Trial Outcomes & Findings for Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors (NCT NCT02318329)

NCT ID: NCT02318329

Last Updated: 2024-06-04

Results Overview

Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs)

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 79 participants
• Primary outcome timeframe: 4 weeks on average
• Results posted on: 2024-06-04

Participant Flow

Participant milestones

Measure	Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 3.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.	Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 6.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.	Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 10 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.	Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 15 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.	Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg Part 1B will be a 3 + 3 design and enroll patients with gastric cancer. Participants may be gastric cancer patients whose tumors will be tested retrospectively, or those who are known to be FGFR2 gene-amplified or FGFR2b protein-overexpressed. In a staggered fashion with Part 1A dose escalation, patients in Part 1B will be enrolled one dose level below the current highest dose level cohort being studied in Part 1A. Dose: 6.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.	Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 1mg/kg A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 1.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.	Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg Part 1B will be a 3 + 3 design and enroll patients with gastric cancer. Participants may be gastric cancer patients whose tumors will be tested retrospectively, or those who are known to be FGFR2 gene-amplified or FGFR2b protein-overexpressed. In a staggered fashion with Part 1A dose escalation, patients in Part 1B will be enrolled one dose level below the current highest dose level cohort being studied in Part 1A. Dose: 10 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.	Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.
Overall Study STARTED	3	3	3	3	1	1	3	4	6	52
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	3	3	3	3	1	1	3	4	6	52

Reasons for withdrawal

Measure	Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 3.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.	Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 6.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.	Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 10 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.	Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 15 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.	Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg Part 1B will be a 3 + 3 design and enroll patients with gastric cancer. Participants may be gastric cancer patients whose tumors will be tested retrospectively, or those who are known to be FGFR2 gene-amplified or FGFR2b protein-overexpressed. In a staggered fashion with Part 1A dose escalation, patients in Part 1B will be enrolled one dose level below the current highest dose level cohort being studied in Part 1A. Dose: 6.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.	Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 1mg/kg A traditional 3 + 3 dose escalation design will be implemented. Successive cohorts of patients (3/cohort) will each be started on a fixed dose of FPA144. Dose: 1.0 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.	Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg Part 1B will be a 3 + 3 design and enroll patients with gastric cancer. Participants may be gastric cancer patients whose tumors will be tested retrospectively, or those who are known to be FGFR2 gene-amplified or FGFR2b protein-overexpressed. In a staggered fashion with Part 1A dose escalation, patients in Part 1B will be enrolled one dose level below the current highest dose level cohort being studied in Part 1A. Dose: 10 mg/kg FPA144 every 2 weeks in 28 day cycles for this cohort.	Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.
Overall Study Progressive Disease	2	3	3	3	1	1	2	3	5	39
Overall Study Death	0	0	0	0	0	0	0	0	0	5
Overall Study Lost to Follow-up	0	0	0	0	0	0	0	0	0	1
Overall Study Withdrawal by Subject	0	0	0	0	0	0	0	0	0	6
Overall Study Other	1	0	0	0	0	0	1	1	1	1

Baseline Characteristics

Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors

Baseline characteristics by cohort

Measure	Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg n=4 Participants 3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles..	Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg n=1 Participants 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric 6 mg/kg n=1 Participants 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric 10 mg/kg n=6 Participants 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 15 mg/kg IV every 2 weeks in 28 day cycles.	Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors n=52 Participants Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.	Total n=79 Participants Total of all reporting groups
Age, Customized	74 years n=5 Participants	64.5 years n=7 Participants	63 years n=5 Participants	62 years n=4 Participants	64 years n=21 Participants	59 years n=8 Participants	54 years n=8 Participants	39 years n=24 Participants	52 years n=42 Participants	57 years n=42 Participants	59 years n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants	21 Participants n=42 Participants	33 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants	31 Participants n=42 Participants	46 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) 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	1 Participants n=8 Participants	1 Participants n=24 Participants	5 Participants n=42 Participants	39 Participants n=42 Participants	46 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African 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	1 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	11 Participants n=42 Participants	31 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Region of Enrollment South Korea	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	1 participants n=8 Participants	1 participants n=24 Participants	5 participants n=42 Participants	33 participants n=42 Participants	40 participants n=42 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants	3 participants n=21 Participants	3 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	1 participants n=42 Participants	14 participants n=42 Participants	34 participants n=42 Participants
Region of Enrollment Taiwan	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	5 participants n=42 Participants	5 participants n=42 Participants

PRIMARY outcome

Timeframe: 4 weeks on average

Population: All patients who received FPA144

Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs)

Outcome measures

Measure	Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg n=4 Participants 3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg n=1 Participants 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg n=1 Participants 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg n=6 Participants 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles.	Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.
Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only).	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: 16 weeks on average

Population: All patients who received FPA144

Number of Participants with AEs and clinical laboratory abnormalities (Parts 1B and 2 only)

Outcome measures

Measure	Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg n=1 Participants 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg n=1 Participants 3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg n=6 Participants 3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg n=52 Participants 3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg 3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg 3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles.	Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.
Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only)	1 Participants	1 Participants	6 Participants	48 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 16 weeks on average

Population: All patients in the PK Full Analysis Population who have sufficient PK samples for the calculation of at least one PK parameter on at least one Study Day. Dose normalized PK parameters were reported so that patients at 0.3 mg/kg were excluded from mean value for part 1a because it is in the non-linear dose range.

Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2.

• Summary of area under serum concentration-time curve, maximum serum concentration,

Outcome measures

Measure	Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg n=4 Participants 3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg n=1 Participants 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg n=1 Participants 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg n=5 Participants 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles.	Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors n=49 Participants Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.
Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration	—	0.2483 ug/ml Standard Deviation 0.08763	0.3117 ug/ml Standard Deviation 0.06536	0.2873 ug/ml Standard Deviation 0.02793	0.4097 ug/ml Standard Deviation 0.03208	0.3847 ug/ml Standard Deviation 0.14931	0.4900 ug/ml Standard Deviation 0	0.232 ug/ml Standard Deviation 0	0.2990 ug/ml Standard Deviation 0.06690	0.3145 ug/ml Standard Deviation 0.06981

SECONDARY outcome

Timeframe: 16 weeks on average

Population: Patients with various levels of FGFR2b overexpression in tumor samples treated with bemarituzumab who had baseline and post baseline scans performed.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg n=4 Participants 3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg n=1 Participants 3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg n=1 Participants 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg n=1 Participants 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg n=6 Participants 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles.	Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors n=49 Participants Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	4 Participants

SECONDARY outcome

Timeframe: 16 weeks on average

Population: Gastric cancer patients with various levels of FGFR2b overexpression treated with FPA144 who had an objective response.

Duration of complete or partial response with 95% confidence intervals in gastric cancer population.

Outcome measures

Measure	Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg n=6 Participants 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg 3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg 3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg 3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg 3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg 3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles.	Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.
Duration of Response Per RECIST 1.1 (Part 2 Only)	14.1 Weeks Interval 9.1 to 19.1	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 16 weeks on average

Population: All patients in the PK Full Analysis Population who have sufficient PK samples for the calculation of at least one PK parameter on at least one Study Day. Dose normalized PK parameters were reported so that patients at 0.3 mg/kg were excluded from mean value for part 1a because it is in the non-linear dose range.

Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2.

• Summary of area under serum concentration-time curve, maximum serum concentration,

Outcome measures

Measure	Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 1 mg/kg n=4 Participants 3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 3 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 6 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg n=3 Participants 3 + 3 dose escalation cohort with 15 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 3mg/kg n=1 Participants 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg n=1 Participants 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg n=3 Participants 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles.	Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors n=49 Participants Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.
Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve	—	1.288 ug*day/ml Standard Deviation 0.5159	1.547 ug*day/ml Standard Deviation 0.2902	1.427 ug*day/ml Standard Deviation 0.2367	1.863 ug*day/ml Standard Deviation 0.4119	1.697 ug*day/ml Standard Deviation 0.1464	2.69 ug*day/ml Standard Deviation 0	1.59 ug*day/ml Standard Deviation 0	1.648 ug*day/ml Standard Deviation 0.4055	1.867 ug*day/ml Standard Deviation 0.4495

Adverse Events

Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1A: FPA144 Dose Escalation Solid Tumors 1.0 mg/kg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 1A: FPA144 Dose Escalation Solid Tumors 3.0 mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1A: FPA144 Dose Escalation Solid Tumors 6.0 mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors

Serious events: 17 serious events

Other events: 48 other events

Deaths: 5 deaths

Serious adverse events

Measure	Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg n=3 participants at risk 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 1.0 mg/kg n=4 participants at risk 3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 3.0 mg/kg n=3 participants at risk 3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 6.0 mg/kg n=3 participants at risk 3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg n=3 participants at risk 3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg n=3 participants at risk 3 + 3 dose escalation cohort with 15mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg n=1 participants at risk 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles	Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg n=1 participants at risk 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles	Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg n=6 participants at risk 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles	Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors n=52 participants at risk Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.
Gastrointestinal disorders Gastrointestinal Hemorrhage	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Infections and infestations Liver Abscess	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Abdominal Pain, Upper	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Eye disorders Limbal stem cell deficiency	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Nausea	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Ileus	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Hemorrhoids	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Duodenal Perforation	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
General disorders Pain	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Infections and infestations Septic Shock	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Infections and infestations Arthritis bacterial	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Infections and infestations Psoas Abscess	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Renal and urinary disorders Azotemia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Renal and urinary disorders urinary tract obstruction	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Eye disorders Ulcerative Keratitis	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Hemorrhage	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Congenital, familial and genetic disorders Corneal Dystrophy	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Injury, poisoning and procedural complications Infusion Reaction	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Ascites	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Large intestinal Obstruction	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
General disorders Pyrexia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Infections and infestations Sepsis	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
General disorders Device Malfunction	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Hematemesis	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Intestinal Perforation	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
General disorders Peripheral Oedema	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Infections and infestations Bacteremia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Infections and infestations Device Related Infection	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Metabolism and nutrition disorders Malnutrition	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Infections and infestations Escherichia Bacteraemia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.

Other adverse events

Measure	Part 1A: FPA144 Dose Escalation Solid Tumors 0.3 mg/kg n=3 participants at risk 3 + 3 dose escalation cohort with 0.3 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 1.0 mg/kg n=4 participants at risk 3 + 3 dose escalation cohort with 1.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 3.0 mg/kg n=3 participants at risk 3 + 3 dose escalation cohort with 3.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 6.0 mg/kg n=3 participants at risk 3 + 3 dose escalation cohort with 6.0 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 10 mg/kg n=3 participants at risk 3 + 3 dose escalation cohort with 10 mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1A: FPA144 Dose Escalation Solid Tumors 15 mg/kg n=3 participants at risk 3 + 3 dose escalation cohort with 15mg/kg FPA144 IV every 2 weeks in 28 day cycles.	Part 1B: FPA144 Dose Escalation Gastric Cancer 3 mg/kg n=1 participants at risk 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 3.0 mg/kg IV every 2 weeks in 28 day cycles	Part 1B: FPA144 Dose Escalation Gastric Cancer 6 mg/kg n=1 participants at risk 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 6.0 mg/kg IV every 2 weeks in 28 day cycles	Part 1B: FPA144 Dose Escalation Gastric Cancer 10 mg/kg n=6 participants at risk 3 + 3 dose escalation cohort with expansion enrolling patients with gastric cancer. Tumors tested retrospectively for FGFR2 gene-amplified or FGFR2b protein-overexpressed. Expansion patients enrolled at dose levels cleared in Part 1A. Patients administered FPA144 10 mg/kg IV every 2 weeks in 28 day cycles	Part 2: FPA144 Dose Expansion Gastric or Other Solid Tumors n=52 participants at risk Gastric and bladder cancer patients with tumors with FGFR2b overexpression administered FPA144 15mg/kg IV every 2 weeks in 28 day cycles. Dose established from prior dose escalation evaluation in parts 1A and 1B.
General disorders Asthenia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 2/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
General disorders Chest Pain	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	3.8% 2/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
General disorders Chills	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
General disorders Early Satiety	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
General disorders Facial Pain	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
General disorders Fatigue	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	66.7% 2/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	100.0% 1/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 2/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	23.1% 12/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
General disorders Oedema Peripheral	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	50.0% 3/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	13.5% 7/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
General disorders Pyrexia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	13.5% 7/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Abdominal Distention	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	7.7% 4/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 2/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	5.8% 3/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Ascites	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	7.7% 4/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Constipation	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	13.5% 7/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	15.4% 8/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Dry Mouth	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 2/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	5.8% 3/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	5.8% 3/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Gastrointestinal Sounds Abnormal	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	66.7% 2/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	100.0% 1/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 2/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	13.5% 7/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	5.8% 3/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Melaena	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Nausea	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	100.0% 1/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	26.9% 14/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Oesophageal Hemorrhage	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Oesophagitis	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Blood and lymphatic system disorders Anemia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	26.9% 14/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Cardiac disorders Atrial Fibrillation	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Cardiac disorders Tachycardia	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Ear and labyrinth disorders Ear Pain	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Ear and labyrinth disorders Eustachian Tube Obstruction	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Eye disorders Dry Eye	66.7% 2/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	66.7% 2/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	13.5% 7/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Eye disorders Eye Disorder	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Eye disorders Eye Pruritus	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Eye disorders Keratitis	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Eye disorders Lacrimation Increased	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	5.8% 3/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Eye disorders Limbal Stem Cell Deficiency	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Eye disorders Metamorphosia	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Infections and infestations Anorectal Infection	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Infections and infestations Bronchitis	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Infections and infestations Ear Infection	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Infections and infestations Fungal Skin Infection	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Infections and infestations Oral Herpes	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Infections and infestations Pharyngitis	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Infections and infestations Pneumonia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	3.8% 2/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Infections and infestations Sinusitis	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Infections and infestations Skin Infection	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Infections and infestations Upper Respiratory Infection	66.7% 2/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Injury, poisoning and procedural complications Infusion Related Reaction	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 2/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Injury, poisoning and procedural complications Muscle Strain	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Injury, poisoning and procedural complications Wound Dehiscence	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Investigations Alanine Aminotransferase Increase	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	7.7% 4/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Investigations Aspartate Aminotransferase Increased	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 2/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	7.7% 4/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Investigations Blood Alkaline Phosphatase Increased	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	5.8% 3/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Investigations Blood Creatinine Increased	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	5.8% 3/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Investigations Lymphocyte Count Decreased	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Investigations Neutrophil Count Decreased	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 2/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Investigations Platelet Count Decreased	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Investigations Weight Decreased	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	9.6% 5/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Metabolism and nutrition disorders Decreased Appetite	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	50.0% 2/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	66.7% 2/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	100.0% 1/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	30.8% 16/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	66.7% 2/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	3.8% 2/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	5.8% 3/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 2/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	11.5% 6/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	5.8% 3/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	5.8% 3/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	100.0% 1/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	11.5% 6/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Musculoskeletal and connective tissue disorders Bone Pain	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	3.8% 2/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	7.7% 4/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer Pain	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	5.8% 3/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Pain	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Nervous system disorders Dizziness	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	100.0% 1/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Nervous system disorders Dysgeusia	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Nervous system disorders Headache	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Nervous system disorders Lethargy	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Nervous system disorders Nervous System Disorder	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Nervous system disorders Neuropathy Peripheral	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	100.0% 1/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	5.8% 3/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Nervous system disorders Paresthesia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Psychiatric disorders Anxiety	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Psychiatric disorders Depression	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Renal and urinary disorders Chromaturia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Renal and urinary disorders Cystitis Non-infective	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Renal and urinary disorders Urinary Retention	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	5.8% 3/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Reproductive system and breast disorders Dyspareunia	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Reproductive system and breast disorders Vulvovaginal Dryness	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	66.7% 2/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	50.0% 3/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	7.7% 4/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Respiratory, thoracic and mediastinal disorders Nasal Ulcer	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 2/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	3.8% 2/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Respiratory, thoracic and mediastinal disorders Rhinalgia	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	1.9% 1/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Respiratory, thoracic and mediastinal disorders Sinus Congestion	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Respiratory, thoracic and mediastinal disorders Upper Airway Cough Syndrome	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Skin and subcutaneous tissue disorders Actinic Keratosis	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Skin and subcutaneous tissue disorders Alopecia	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	100.0% 1/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Skin and subcutaneous tissue disorders Erythema	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Skin and subcutaneous tissue disorders Hair Colour Changes	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Skin and subcutaneous tissue disorders Nail Disorder	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	100.0% 1/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	3.8% 2/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Skin and subcutaneous tissue disorders Onychomadesis	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	100.0% 1/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	100.0% 1/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	16.7% 1/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	5.8% 3/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	100.0% 1/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	5.8% 3/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Surgical and medical procedures Sinus Operation	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Vascular disorders Hypertension	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	25.0% 1/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	3.8% 2/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Vascular disorders Hypotension	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.
Gastrointestinal disorders Abdominal Pain	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	50.0% 2/4 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	33.3% 1/3 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	0.00% 0/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	100.0% 1/1 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	50.0% 3/6 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.	26.9% 14/52 • Adverse event data was collected from Cycle 1 Day 1 through completion of End-of-Treatment visit or until 28 days after last dose of study drug was administered.

Additional Information

Medical Lead

Five Prime Therapeutics

Phone: 415-365-5600

Email: FPA144@fiveprime.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place