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Trial Outcomes & Findings for A Study for Participants With Advanced Cancer (NCT NCT01214629)

NCT ID: NCT01214629

Last Updated: 2018-08-06

Results Overview

Recommended Phase 2 dose was determined by the maximum tolerated dose (MTD). The MTD was defined as the dose that caused \<1/3 of all participants treated with the study drug to experience a dose-limiting toxicity (DLT). A DLT was defined as an adverse event (AE) occurring during Cycle 1 that fulfilled 1 of the following criteria: Any Common Terminology Criteria for Adverse Events (CTCAE), version (v) 3.0 Grade ≥3 nonhematological toxicity possibly or likely related to the study drug (except for nausea/vomiting/diarrhea without maximal symptomatic/prophylactic treatment); any CTCAE v 3.0 Grade ≥3 thrombocytopenia with bleeding; any CTCAE v3.0 Grade 4 hematological toxicity of \>5 days duration; any febrile neutropenia.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

54 participants

Primary outcome timeframe

Baseline, daily up to 21 days in Cycle 1

Results posted on

2018-08-06

Participant Flow

Participants who completed 2 cycles of treatment are considered having completed study.

Participant milestones

Participant milestones
Measure
0.125 mg/m²/Day LY
0.125 milligrams per meter square per day (mg/m²/day) LY2523355 (LY) was administered as an intravenous (IV) infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until progressive disease (PD), unacceptable toxicity or other withdrawal criterion is met.
0.25 mg/m²/Day LY
0.25 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
0.5 mg/m²/Day LY
0.5 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
1.0 mg/m²/Day LY
1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
2.0 mg/m²/Day LY
2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
5.0 mg/m²/Day LY
5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY + 6 mg PEG
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 milligrams (mg) pegfilgrastim (PEG) was administered subcutaneously (SC) on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY + 6 mg PEG
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
7.0 mg/m²/Day LY + 6 mg PEG
7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
Overall Study
STARTED
1
1
1
3
3
13
5
3
3
18
3
Overall Study
Received at Least 1 Dose of Study Drug
1
1
1
3
3
13
5
3
3
18
3
Overall Study
COMPLETED
0
0
1
1
1
9
4
2
2
11
1
Overall Study
NOT COMPLETED
1
1
0
2
2
4
1
1
1
7
2

Reasons for withdrawal

Reasons for withdrawal
Measure
0.125 mg/m²/Day LY
0.125 milligrams per meter square per day (mg/m²/day) LY2523355 (LY) was administered as an intravenous (IV) infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until progressive disease (PD), unacceptable toxicity or other withdrawal criterion is met.
0.25 mg/m²/Day LY
0.25 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
0.5 mg/m²/Day LY
0.5 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
1.0 mg/m²/Day LY
1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
2.0 mg/m²/Day LY
2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
5.0 mg/m²/Day LY
5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY + 6 mg PEG
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 milligrams (mg) pegfilgrastim (PEG) was administered subcutaneously (SC) on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY + 6 mg PEG
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
7.0 mg/m²/Day LY + 6 mg PEG
7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
Overall Study
Progressive Disease
1
1
0
1
2
3
1
1
1
5
1
Overall Study
Adverse Event
0
0
0
1
0
1
0
0
0
1
0
Overall Study
Physician Decision
0
0
0
0
0
0
0
0
0
0
1
Overall Study
Withdrawal by Subject
0
0
0
0
0
0
0
0
0
1
0

Baseline Characteristics

A Study for Participants With Advanced Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
0.125 mg/m²/Day LY
n=1 Participants
0.125 milligrams per meter square per day (mg/m²/day) LY2523355 (LY) was administered as an intravenous (IV) infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until progressive disease (PD), unacceptable toxicity or other withdrawal criterion is met
0.25 mg/m²/Day LY
n=1 Participants
0.25 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
0.5 mg/m²/Day LY
n=1 Participants
0.5 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
1.0 mg/m²/Day LY
n=3 Participants
1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
2.0 mg/m²/Day LY
n=3 Participants
2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met
4.0 mg/m²/Day LY
n=13 Participants
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
5.0 mg/m²/Day LY
n=5 Participants
5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY
n=3 Participants
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY + 6 mg PEG
n=3 Participants
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 milligrams (mg) pegfilgrastim (PEG) was administered subcutaneously (SC) on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY + 6 mg PEG
n=18 Participants
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
7.0 mg/m²/Day LY + 6 mg PEG
n=3 Participants
7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
Total
n=54 Participants
Total of all reporting groups
Age, Continuous
65.01 years
STANDARD_DEVIATION NA • n=5 Participants
71.20 years
STANDARD_DEVIATION NA • n=7 Participants
52.37 years
STANDARD_DEVIATION NA • n=5 Participants
60.78 years
STANDARD_DEVIATION 12.84 • n=4 Participants
61.30 years
STANDARD_DEVIATION 13.91 • n=21 Participants
59.79 years
STANDARD_DEVIATION 8.75 • n=8 Participants
63.38 years
STANDARD_DEVIATION 12.50 • n=8 Participants
67.26 years
STANDARD_DEVIATION 5.88 • n=24 Participants
66.97 years
STANDARD_DEVIATION 17.19 • n=42 Participants
56.82 years
STANDARD_DEVIATION 12.09 • n=42 Participants
60.13 years
STANDARD_DEVIATION 0.49 • n=42 Participants
60.27 years
STANDARD_DEVIATION 10.78 • n=42 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
3 Participants
n=21 Participants
9 Participants
n=8 Participants
3 Participants
n=8 Participants
1 Participants
n=24 Participants
3 Participants
n=42 Participants
12 Participants
n=42 Participants
2 Participants
n=42 Participants
37 Participants
n=42 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
4 Participants
n=8 Participants
2 Participants
n=8 Participants
2 Participants
n=24 Participants
0 Participants
n=42 Participants
6 Participants
n=42 Participants
1 Participants
n=42 Participants
17 Participants
n=42 Participants
Race/Ethnicity, Customized
African
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
3 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
3 Participants
n=42 Participants
1 Participants
n=42 Participants
9 Participants
n=42 Participants
Race/Ethnicity, Customized
Caucasian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
2 Participants
n=21 Participants
10 Participants
n=8 Participants
5 Participants
n=8 Participants
3 Participants
n=24 Participants
2 Participants
n=42 Participants
10 Participants
n=42 Participants
2 Participants
n=42 Participants
38 Participants
n=42 Participants
Race/Ethnicity, Customized
East Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
Race/Ethnicity, Customized
Hispanic
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
1 Participants
n=42 Participants
3 Participants
n=42 Participants
0 Participants
n=42 Participants
5 Participants
n=42 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
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
2 Participants
n=42 Participants
0 Participants
n=42 Participants
2 Participants
n=42 Participants
Region of Enrollment
United States
1 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
3 Participants
n=21 Participants
13 Participants
n=8 Participants
5 Participants
n=8 Participants
3 Participants
n=24 Participants
3 Participants
n=42 Participants
18 Participants
n=42 Participants
3 Participants
n=42 Participants
54 Participants
n=42 Participants

PRIMARY outcome

Timeframe: Baseline, daily up to 21 days in Cycle 1

Population: All enrolled participants who received at least 1 dose of study drug.

Recommended Phase 2 dose was determined by the maximum tolerated dose (MTD). The MTD was defined as the dose that caused \<1/3 of all participants treated with the study drug to experience a dose-limiting toxicity (DLT). A DLT was defined as an adverse event (AE) occurring during Cycle 1 that fulfilled 1 of the following criteria: Any Common Terminology Criteria for Adverse Events (CTCAE), version (v) 3.0 Grade ≥3 nonhematological toxicity possibly or likely related to the study drug (except for nausea/vomiting/diarrhea without maximal symptomatic/prophylactic treatment); any CTCAE v 3.0 Grade ≥3 thrombocytopenia with bleeding; any CTCAE v3.0 Grade 4 hematological toxicity of \>5 days duration; any febrile neutropenia.

Outcome measures

Outcome measures
Measure
LY2523355
n=30 Participants
0.125 to 6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle)
LY2523355 + Pegfilgrastim
n=24 Participants
4.0 to 7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 with 6 mg pegfilgrastim administered SC on Day 4 of Cycle 1 (21-day Cycle).
0.5 mg/m²/Day LY
0.5 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
1.0 mg/m²/Day LY
1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
2.0 mg/m²/Day LY
2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
5.0 mg/m²/Day LY
5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY + 6 mg PEG
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim (PEG) was administered subcutaneously (SC) on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY + 6 mg PEG
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
7.0 mg/m²/Day LY + 6 mg PEG
7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
Recommended Dose for Phase 2 Studies
4.0 mg/m²/day
6.0 mg/m²/day
—
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Baseline to study completion including 30-day follow-up up to 647 days,any AE reported

Population: All enrolled participants who received at least 1 dose of study drug.

Adverse events (AEs) were considered clinically significant effects. Data presented are the number of participants who experienced serious AEs (SAEs), other non-serious AEs and deaths during the study, including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

Outcome measures

Outcome measures
Measure
LY2523355
n=1 Participants
0.125 to 6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle)
LY2523355 + Pegfilgrastim
n=1 Participants
4.0 to 7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 with 6 mg pegfilgrastim administered SC on Day 4 of Cycle 1 (21-day Cycle).
0.5 mg/m²/Day LY
n=1 Participants
0.5 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
1.0 mg/m²/Day LY
n=3 Participants
1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
2.0 mg/m²/Day LY
n=3 Participants
2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY
n=13 Participants
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
5.0 mg/m²/Day LY
n=5 Participants
5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY
n=3 Participants
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY + 6 mg PEG
n=3 Participants
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim (PEG) was administered subcutaneously (SC) on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY + 6 mg PEG
n=18 Participants
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
7.0 mg/m²/Day LY + 6 mg PEG
n=3 Participants
7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
Number of Participants With Clinically Significant Effects
Death
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Number of Participants With Clinically Significant Effects
SAEs
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
5 Participants
3 Participants
3 Participants
0 Participants
11 Participants
3 Participants
Number of Participants With Clinically Significant Effects
AEs
1 Participants
1 Participants
0 Participants
2 Participants
3 Participants
13 Participants
5 Participants
3 Participants
3 Participants
18 Participants
3 Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 1(21-day cycle):End of infusion (EOI), Day 2: Predose, EOI, Day 3: Predose, EOI, between 1-2 hour EOI, Day 4: anytime, Day 8:anytime, Day 9: anytime, Day 10: anytime

Population: All enrolled participants who received 1 dose of LY2523355 on Day 1 of Cycle 1 with evaluable pharmacokinetic data to enable determination of the LY2523355 plasma Cmax on Day 1 of Cycle 1.

Cmax following a single dose of LY2523355 at each dose level in the presence or absence of pegfilgrastim.

Outcome measures

Outcome measures
Measure
LY2523355
n=3 Participants
0.125 to 6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle)
LY2523355 + Pegfilgrastim
n=3 Participants
4.0 to 7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 with 6 mg pegfilgrastim administered SC on Day 4 of Cycle 1 (21-day Cycle).
0.5 mg/m²/Day LY
n=16 Participants
0.5 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
1.0 mg/m²/Day LY
n=5 Participants
1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
2.0 mg/m²/Day LY
n=21 Participants
2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY
n=3 Participants
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
5.0 mg/m²/Day LY
5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY + 6 mg PEG
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim (PEG) was administered subcutaneously (SC) on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY + 6 mg PEG
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
7.0 mg/m²/Day LY + 6 mg PEG
7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2523355 Following A Single Dose
32.6 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 36
61.7 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 10
120 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 40
127 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 28
168 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 39
222 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 33
—
—
—
—
—

SECONDARY outcome

Timeframe: Cycle 1, Day 3(21-day cycle): End of infusion

Population: All enrolled participants who received more than 1 dose of LY2523355 and had evaluable pharmacokinetic data to enable determination of the LY2523355 Cmax on Day 3 of Cycle 1.

Cmax following multiple doses of LY2523355 at each dose level in the presence or absence of pegfilgrastim.

Outcome measures

Outcome measures
Measure
LY2523355
n=3 Participants
0.125 to 6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle)
LY2523355 + Pegfilgrastim
n=3 Participants
4.0 to 7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 with 6 mg pegfilgrastim administered SC on Day 4 of Cycle 1 (21-day Cycle).
0.5 mg/m²/Day LY
n=16 Participants
0.5 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
1.0 mg/m²/Day LY
n=5 Participants
1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
2.0 mg/m²/Day LY
n=20 Participants
2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY
n=3 Participants
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
5.0 mg/m²/Day LY
5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY + 6 mg PEG
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim (PEG) was administered subcutaneously (SC) on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY + 6 mg PEG
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
7.0 mg/m²/Day LY + 6 mg PEG
7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
Pharmacokinetics: Plasma Cmax of LY2523355 Following Multiple Doses
29.8 ng/mL
Geometric Coefficient of Variation 32
73.6 ng/mL
Geometric Coefficient of Variation 47
126 ng/mL
Geometric Coefficient of Variation 49
129 ng/mL
Geometric Coefficient of Variation 34
193 ng/mL
Geometric Coefficient of Variation 37
231 ng/mL
Geometric Coefficient of Variation 23
—
—
—
—
—

SECONDARY outcome

Timeframe: Cycle 1,Day 1(21-day cycle): End of infusion (EOI), Day 2: Predose, EOI, Day 3: Predose, EOI, between 1-2 hour EOI, Day 4: anytime, Day 8:anytime, Day 9: anytime, Day 10: anytime

Population: All enrolled participants who received 1 dose of LY2523355 on Day 1 of Cycle 1 with evaluable pharmacokinetic data to enable calculation of the LY2523355 AUC(0-∞) on Day 1 of Cycle 1.

AUC(0-∞) following a single dose of LY2523355 at each dose level in the presence or absence of pegfilgrastim.

Outcome measures

Outcome measures
Measure
LY2523355
n=3 Participants
0.125 to 6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle)
LY2523355 + Pegfilgrastim
n=3 Participants
4.0 to 7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 with 6 mg pegfilgrastim administered SC on Day 4 of Cycle 1 (21-day Cycle).
0.5 mg/m²/Day LY
n=16 Participants
0.5 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
1.0 mg/m²/Day LY
n=5 Participants
1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
2.0 mg/m²/Day LY
n=21 Participants
2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY
n=3 Participants
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
5.0 mg/m²/Day LY
5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY + 6 mg PEG
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim (PEG) was administered subcutaneously (SC) on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY + 6 mg PEG
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
7.0 mg/m²/Day LY + 6 mg PEG
7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2523355 Following A Single Dose
81.8 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 33
159 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 21
324 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 41
379 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 23
443 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 40
642 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 50
—
—
—
—
—

SECONDARY outcome

Timeframe: Cycle 1, Day 3(21-day cycle): End of infusion

Population: All enrolled participants who received more than 1 dose of LY2523355 and had evaluable pharmacokinetic data to enable calculation of the LY2523355 AUC(0-∞) on Day 3 of Cycle 1.

AUC(0-∞) following multiple doses of LY2523355 at each dose level in the presence or absence of pegfilgrastim.

Outcome measures

Outcome measures
Measure
LY2523355
n=3 Participants
0.125 to 6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle)
LY2523355 + Pegfilgrastim
n=3 Participants
4.0 to 7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 with 6 mg pegfilgrastim administered SC on Day 4 of Cycle 1 (21-day Cycle).
0.5 mg/m²/Day LY
n=16 Participants
0.5 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
1.0 mg/m²/Day LY
n=5 Participants
1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
2.0 mg/m²/Day LY
n=20 Participants
2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY
n=3 Participants
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
5.0 mg/m²/Day LY
5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY + 6 mg PEG
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim (PEG) was administered subcutaneously (SC) on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY + 6 mg PEG
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
7.0 mg/m²/Day LY + 6 mg PEG
7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
Pharmacokinetics: AUC(0-∞) of LY2523355 Following Multiple Doses
109 ng*h/mL
Geometric Coefficient of Variation 19
220 ng*h/mL
Geometric Coefficient of Variation 30
484 ng*h/mL
Geometric Coefficient of Variation 46
593 ng*h/mL
Geometric Coefficient of Variation 45
649 ng*h/mL
Geometric Coefficient of Variation 52
1090 ng*h/mL
Geometric Coefficient of Variation 54
—
—
—
—
—

SECONDARY outcome

Timeframe: Baseline to measured disease progression or discontinuation up to 617 days

Population: All enrolled participants who received at least 1 dose of study drug.

Data presented are the number of participants with a confirmed complete response (CR) or partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions. PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions.

Outcome measures

Outcome measures
Measure
LY2523355
n=1 Participants
0.125 to 6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle)
LY2523355 + Pegfilgrastim
n=1 Participants
4.0 to 7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 with 6 mg pegfilgrastim administered SC on Day 4 of Cycle 1 (21-day Cycle).
0.5 mg/m²/Day LY
n=1 Participants
0.5 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
1.0 mg/m²/Day LY
n=3 Participants
1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
2.0 mg/m²/Day LY
n=3 Participants
2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY
n=13 Participants
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
5.0 mg/m²/Day LY
n=5 Participants
5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY
n=3 Participants
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY + 6 mg PEG
n=3 Participants
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim (PEG) was administered subcutaneously (SC) on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY + 6 mg PEG
n=18 Participants
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
7.0 mg/m²/Day LY + 6 mg PEG
n=3 Participants
7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
Number of Participants With Tumor Response
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
1 Participants
0 Participants

Adverse Events

0.125 mg/m²/Day LY

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

0.25 mg/m²/Day LY

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

0.5 mg/m²/Day LY

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

1.0 mg/m²/Day LY

Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths

2.0 mg/m²/Day LY

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

4.0 mg/m²/Day LY

Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths

4.0 mg/m²/Day LY + 6 mg PEG

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

5.0 mg/m²/Day LY

Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths

6.0 mg/m²/Day LY

Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths

6.0 mg/m²/Day LY + 6 mg PEG

Serious events: 11 serious events
Other events: 18 other events
Deaths: 0 deaths

7.0 mg/m²/Day LY + 6 mg PEG

Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
0.125 mg/m²/Day LY
n=1 participants at risk
0.125 mg/m²/day LY2523355 (LY) was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
0.25 mg/m²/Day LY
n=1 participants at risk
0.25 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
0.5 mg/m²/Day LY
n=1 participants at risk
0.5 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
1.0 mg/m²/Day LY
n=3 participants at risk
1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
2.0 mg/m²/Day LY
n=3 participants at risk
2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY
n=13 participants at risk
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY + 6 mg PEG
n=3 participants at risk
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 milligrams (mg) pegfilgrastim (PEG) was administered subcutaneously (SC) on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
5.0 mg/m²/Day LY
n=5 participants at risk
5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY
n=3 participants at risk
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY + 6 mg PEG
n=18 participants at risk
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
7.0 mg/m²/Day LY + 6 mg PEG
n=3 participants at risk
7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
15.4%
2/13 • Number of events 2
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
33.3%
1/3 • Number of events 1
Blood and lymphatic system disorders
Leukopenia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
100.0%
3/3 • Number of events 3
0.00%
0/18
0.00%
0/3
Blood and lymphatic system disorders
Neutropenia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
40.0%
2/5 • Number of events 2
0.00%
0/3
0.00%
0/18
0.00%
0/3
Cardiac disorders
Atrial fibrillation
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Blood and lymphatic system disorders
Anaemia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Gastrointestinal disorders
Abdominal pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
0.00%
0/18
0.00%
0/3
Gastrointestinal disorders
Diarrhoea
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
33.3%
1/3 • Number of events 1
0.00%
0/18
33.3%
1/3 • Number of events 1
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
11.1%
2/18 • Number of events 2
0.00%
0/3
Gastrointestinal disorders
Ileus
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Gastrointestinal disorders
Nausea
0.00%
0/1
0.00%
0/1
0.00%
0/1
33.3%
1/3 • Number of events 1
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
0.00%
0/18
0.00%
0/3
Gastrointestinal disorders
Oesophageal ulcer
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Gastrointestinal disorders
Vomiting
0.00%
0/1
0.00%
0/1
0.00%
0/1
33.3%
1/3 • Number of events 1
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
0.00%
0/18
0.00%
0/3
General disorders
Chest pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
General disorders
Mucosal inflammation
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
33.3%
1/3 • Number of events 1
General disorders
Pyrexia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
16.7%
3/18 • Number of events 3
0.00%
0/3
Infections and infestations
Infection
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
66.7%
2/3 • Number of events 2
0.00%
0/18
0.00%
0/3
Infections and infestations
Neutropenic infection
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
0.00%
0/18
0.00%
0/3
Infections and infestations
Pneumonia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
11.1%
2/18 • Number of events 2
0.00%
0/3
Infections and infestations
Sepsis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Investigations
International normalised ratio increased
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Metabolism and nutrition disorders
Failure to thrive
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
0.00%
0/18
0.00%
0/3
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
33.3%
1/3 • Number of events 1
0.00%
0/18
33.3%
1/3 • Number of events 1
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Nervous system disorders
Cerebrovascular accident
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
33.3%
1/3 • Number of events 1
Nervous system disorders
Convulsion
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
0.00%
0/18
0.00%
0/3
Nervous system disorders
Headache
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Renal and urinary disorders
Hydronephrosis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Renal and urinary disorders
Renal tubular necrosis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Hypoventilation
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3

Other adverse events

Other adverse events
Measure
0.125 mg/m²/Day LY
n=1 participants at risk
0.125 mg/m²/day LY2523355 (LY) was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
0.25 mg/m²/Day LY
n=1 participants at risk
0.25 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
0.5 mg/m²/Day LY
n=1 participants at risk
0.5 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
1.0 mg/m²/Day LY
n=3 participants at risk
1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
2.0 mg/m²/Day LY
n=3 participants at risk
2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY
n=13 participants at risk
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
4.0 mg/m²/Day LY + 6 mg PEG
n=3 participants at risk
4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 milligrams (mg) pegfilgrastim (PEG) was administered subcutaneously (SC) on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
5.0 mg/m²/Day LY
n=5 participants at risk
5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY
n=3 participants at risk
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
6.0 mg/m²/Day LY + 6 mg PEG
n=18 participants at risk
6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
7.0 mg/m²/Day LY + 6 mg PEG
n=3 participants at risk
7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. 6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 2
0.00%
0/3
Blood and lymphatic system disorders
Anaemia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
38.5%
5/13 • Number of events 5
0.00%
0/3
40.0%
2/5 • Number of events 2
33.3%
1/3 • Number of events 1
33.3%
6/18 • Number of events 7
0.00%
0/3
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 2
0.00%
0/3
0.00%
0/18
0.00%
0/3
Blood and lymphatic system disorders
Haemolysis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
0.00%
0/18
0.00%
0/3
Blood and lymphatic system disorders
Leukopenia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
61.5%
8/13 • Number of events 12
33.3%
1/3 • Number of events 2
100.0%
5/5 • Number of events 8
0.00%
0/3
27.8%
5/18 • Number of events 7
0.00%
0/3
Blood and lymphatic system disorders
Lymphopenia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
33.3%
1/3 • Number of events 1
38.5%
5/13 • Number of events 7
0.00%
0/3
20.0%
1/5 • Number of events 1
33.3%
1/3 • Number of events 1
22.2%
4/18 • Number of events 8
0.00%
0/3
Blood and lymphatic system disorders
Neutropenia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
53.8%
7/13 • Number of events 11
0.00%
0/3
60.0%
3/5 • Number of events 4
0.00%
0/3
38.9%
7/18 • Number of events 9
33.3%
1/3 • Number of events 1
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
11.1%
2/18 • Number of events 3
0.00%
0/3
Cardiac disorders
Arrhythmia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Cardiac disorders
Atrial fibrillation
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Cardiac disorders
Atrial tachycardia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Cardiac disorders
Palpitations
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
33.3%
1/3 • Number of events 1
0.00%
0/5
0.00%
0/3
11.1%
2/18 • Number of events 3
0.00%
0/3
Cardiac disorders
Sinus arrhythmia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Cardiac disorders
Sinus bradycardia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 2
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Cardiac disorders
Sinus tachycardia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
11.1%
2/18 • Number of events 4
0.00%
0/3
Cardiac disorders
Tachycardia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
33.3%
1/3 • Number of events 1
5.6%
1/18 • Number of events 1
0.00%
0/3
Ear and labyrinth disorders
Ear pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
33.3%
1/3 • Number of events 1
0.00%
0/18
0.00%
0/3
Eye disorders
Cataract
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
0.00%
0/18
0.00%
0/3
Eye disorders
Eye irritation
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
33.3%
1/3 • Number of events 1
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Gastrointestinal disorders
Abdominal pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Gastrointestinal disorders
Anal inflammation
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Gastrointestinal disorders
Anorectal discomfort
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
11.1%
2/18 • Number of events 2
0.00%
0/3
Gastrointestinal disorders
Ascites
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Gastrointestinal disorders
Cheilitis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
11.1%
2/18 • Number of events 2
0.00%
0/3
Gastrointestinal disorders
Constipation
100.0%
1/1 • Number of events 1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
23.1%
3/13 • Number of events 4
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
22.2%
4/18 • Number of events 4
33.3%
1/3 • Number of events 1
Gastrointestinal disorders
Diarrhoea
0.00%
0/1
100.0%
1/1 • Number of events 1
0.00%
0/1
0.00%
0/3
0.00%
0/3
30.8%
4/13 • Number of events 4
0.00%
0/3
20.0%
1/5 • Number of events 1
33.3%
1/3 • Number of events 1
33.3%
6/18 • Number of events 6
0.00%
0/3
Gastrointestinal disorders
Dyspepsia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
16.7%
3/18 • Number of events 3
0.00%
0/3
Gastrointestinal disorders
Dysphagia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
11.1%
2/18 • Number of events 2
0.00%
0/3
Gastrointestinal disorders
Flatulence
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Gastrointestinal disorders
Food poisoning
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Gastrointestinal disorders
Gastritis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Gastrointestinal disorders
Melaena
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Gastrointestinal disorders
Nausea
0.00%
0/1
0.00%
0/1
0.00%
0/1
33.3%
1/3 • Number of events 1
33.3%
1/3 • Number of events 1
46.2%
6/13 • Number of events 7
0.00%
0/3
0.00%
0/5
0.00%
0/3
33.3%
6/18 • Number of events 8
66.7%
2/3 • Number of events 2
Gastrointestinal disorders
Proctalgia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
15.4%
2/13 • Number of events 2
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Gastrointestinal disorders
Stomatitis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
40.0%
2/5 • Number of events 2
66.7%
2/3 • Number of events 2
33.3%
6/18 • Number of events 7
66.7%
2/3 • Number of events 2
Gastrointestinal disorders
Vomiting
0.00%
0/1
0.00%
0/1
0.00%
0/1
33.3%
1/3 • Number of events 2
0.00%
0/3
30.8%
4/13 • Number of events 4
0.00%
0/3
40.0%
2/5 • Number of events 2
0.00%
0/3
38.9%
7/18 • Number of events 12
33.3%
1/3 • Number of events 2
General disorders
Asthenia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
General disorders
Axillary pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
General disorders
Chest discomfort
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
33.3%
1/3 • Number of events 1
0.00%
0/13
33.3%
1/3 • Number of events 1
20.0%
1/5 • Number of events 1
0.00%
0/3
0.00%
0/18
0.00%
0/3
General disorders
Chest pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
16.7%
3/18 • Number of events 3
0.00%
0/3
General disorders
Chills
0.00%
0/1
100.0%
1/1 • Number of events 1
0.00%
0/1
0.00%
0/3
0.00%
0/3
15.4%
2/13 • Number of events 3
33.3%
1/3 • Number of events 1
20.0%
1/5 • Number of events 1
33.3%
1/3 • Number of events 1
22.2%
4/18 • Number of events 5
0.00%
0/3
General disorders
Early satiety
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
33.3%
1/3 • Number of events 1
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
General disorders
Fatigue
0.00%
0/1
100.0%
1/1 • Number of events 1
0.00%
0/1
0.00%
0/3
0.00%
0/3
46.2%
6/13 • Number of events 6
33.3%
1/3 • Number of events 1
40.0%
2/5 • Number of events 2
0.00%
0/3
38.9%
7/18 • Number of events 7
33.3%
1/3 • Number of events 1
General disorders
Feeling hot
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
General disorders
Gait disturbance
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
33.3%
1/3 • Number of events 1
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
0.00%
0/18
0.00%
0/3
General disorders
Local swelling
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
General disorders
Mucosal inflammation
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
11.1%
2/18 • Number of events 3
0.00%
0/3
General disorders
Nodule
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
33.3%
1/3 • Number of events 1
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
General disorders
Oedema
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
General disorders
Oedema peripheral
0.00%
0/1
0.00%
0/1
0.00%
0/1
33.3%
1/3 • Number of events 1
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
33.3%
1/3 • Number of events 1
16.7%
3/18 • Number of events 4
0.00%
0/3
General disorders
Pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
16.7%
3/18 • Number of events 3
0.00%
0/3
General disorders
Pyrexia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
66.7%
2/3 • Number of events 2
27.8%
5/18 • Number of events 8
0.00%
0/3
Hepatobiliary disorders
Bile duct obstruction
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Infections and infestations
Bacterial sepsis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Infections and infestations
Candidiasis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Infections and infestations
Cellulitis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Infections and infestations
Fungal infection
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Infections and infestations
Nasopharyngitis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
66.7%
2/3 • Number of events 2
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Infections and infestations
Oral candidiasis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Infections and infestations
Oral herpes
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Infections and infestations
Skin infection
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
0.00%
0/18
0.00%
0/3
Infections and infestations
Tooth infection
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Infections and infestations
Upper respiratory tract infection
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Infections and infestations
Urinary tract infection
0.00%
0/1
0.00%
0/1
0.00%
0/1
33.3%
1/3 • Number of events 1
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
11.1%
2/18 • Number of events 4
0.00%
0/3
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Injury, poisoning and procedural complications
Radius fracture
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Injury, poisoning and procedural complications
Rib fracture
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Injury, poisoning and procedural complications
Thermal burn
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Investigations
Activated partial thromboplastin time prolonged
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Investigations
Alanine aminotransferase increased
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
33.3%
1/3 • Number of events 1
Investigations
Aspartate aminotransferase increased
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 2
33.3%
1/3 • Number of events 1
Investigations
Blood alkaline phosphatase
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 2
0.00%
0/3
Investigations
Blood alkaline phosphatase increased
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Investigations
Blood bilirubin increased
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Investigations
Blood chloride increased
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Investigations
Blood creatinine
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 4
0.00%
0/3
Investigations
Blood creatinine decreased
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 2
0.00%
0/3
Investigations
Blood creatinine increased
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Investigations
Blood uric acid decreased
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Investigations
Gamma-glutamyltransferase increased
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Investigations
Haemoglobin
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Investigations
Haemoglobin decreased
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
33.3%
1/3 • Number of events 1
0.00%
0/18
33.3%
1/3 • Number of events 1
Investigations
International normalised ratio decreased
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Investigations
International normalised ratio increased
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Investigations
Neutrophil count increased
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
11.1%
2/18 • Number of events 5
0.00%
0/3
Investigations
Platelet count
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 3
0.00%
0/3
Investigations
Platelet count decreased
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
11.1%
2/18 • Number of events 2
0.00%
0/3
Investigations
Prothrombin time prolonged
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Investigations
Weight decreased
0.00%
0/1
100.0%
1/1 • Number of events 1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
33.3%
1/3 • Number of events 1
20.0%
1/5 • Number of events 1
33.3%
1/3 • Number of events 1
11.1%
2/18 • Number of events 2
33.3%
1/3 • Number of events 1
Investigations
Weight increased
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Investigations
White blood cell count decreased
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
33.3%
1/3 • Number of events 1
Investigations
White blood cell count increased
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
22.2%
4/18 • Number of events 6
0.00%
0/3
Metabolism and nutrition disorders
Decreased appetite
100.0%
1/1 • Number of events 1
100.0%
1/1 • Number of events 1
0.00%
0/1
33.3%
1/3 • Number of events 1
33.3%
1/3 • Number of events 1
15.4%
2/13 • Number of events 2
0.00%
0/3
40.0%
2/5 • Number of events 2
0.00%
0/3
27.8%
5/18 • Number of events 5
0.00%
0/3
Metabolism and nutrition disorders
Dehydration
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
33.3%
1/3 • Number of events 1
27.8%
5/18 • Number of events 5
33.3%
1/3 • Number of events 1
Metabolism and nutrition disorders
Hypercholesterolaemia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
15.4%
2/13 • Number of events 2
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
33.3%
1/3 • Number of events 1
20.0%
1/5 • Number of events 1
0.00%
0/3
16.7%
3/18 • Number of events 5
0.00%
0/3
Metabolism and nutrition disorders
Hyperuricaemia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
16.7%
3/18 • Number of events 6
0.00%
0/3
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/1
0.00%
0/1
0.00%
0/1
33.3%
1/3 • Number of events 1
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 2
0.00%
0/3
22.2%
4/18 • Number of events 4
0.00%
0/3
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
33.3%
6/18 • Number of events 8
0.00%
0/3
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
11.1%
2/18 • Number of events 6
0.00%
0/3
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
33.3%
1/3 • Number of events 1
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 4
0.00%
0/3
Metabolism and nutrition disorders
Hypophosphataemia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
22.2%
4/18 • Number of events 4
0.00%
0/3
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
33.3%
1/3 • Number of events 1
0.00%
0/5
0.00%
0/3
16.7%
3/18 • Number of events 3
0.00%
0/3
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Musculoskeletal and connective tissue disorders
Groin pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 2
0.00%
0/3
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
11.1%
2/18 • Number of events 4
0.00%
0/3
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
11.1%
2/18 • Number of events 2
0.00%
0/3
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
33.3%
1/3 • Number of events 1
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
15.4%
2/13 • Number of events 3
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
11.1%
2/18 • Number of events 2
0.00%
0/3
Musculoskeletal and connective tissue disorders
Pain in jaw
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
33.3%
1/3 • Number of events 1
0.00%
0/18
0.00%
0/3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Nervous system disorders
Ataxia
0.00%
0/1
0.00%
0/1
0.00%
0/1
33.3%
1/3 • Number of events 1
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Nervous system disorders
Dizziness
0.00%
0/1
0.00%
0/1
0.00%
0/1
33.3%
1/3 • Number of events 1
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
16.7%
3/18 • Number of events 5
0.00%
0/3
Nervous system disorders
Dysgeusia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
33.3%
1/3 • Number of events 1
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Nervous system disorders
Headache
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
33.3%
1/3 • Number of events 1
0.00%
0/5
0.00%
0/3
11.1%
2/18 • Number of events 2
0.00%
0/3
Nervous system disorders
Paraesthesia
0.00%
0/1
0.00%
0/1
0.00%
0/1
33.3%
1/3 • Number of events 1
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
11.1%
2/18 • Number of events 2
0.00%
0/3
Nervous system disorders
Sciatica
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Nervous system disorders
Sinus headache
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Nervous system disorders
Somnolence
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Nervous system disorders
Viith nerve paralysis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
33.3%
1/3 • Number of events 1
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Psychiatric disorders
Agitation
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Psychiatric disorders
Anxiety
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Psychiatric disorders
Confusional state
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Psychiatric disorders
Depression
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
11.1%
2/18 • Number of events 2
0.00%
0/3
Psychiatric disorders
Insomnia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
0.00%
0/18
0.00%
0/3
Psychiatric disorders
Mental status changes
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Renal and urinary disorders
Dysuria
0.00%
0/1
0.00%
0/1
0.00%
0/1
33.3%
1/3 • Number of events 1
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
33.3%
1/3 • Number of events 1
0.00%
0/18
0.00%
0/3
Renal and urinary disorders
Haematuria
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Renal and urinary disorders
Haemoglobinuria
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
0.00%
0/18
0.00%
0/3
Renal and urinary disorders
Micturition urgency
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 2
0.00%
0/3
Renal and urinary disorders
Pollakiuria
100.0%
1/1 • Number of events 1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
33.3%
1/3 • Number of events 1
5.6%
1/18 • Number of events 1
33.3%
1/3 • Number of events 1
Reproductive system and breast disorders
Breast pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Reproductive system and breast disorders
Genital discomfort
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
33.3%
1/3 • Number of events 1
Reproductive system and breast disorders
Perineal pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
33.3%
1/3 • Number of events 1
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
11.1%
2/18 • Number of events 2
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
33.3%
1/3 • Number of events 1
0.00%
0/13
33.3%
1/3 • Number of events 1
20.0%
1/5 • Number of events 1
0.00%
0/3
5.6%
1/18 • Number of events 2
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
33.3%
1/3 • Number of events 1
5.6%
1/18 • Number of events 1
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
66.7%
2/3 • Number of events 2
5.6%
1/18 • Number of events 1
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
0.00%
0/3
0.00%
0/18
0.00%
0/3
Respiratory, thoracic and mediastinal disorders
Throat irritation
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
20.0%
1/5 • Number of events 1
33.3%
1/3 • Number of events 1
27.8%
5/18 • Number of events 5
33.3%
1/3 • Number of events 1
Skin and subcutaneous tissue disorders
Dermatitis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Skin and subcutaneous tissue disorders
Exfoliative rash
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Skin and subcutaneous tissue disorders
Hair growth abnormal
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Skin and subcutaneous tissue disorders
Hyperkeratosis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
33.3%
1/3 • Number of events 1
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
0.00%
0/3
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/1
100.0%
1/1 • Number of events 1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
33.3%
1/3 • Number of events 1
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
23.1%
3/13 • Number of events 3
0.00%
0/3
0.00%
0/5
0.00%
0/3
22.2%
4/18 • Number of events 4
33.3%
1/3 • Number of events 1
Skin and subcutaneous tissue disorders
Rash
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
7.7%
1/13 • Number of events 1
0.00%
0/3
40.0%
2/5 • Number of events 2
33.3%
1/3 • Number of events 1
27.8%
5/18 • Number of events 7
0.00%
0/3
Skin and subcutaneous tissue disorders
Skin chapped
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
0.00%
0/18
33.3%
1/3 • Number of events 1
Skin and subcutaneous tissue disorders
Skin discolouration
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Surgical and medical procedures
Tooth extraction
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Vascular disorders
Hot flush
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
16.7%
3/18 • Number of events 3
0.00%
0/3
Vascular disorders
Hypertension
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3
Vascular disorders
Hypotension
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
33.3%
1/3 • Number of events 1
40.0%
2/5 • Number of events 2
0.00%
0/3
22.2%
4/18 • Number of events 5
0.00%
0/3
Vascular disorders
Thrombosis
0.00%
0/1
0.00%
0/1
0.00%
0/1
0.00%
0/3
0.00%
0/3
0.00%
0/13
0.00%
0/3
0.00%
0/5
0.00%
0/3
5.6%
1/18 • Number of events 1
0.00%
0/3

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