escalating doses starting at 8 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle in Part B of the study. Dose of 5 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle in Part C of the study.
|
Schedule B LY2523355
n=1 Participants
Starting dose was 8 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.
|
Schedule C LY2523355
n=9 Participants
Starting dose was 5 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle.
|
Schedule A 6 mg LY2523355
n=5 Participants
6 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
|
Schedule B 8 mg LY2523355
n=3 Participants
8 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 10 mg LY2523355
n=3 Participants
10 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 12 mg LY2523355
n=2 Participants
12 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle.
|
Schedule B 14 mg 2523355
n=1 Participants
14 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 16 mg LY2523355
16 mg/m²/day was inadvertently given to a participant.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics, Maximum Plasma Concentration (Cmax), Multiple Dose
|
43.1 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 46
|
2440 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
N=1, Individual parameter listed
|
439 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 391
|
187 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 69
|
155 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 139
|
283 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 23
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
N=2. individual numbers listed: 300;14,490
|
892 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
N=1,Individual parameters listed
|
—
|
SECONDARY outcome
Timeframe: Day 1, Cycle 1: Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr, 48 hr, 72 hr postdosePopulation: Participants who received one dose of LY2523355 on Day 1 of Cycle 1 with evaluable pharmacokinetic data to enable calculation of the LY2523355 AUC on Day 1 of Cycle 1.Schedule A,C data was combined for 5 mg, 2 participants received and incorrect dose of 6 mg and 16 mg are included in data.
The AUC(0-24) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to 24 hours. The AUC(0-inf) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to infinity. Single dose LY2523355 AUC values are shown for each dose level for Day 1 of Cycle 1 for both schedules of administration. When only individual participant parameters are available or N=2, for a given dose, the AUC CV is not calculated for that dose group and is not presented (4 milligrams per meter squared per day \[mg/m\^2/day\], 14 mg/m\^2/day, 12 mg/m\^2/day and 16 mg/m\^2/day). Individual data will be presented.
Outcome measures
| Measure |
LY2523355
n=3 Participants
Escalating doses starting at 2 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A of the study. Escalating doses starting at 8 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle in Part B of the study. Dose of 5 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle in Part C of the study.
|
Schedule B LY2523355
n=1 Participants
Starting dose was 8 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.
|
Schedule C LY2523355
n=9 Participants
Starting dose was 5 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle.
|
Schedule A 6 mg LY2523355
n=5 Participants
6 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
|
Schedule B 8 mg LY2523355
n=3 Participants
8 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 10 mg LY2523355
n=3 Participants
10 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 12 mg LY2523355
n=2 Participants
12 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle.
|
Schedule B 14 mg 2523355
n=2 Participants
14 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 16 mg LY2523355
n=1 Participants
16 mg/m²/day was inadvertently given to a participant.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics, Area Under the Concentration Versus Time Curve (AUC), Single Dose
The AUC(0-24)
|
278 nanagram hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 209
|
3420 nanagram hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
N=1, individual data presented
|
473 nanagram hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 163
|
613 nanagram hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 92
|
469 nanagram hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 22
|
1060 nanagram hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 31
|
746 nanagram hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 46
|
NA nanagram hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
N=2, no CV, individual values presented: 814,1670
|
8770 nanagram hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
N=1, individual data presented
|
|
Pharmacokinetics, Area Under the Concentration Versus Time Curve (AUC), Single Dose
The AUC(0-inf)
|
229 nanagram hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 191
|
3490 nanagram hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
N=1, individual data presented
|
537 nanagram hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 157
|
675 nanagram hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 86
|
608 nanagram hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 28
|
1530 nanagram hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 29
|
970 nanagram hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 55
|
NA nanagram hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
N=2, no CV, individual values presented: 1150;2270
|
9200 nanagram hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
N=1, individual data presented
|
SECONDARY outcome
Timeframe: Days 3 (Parts A or C) or 9 (Part B):Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr 48 hr, 72 hr postdosePopulation: Participants who received more than one dose of LY2523355 with evaluable pharmacokinetic data on Cycle 1 Day 3 or Day 9, schedule dependent.
The AUC(0-24) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to 24 hours. The AUC(0-inf) was calculated from area under the plasma concentration versus time curves of LY2523355 from time zero to infinity.. Multiple dose LY2523355 AUC values are shown at each dose level for both schedules of administration (Day 3 of Cycle 1 for the Day 1, 2, and 3 schedule of administration and Day 9 of Cycle 1 for the Days 1, 5, and 9 schedule of administration). When only individual participant parameters are available or N=2, for a given dose, the AUC CV is not calculated for that dose group and is not presented (4 milligrams per meter squared per day \[mg/m\^2/day\], 12 mg/m\^2/day, and 14 mg/m\^2/day). Individual data will be presented.
Outcome measures
| Measure |
LY2523355
n=3 Participants
Escalating doses starting at 2 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A of the study. Escalating doses starting at 8 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle in Part B of the study. Dose of 5 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle in Part C of the study.
|
Schedule B LY2523355
n=1 Participants
Starting dose was 8 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.
|
Schedule C LY2523355
n=9 Participants
Starting dose was 5 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle.
|
Schedule A 6 mg LY2523355
n=6 Participants
6 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
|
Schedule B 8 mg LY2523355
n=3 Participants
8 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 10 mg LY2523355
n=3 Participants
10 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 12 mg LY2523355
n=2 Participants
12 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle.
|
Schedule B 14 mg 2523355
n=1 Participants
14 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 16 mg LY2523355
16 mg/m²/day was inadvertently given to a participant.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics, Area Under the Concentration Versus Time (AUC), Multiple Dose
AUC(0-24)
|
134 nanograms hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 38
|
2540 nanograms hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Individual parameter listed
|
696 nanograms hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 126
|
624 nanograms hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 66
|
623 nanograms hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 81
|
844 nanograms hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 14
|
NA nanograms hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
N= 2, individual parameter listed: 1200;6380
|
2910 nanograms hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Individual parameter listed
|
—
|
|
Pharmacokinetics, Area Under the Concentration Versus Time (AUC), Multiple Dose
AUC(0-inf),
|
187 nanograms hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 45
|
3120 nanograms hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Individual parameter listed
|
992 nanograms hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 117
|
990 nanograms hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 107
|
834 nanograms hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 98
|
1050 nanograms hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 8
|
NA nanograms hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
N= 2, individual parameter listed: 1560; 6390
|
4120 nanograms hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Individual parameter listed
|
—
|
SECONDARY outcome
Timeframe: Baseline up to disease progression or discontinuation (up to 213 days)Population: Participants with acute myelogenous leukemia who received at least one dose of study medication (LY2523355).
Response rate for participants with acute myelogenous leukemia include the proportion of participants who achieved a morphologic complete remission, morphologic complete remission with incomplete blood count recovery, cytogenetic complete remission, molecular complete remission, or partial remission. The Revised International Working Group Criteria was used to determine response rate for participants with acute myelogenous leukemia.
Outcome measures
| Measure |
LY2523355
n=5 Participants
Escalating doses starting at 2 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A of the study. Escalating doses starting at 8 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle in Part B of the study. Dose of 5 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle in Part C of the study.
|
Schedule B LY2523355
n=9 Participants
Starting dose was 8 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.
|
Schedule C LY2523355
n=8 Participants
Starting dose was 5 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle.
|
Schedule A 6 mg LY2523355
6 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
|
Schedule B 8 mg LY2523355
8 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 10 mg LY2523355
10 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 12 mg LY2523355
12 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle.
|
Schedule B 14 mg 2523355
14 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 16 mg LY2523355
16 mg/m²/day was inadvertently given to a participant.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Response for Acute Myelogenous Leukemia Using The Revised International Working Group Criteria
|
0.0 percentage of responders
|
11.1 percentage of responders
|
12.5 percentage of responders
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to disease progression or discontinuation (up to 213 days)Population: Participants with chronic myelogenous leukemia in blast crisis who received at least one dose of study medication (LY2523355).
Response rate for participants with chronic myelogenous leukemia in blast crisis include the proportion of participants who achieved a complete hematologic response, had no evidence of leukemia, or had returned to chronic phase. The criteria outlined in Cohen 2005 (Cohen MH, Johnson JR, Pazdur R. 2005. U.S. Food and Drug Administration Drug Approval Summary: conversion of imatinib mesylate (STI571; Gleevec) tablets from accelerated approval to full approval. Clin Cancer Res. 11(1):12-19.) was used to determine response rate for participants with chronic myelogenous leukemia in blast crisis.
Outcome measures
| Measure |
LY2523355
Escalating doses starting at 2 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A of the study. Escalating doses starting at 8 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle in Part B of the study. Dose of 5 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle in Part C of the study.
|
Schedule B LY2523355
n=1 Participants
Starting dose was 8 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.
|
Schedule C LY2523355
Starting dose was 5 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle.
|
Schedule A 6 mg LY2523355
6 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
|
Schedule B 8 mg LY2523355
8 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 10 mg LY2523355
10 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 12 mg LY2523355
12 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle.
|
Schedule B 14 mg 2523355
14 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 16 mg LY2523355
16 mg/m²/day was inadvertently given to a participant.
|
|---|---|---|---|---|---|---|---|---|---|
|
Response Rates for Chronic Myelogenous Leukemia in Blast Crisis (Complete Hematologic Response, no Evidence of Leukemia, Return to Chronic Phase)
|
—
|
0 percentage of responders
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to disease progression or discontinuation (up to 213 days)Population: Participants with acute lymphoblastic leukemia who received at least one dose of study medication (LY2523355).
Response rate for participants with acute lymphoblastic leukemia include the proportion of participants who achieved a morphologic complete remission, morphologic complete remission with incomplete blood count recovery, cytogenetic complete remission, molecular complete remission, or partial remission. The Revised International Working Group Criteria was used to determine response rate for participants with acute lymphoblastic leukemia by early treatment assessment, morphologic leukemia-free state (less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells) and morphologic complete remission (and have an absolute neutrophil count of more than 1000 per microliter and platelets of 100,000 per microliter.
Outcome measures
| Measure |
LY2523355
n=4 Participants
Escalating doses starting at 2 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A of the study. Escalating doses starting at 8 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle in Part B of the study. Dose of 5 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle in Part C of the study.
|
Schedule B LY2523355
Starting dose was 8 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.
|
Schedule C LY2523355
Starting dose was 5 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle.
|
Schedule A 6 mg LY2523355
6 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
|
Schedule B 8 mg LY2523355
8 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 10 mg LY2523355
10 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 12 mg LY2523355
12 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle.
|
Schedule B 14 mg 2523355
14 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 16 mg LY2523355
16 mg/m²/day was inadvertently given to a participant.
|
|---|---|---|---|---|---|---|---|---|---|
|
Response Rate (Percentage) for Acute Lymphoblastic Leukemia Using The Revised International Working Group Criteria
|
25.0 percentage of responders
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to end of treatment follow-up (up to 213 days)Population: Participants who received at least one dose of study medication (LY2523355).
The number of participants who died through the follow-up period of the study. This does not include the outcomes for the two participants who died while on treatment through Cycle 2 as captured in the Participant Flow Table. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
LY2523355
n=10 Participants
Escalating doses starting at 2 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle in Part A of the study. Escalating doses starting at 8 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle in Part B of the study. Dose of 5 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle in Part C of the study.
|
Schedule B LY2523355
n=15 Participants
Starting dose was 8 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.
|
Schedule C LY2523355
n=8 Participants
Starting dose was 5 mg/m\^2/day administered by IV infusion over 1 hour on Days 1, 2, and 3 of every 21-day Cycle.
|
Schedule A 6 mg LY2523355
6 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day cycle.
|
Schedule B 8 mg LY2523355
8 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 10 mg LY2523355
10 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 12 mg LY2523355
12 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1,5, and 9 of every 21-day cycle.
|
Schedule B 14 mg 2523355
14 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 5, and 9 of every 21-day cycle.
|
Schedule B 16 mg LY2523355
16 mg/m²/day was inadvertently given to a participant.
|
|---|---|---|---|---|---|---|---|---|---|
|
Death of Participants on Study up to the Follow-up Period
|
1 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1 LY2523355 2 mg/m^2/Day, Days 1, 2, and 3
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1 LY2523355 4 mg/m^2/Day, Days 1, 2, and 3
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 1 LY2523355 6 mg/m^2/Day, Days 1, 2, and 3
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2 LY2523355 8 mg/m^2/Day, Days 1, 5, and 9
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2 LY2523355 10 mg/m^2/Day, Days 1, 5, and 9
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2 LY2523355 12 mg/m^2/Day, Days 1, 5, and 9
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2 LY2523355 14 mg/m^2/Day, Days 1, 5, and 9
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 3 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 LY2523355 2 mg/m^2/Day, Days 1, 2, and 3
n=3 participants at risk
Dose was 2 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle.
|
Cohort 1 LY2523355 4 mg/m^2/Day, Days 1, 2, and 3
n=4 participants at risk
Dose was 4 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle.
|
Cohort 1 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3
n=2 participants at risk
Dose was 5 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle.
|
Cohort 1 LY2523355 6 mg/m^2/Day, Days 1, 2, and 3
n=5 participants at risk
Dose was 6 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle.
|
Cohort 2 LY2523355 8 mg/m^2/Day, Days 1, 5, and 9
n=4 participants at risk
Dose was 8 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
|
Cohort 2 LY2523355 10 mg/m^2/Day, Days 1, 5, and 9
n=5 participants at risk
Dose was 10 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
|
Cohort 2 LY2523355 12 mg/m^2/Day, Days 1, 5, and 9
n=7 participants at risk
Dose was 12 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
|
Cohort 2 LY2523355 14 mg/m^2/Day, Days 1, 5, and 9
n=4 participants at risk
Dose was 14 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
|
Cohort 3 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3
n=8 participants at risk
Dose was 5 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
2/4 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
1/2 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
40.0%
2/5 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
2/8 • Number of events 5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
12.5%
1/8 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
12.5%
1/8 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
General disorders
Pyrexia
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
12.5%
1/8 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
12.5%
1/8 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
12.5%
1/8 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Vascular disorders
Deep vein thrombosis
|
33.3%
1/3 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
Other adverse events
| Measure |
Cohort 1 LY2523355 2 mg/m^2/Day, Days 1, 2, and 3
n=3 participants at risk
Dose was 2 milligrams per meter squared per day (mg/m\^2/day) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle.
|
Cohort 1 LY2523355 4 mg/m^2/Day, Days 1, 2, and 3
n=4 participants at risk
Dose was 4 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle.
|
Cohort 1 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3
n=2 participants at risk
Dose was 5 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle.
|
Cohort 1 LY2523355 6 mg/m^2/Day, Days 1, 2, and 3
n=5 participants at risk
Dose was 6 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle.
|
Cohort 2 LY2523355 8 mg/m^2/Day, Days 1, 5, and 9
n=4 participants at risk
Dose was 8 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
|
Cohort 2 LY2523355 10 mg/m^2/Day, Days 1, 5, and 9
n=5 participants at risk
Dose was 10 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
|
Cohort 2 LY2523355 12 mg/m^2/Day, Days 1, 5, and 9
n=7 participants at risk
Dose was 12 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
|
Cohort 2 LY2523355 14 mg/m^2/Day, Days 1, 5, and 9
n=4 participants at risk
Dose was 14 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 5, and 9 of every 21-day Cycle.
|
Cohort 3 LY2523355 5 mg/m^2/Day, Days 1, 2, and 3
n=8 participants at risk
Dose was 5 mg/m\^2/day administered by a 1-hour IV infusion on Days 1, 2, and 3 of every 21-day Cycle.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
1/2 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
60.0%
3/5 • Number of events 3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
37.5%
3/8 • Number of events 3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
28.6%
2/7 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Blood and lymphatic system disorders
Leukopenia
|
33.3%
1/3 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
75.0%
3/4 • Number of events 3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
40.0%
2/5 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
2/4 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
1/2 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
42.9%
3/7 • Number of events 3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
2/8 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
66.7%
2/3 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
2/4 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
1/2 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
40.0%
2/5 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
2/8 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
12.5%
1/8 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
40.0%
2/5 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
12.5%
1/8 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
28.6%
2/7 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
2/4 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
28.6%
2/7 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
1/2 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
40.0%
2/5 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
57.1%
4/7 • Number of events 4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
2/4 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
1/2 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
40.0%
2/5 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
28.6%
2/7 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
2/4 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
37.5%
3/8 • Number of events 4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
12.5%
1/8 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
1/2 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
2/8 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
1/2 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
2/8 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
General disorders
Fatigue
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
2/4 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
37.5%
3/8 • Number of events 3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
General disorders
Asthenia
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
12.5%
1/8 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
General disorders
Chills
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
12.5%
1/8 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
40.0%
2/5 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
37.5%
3/8 • Number of events 3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
40.0%
2/5 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
General disorders
Pyrexia
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
28.6%
2/7 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
75.0%
3/4 • Number of events 3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
4/8 • Number of events 7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
1/2 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
2/8 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
60.0%
3/5 • Number of events 3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
2/4 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
40.0%
2/5 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
2/4 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
37.5%
3/8 • Number of events 3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
40.0%
2/5 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
12.5%
1/8 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
12.5%
1/8 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
2/8 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
12.5%
1/8 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
28.6%
2/7 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
2/4 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
40.0%
2/5 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
2/4 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
12.5%
1/8 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
40.0%
2/5 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
2/4 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
2/8 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
2/4 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
12.5%
1/8 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
12.5%
1/8 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
1/4 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
12.5%
1/8 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
2/8 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
40.0%
2/5 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/8
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/7
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
50.0%
2/4 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
25.0%
2/8 • Number of events 3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
20.0%
1/5 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/5
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
14.3%
1/7 • Number of events 1
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
0.00%
0/4
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
12.5%
1/8 • Number of events 2
AEs were listed and the incidence summarized by study part, assigned dose level. For participants that were escalated within their dose group, AEs were counted for both dose levels. Participants who escalated dose are represented in 2 columns.
|
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