Trial Outcomes & Findings for Phase 1 Study of E7090 in Subjects With Solid Tumor (NCT NCT02275910)

Last Updated: 2025-12-16

Results Overview

DLT was graded using Common Terminology Criteria for Adverse Events version 4.03 as follows: a. febrile neutropenia, or Grade 4 neutropenia persisting for greater than or equal to (\>=) 7 days, b. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia requiring platelet transfusions, c. Grade \>=3 non-hematological toxicity, except for: clinically insignificant laboratory abnormalities, toxicity Grade less than or equal to (\<=) 2 by best supportive care; d. potentially clinically significant, new radiographic mineralization in soft tissue, kidneys, intestines, heart, lungs, or other organs; e. Hyperphosphatemia meeting either for: serum phosphate level greater than (\>) 7 milligram per deciliter (mg/dL) persisting for \>=7 days despite best treatment, serum phosphate level \>9 mg/dL despite best treatment; f. treatment interruption for \>=8 days during Cycle 0; Cycle 1 required by E7090-related toxicity, except for treatment interruption for \>=8 days for reasons other than toxicity.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

40 participants

Primary outcome timeframe

Cycle 0 (Cycle length= 7 days) up to Cycle 1 (Cycle length= 28 days)

Results posted on

2025-12-16

Participant Flow

Participants took part in the study at 18 investigative sites in Japan from 28 October 2014 to 03 September 2021.

A total of 40 participants were enrolled in this study. This study consisted of two parts: Part 1 and Part 2. In Part 1, 24 participants were enrolled and received study treatment and in Part 2, 16 participants were enrolled and received the study treatment.

Participant milestones

Participant milestones
Measure	Part 1: E7090 1 mg With Solid Tumor Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 2 mg With Solid Tumor Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 4 mg With Solid Tumor Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 8 mg With Solid Tumor Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 16 mg With Solid Tumor Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 30 mg With Solid Tumor Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 60 mg With Solid Tumor Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 100 mg With Solid Tumor Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 140 mg With Solid Tumor Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 180 mg With Solid Tumor Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Gastric Cancer Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Cholangiocarcinoma Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.
Overall Study STARTED	2	2	2	2	2	2	3	3	3	3	10	6
Overall Study COMPLETED	2	2	2	2	2	2	2	2	2	2	10	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	1	1	1	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: E7090 1 mg With Solid Tumor Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 2 mg With Solid Tumor Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 4 mg With Solid Tumor Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 8 mg With Solid Tumor Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 16 mg With Solid Tumor Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 30 mg With Solid Tumor Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 60 mg With Solid Tumor Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 100 mg With Solid Tumor Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 140 mg With Solid Tumor Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 180 mg With Solid Tumor Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Gastric Cancer Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Cholangiocarcinoma Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.
Overall Study Subject Choice	0	0	0	0	0	0	0	0	1	0	0	0
Overall Study Radiological Disease Progression	0	0	0	0	0	0	1	1	0	1	0	0

Baseline Characteristics

Phase 1 Study of E7090 in Subjects With Solid Tumor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: E7090 1 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 2 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 4 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 8 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 16 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 30 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 60 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 100 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 140 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 180 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Gastric Cancer n=10 Participants Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Cholangiocarcinoma n=6 Participants Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Total n=40 Participants Total of all reporting groups
Race/Ethnicity, Customized Japanese	2 Participants n=6 Participants	2 Participants n=5 Participants	2 Participants n=5 Participants	2 Participants n=387 Participants	2 Participants n=18 Participants	1 Participants n=182 Participants	3 Participants n=3 Participants	3 Participants n=10 Participants	3 Participants n=27 Participants	3 Participants n=54 Participants	10 Participants n=705 Participants	6 Participants n=41 Participants	39 Participants n=187 Participants
Age, Continuous	67.5 years STANDARD_DEVIATION 6.36 • n=6 Participants	68.0 years STANDARD_DEVIATION 5.66 • n=5 Participants	57.5 years STANDARD_DEVIATION 3.54 • n=5 Participants	58.5 years STANDARD_DEVIATION 23.33 • n=387 Participants	58.5 years STANDARD_DEVIATION 6.36 • n=18 Participants	58.5 years STANDARD_DEVIATION 6.36 • n=182 Participants	71.0 years STANDARD_DEVIATION 3.61 • n=3 Participants	67.0 years STANDARD_DEVIATION 1.00 • n=10 Participants	64.0 years STANDARD_DEVIATION 6.93 • n=27 Participants	53.3 years STANDARD_DEVIATION 11.93 • n=54 Participants	67.5 years STANDARD_DEVIATION 9.07 • n=705 Participants	53.7 years STANDARD_DEVIATION 10.65 • n=41 Participants	62.5 years STANDARD_DEVIATION 10.05 • n=187 Participants
Sex: Female, Male Female	2 Participants n=6 Participants	1 Participants n=5 Participants	1 Participants n=5 Participants	1 Participants n=387 Participants	1 Participants n=18 Participants	0 Participants n=182 Participants	2 Participants n=3 Participants	1 Participants n=10 Participants	1 Participants n=27 Participants	3 Participants n=54 Participants	3 Participants n=705 Participants	1 Participants n=41 Participants	17 Participants n=187 Participants
Sex: Female, Male Male	0 Participants n=6 Participants	1 Participants n=5 Participants	1 Participants n=5 Participants	1 Participants n=387 Participants	1 Participants n=18 Participants	2 Participants n=182 Participants	1 Participants n=3 Participants	2 Participants n=10 Participants	2 Participants n=27 Participants	0 Participants n=54 Participants	7 Participants n=705 Participants	5 Participants n=41 Participants	23 Participants n=187 Participants
Race/Ethnicity, Customized Chinese	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=387 Participants	0 Participants n=18 Participants	1 Participants n=182 Participants	0 Participants n=3 Participants	0 Participants n=10 Participants	0 Participants n=27 Participants	0 Participants n=54 Participants	0 Participants n=705 Participants	0 Participants n=41 Participants	1 Participants n=187 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	2 Participants n=6 Participants	2 Participants n=5 Participants	2 Participants n=5 Participants	2 Participants n=387 Participants	2 Participants n=18 Participants	2 Participants n=182 Participants	3 Participants n=3 Participants	3 Participants n=10 Participants	3 Participants n=27 Participants	3 Participants n=54 Participants	10 Participants n=705 Participants	6 Participants n=41 Participants	40 Participants n=187 Participants

PRIMARY outcome

Timeframe: Cycle 0 (Cycle length= 7 days) up to Cycle 1 (Cycle length= 28 days)

Population: The DLT analysis set was the group of participants in the Part 1 who completed Cycle 0 and Cycle 1 treatment of E7090 with at least 75% compliance and were evaluated for DLT, and those who developed DLT during Cycle 0 or Cycle 1. This outcome measure was planned to be analyzed for Part 1 only.

Outcome measures

Outcome measures
Measure	Part 1: E7090 180 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 1 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 2 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 4 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 8 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 16 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 30 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 60 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 100 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 140 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Gastric Cancer Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Cholangiocarcinoma Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: From the start of study drug administration up to 2 year 9 months

Population: The safety analysis set was the group of participants who received at least 1 dose of E7090. This outcome measure was planned to be analyzed for Part 1 and Part 2.

A TEAE was defined as an adverse event (AE) that emerged during the time from the first dose of study drug to 30 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. A Serious AE is any untoward medical occurrence that at any dose: resulted in death; was life threatening (that is, the participant was at immediate risk of death from the AE as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death) required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.

Outcome measures

Outcome measures
Measure	Part 1: E7090 180 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 1 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 2 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 4 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 8 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 16 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 30 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 60 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 100 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 140 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Gastric Cancer n=10 Participants Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Cholangiocarcinoma n=6 Participants Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	3 Participants	2 Participants	1 Participants	1 Participants	2 Participants	2 Participants	2 Participants	3 Participants	3 Participants	3 Participants	10 Participants	6 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	4 Participants	1 Participants

SECONDARY outcome

Timeframe: From the date of first dose of study drug up to 2 years and 8 months

Population: The efficacy analysis set was the group of participants who received at least 1 dose of E7090 and had both baseline and at least 1 post-baseline tumor assessments. This outcome measure was planned to be analyzed for Part 2 only.

OS was defined as the time from the date of first dose to the date of death from any cause. OS was estimated by using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Part 1: E7090 180 mg With Solid Tumor Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 1 mg With Solid Tumor n=9 Participants Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 2 mg With Solid Tumor n=6 Participants Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 4 mg With Solid Tumor Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 8 mg With Solid Tumor Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 16 mg With Solid Tumor Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 30 mg With Solid Tumor Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 60 mg With Solid Tumor Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 100 mg With Solid Tumor Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 140 mg With Solid Tumor Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Gastric Cancer Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Cholangiocarcinoma Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.
Part 2: Overall Survival (OS)	—	4.27 months Interval 2.23 to 7.95	22.49 months Interval 6.37 to Upper limit of confidence interval could not be estimated due to an insufficient number of events.	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the date of first dose of study drug up to 2 years and 8 months

PFS was defined as the time from the date of first dose to the first documented date of event (disease progression or death from any cause, whichever occurs first). PD was defined as at least a 20 percent (%) increase in the sum of LD of target and non-target lesions as compared with the smallest sum of long diameter (LD) and the increase of LD was at least 5 millimeter (mm) (including new lesions). The tumor assessment is based on Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria and was estimated using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Part 1: E7090 180 mg With Solid Tumor Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 1 mg With Solid Tumor n=9 Participants Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 2 mg With Solid Tumor n=6 Participants Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 4 mg With Solid Tumor Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 8 mg With Solid Tumor Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 16 mg With Solid Tumor Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 30 mg With Solid Tumor Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 60 mg With Solid Tumor Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 100 mg With Solid Tumor Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 140 mg With Solid Tumor Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Gastric Cancer Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Cholangiocarcinoma Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.
Part 2: Progression- Free Survival (PFS)	—	3.25 months Interval 0.95 to 4.86	8.26 months Interval 3.84 to Upper limit of confidence interval could not be estimated due to an insufficient number of events.	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the date of first dose of study drug up to 2 years and 8 months

Tumor assessment (target lesion, non-target lesion, and presence or absence of new lesion) was performed based on RECIST v1.1. Tumor marker was also measured. FDG-PET CT (fluorodeoxyglucose- Positron emission tomography computed tomography) also evaluated. Best overall responses were complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), and not evaluable (NE). CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is \<10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with baseline summed LD. SD was defined as no known evidence of progressive disease or new bone lesions where SD was achieved at \>=7 weeks after first dose.

Outcome measures

Outcome measures
Measure	Part 1: E7090 180 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 1 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 2 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 4 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 8 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 16 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 30 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 60 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 100 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 140 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Gastric Cancer n=9 Participants Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Cholangiocarcinoma n=6 Participants Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.
Best Overall Response (BOR) Complete Response (CR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Best Overall Response (BOR) Partial Response (PR)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	5 Participants
Best Overall Response (BOR) Stable Disease (SD)	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	4 Participants	1 Participants
Best Overall Response (BOR) Progressive Disease (PD)	1 Participants	1 Participants	2 Participants	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants	2 Participants	1 Participants	4 Participants	0 Participants
Best Overall Response (BOR) Not Evaluable (NE)	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From screening up to 2 years and 8 months

ORR was defined as a percentage of participants with BOR of CR or PR. ORR was assessed using RECIST 1.1. CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is \<10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with baseline summed LD.

Outcome measures

Outcome measures
Measure	Part 1: E7090 180 mg With Solid Tumor Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 1 mg With Solid Tumor n=9 Participants Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 2 mg With Solid Tumor n=6 Participants Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 4 mg With Solid Tumor Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 8 mg With Solid Tumor Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 16 mg With Solid Tumor Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 30 mg With Solid Tumor Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 60 mg With Solid Tumor Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 100 mg With Solid Tumor Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 140 mg With Solid Tumor Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Gastric Cancer Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Cholangiocarcinoma Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.
Part 2: Objective Response Rate (ORR)	—	11.1 percentage of participants Interval 0.3 to 48.2	83.3 percentage of participants Interval 35.9 to 99.6	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the date of first dose of study drug up to 2 years and 8 months

DCR was defined as the percentage of participants with BOR of CR, PR or SD. DCR was assessed based on RECIST 1.1. CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is \<10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with Baseline summed LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. SD was defined as no known evidence of progressive disease or new bone lesions where SD was achieved at \>= 7 weeks after first dose.

Outcome measures

Outcome measures
Measure	Part 1: E7090 180 mg With Solid Tumor Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 1 mg With Solid Tumor n=9 Participants Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 2 mg With Solid Tumor n=6 Participants Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 4 mg With Solid Tumor Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 8 mg With Solid Tumor Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 16 mg With Solid Tumor Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 30 mg With Solid Tumor Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 60 mg With Solid Tumor Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 100 mg With Solid Tumor Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 140 mg With Solid Tumor Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Gastric Cancer Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Cholangiocarcinoma Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.
Part 2: Disease Control Rate (DCR)	—	55.6 percentage of participants Interval 21.2 to 86.3	100.0 percentage of participants Interval 54.1 to 100.0	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose; (Cycle 1 is 28 days)

Population: The pharmacokinetic (PK) analysis set was the group of participants who received at least 1 dose of E7090 and had sufficient PK data to derive at least 1 PK parameter. This outcome measure was planned to be analyzed for Part 1 and Part 2.

Outcome measures

Outcome measures
Measure	Part 1: E7090 180 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 1 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 2 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 4 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 8 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 16 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 30 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 60 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 100 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 140 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Gastric Cancer n=10 Participants Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Cholangiocarcinoma n=6 Participants Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.
Cmax: Maximum Observed Plasma Concentration for E7090	140 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 34.6	NA nanogram per milliliter (ng/mL) Geometric Coefficient of Variation NA The plasma concentrations of E7090 were below the limit of quantification at 1 mg dose in participants with solid tumors; therefore, Cmax could not be calculated.	NA nanogram per milliliter (ng/mL) Geometric Coefficient of Variation NA The plasma concentrations of E7090 were below the limit of quantification at 2 mg dose in participants with solid tumors; therefore, Cmax could not be calculated.	1.27 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 112	2.89 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 4.41	8.54 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 86.7	23.9 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 98.1	38.5 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 11.9	82.5 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 34.9	206 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 58.7	188 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 53.2	59.4 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 107

SECONDARY outcome

Timeframe: Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose; (Cycle 1 is 28 days)

Population: The PK analysis set was the group of participants who received at least 1 dose of E7090 and had sufficient PK data to derive at least 1 PK parameter. This outcome measure was planned to be analyzed for Part 1 and Part 2.

Outcome measures

Outcome measures
Measure	Part 1: E7090 180 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 1 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 2 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 4 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 8 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 16 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 30 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 60 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 100 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 140 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Gastric Cancer n=10 Participants Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Cholangiocarcinoma n=6 Participants Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090	3.48 hour Interval 1.95 to 5.0	NA hour The plasma concentrations of E7090 were below the limit of quantification at 1 mg dose in participants with solid tumors; therefore, Tmax could not be calculated.	NA hour The plasma concentrations of E7090 were below the limit of quantification at 2 mg dose in participants with solid tumors; therefore, Tmax could not be calculated.	1.51 hour Interval 1.0 to 2.02	2.96 hour Interval 2.92 to 3.0	2.01 hour Interval 1.02 to 3.0	3.04 hour Interval 0.93 to 5.15	3.00 hour Interval 2.97 to 4.98	4.95 hour Interval 2.97 to 5.1	4.88 hour Interval 3.0 to 5.08	2.96 hour Interval 1.9 to 5.07	3.97 hour Interval 2.95 to 4.98

SECONDARY outcome

Timeframe: Part 1: Cycle 0 Day 1: 0-24 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose (Cycle 1 is 28 days)

Population: The PK analysis set was the group of participants who received at least 1 dose of E7090 and had sufficient PK data to derive at least 1 PK parameter. Here "overall number of participants analyzed" are those who were evaluable for this outcome measure. This outcome measure was planned to be analyzed for Part 1 and Part 2.

Outcome measures

Outcome measures
Measure	Part 1: E7090 180 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 1 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 2 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 4 mg With Solid Tumor n=1 Participants Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 8 mg With Solid Tumor n=1 Participants Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 16 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 30 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 60 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 100 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 140 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Gastric Cancer n=10 Participants Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Cholangiocarcinoma n=6 Participants Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.
AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours	1760 h*ng/mL Geometric Coefficient of Variation 50.4	NA h*ng/mL Geometric Coefficient of Variation NA The plasma concentrations of E7090 were below the limit of quantification at 1 mg dose in participants with solid tumors; therefore, AUC(0-24h) could not be calculated.	NA h*ng/mL Geometric Coefficient of Variation NA The plasma concentrations of E7090 were below the limit of quantification at 2 mg dose in participants with solid tumors; therefore, AUC(0-24h) could not be calculated.	5.71 h*ng/mL Geometric Coefficient of Variation NA As only one participant was present, Standard Deviation could not be calculated.	19.8 h*ng/mL Geometric Coefficient of Variation NA As only one participant was present, Standard Deviation could not be calculated.	55.1 h*ng/mL Geometric Coefficient of Variation 45.2	164 h*ng/mL Geometric Coefficient of Variation 39.4	341 h*ng/mL Geometric Coefficient of Variation 31.2	788 h*ng/mL Geometric Coefficient of Variation 52.2	2100 h*ng/mL Geometric Coefficient of Variation 80.5	1590 h*ng/mL Geometric Coefficient of Variation 70.5	618 h*ng/mL Geometric Coefficient of Variation 87.7

SECONDARY outcome

Timeframe: Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days)

Outcome measures

Outcome measures
Measure	Part 1: E7090 180 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 1 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 2 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 4 mg With Solid Tumor n=1 Participants Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 8 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 16 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 30 mg With Solid Tumor n=2 Participants Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 60 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 100 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 140 mg With Solid Tumor n=3 Participants Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Gastric Cancer Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Cholangiocarcinoma Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.
Part 1: CL/F: Apparent Total Clearance for E7090	66.7 Liter per hour (L/h) Geometric Coefficient of Variation 41.8	NA Liter per hour (L/h) Geometric Coefficient of Variation NA The plasma concentrations of E7090 were below the limit of quantification at 1 mg dose in participants with solid tumors; therefore, CL/F could not be calculated.	NA Liter per hour (L/h) Geometric Coefficient of Variation NA The plasma concentrations of E7090 were below the limit of quantification at 2 mg dose in participants with solid tumors; therefore, CL/F could not be calculated.	700 Liter per hour (L/h) Geometric Coefficient of Variation NA As only one participant was present, Standard Deviation could not be calculated.	NA Liter per hour (L/h) Geometric Coefficient of Variation NA CL/F could not be calculated as at least 3 concentration points in the terminal phase were not available due to being below the limit of quantification.	243 Liter per hour (L/h) Geometric Coefficient of Variation 60.2	126 Liter per hour (L/h) Geometric Coefficient of Variation 14.6	116 Liter per hour (L/h) Geometric Coefficient of Variation 41.2	95.5 Liter per hour (L/h) Geometric Coefficient of Variation 48.8	46.7 Liter per hour (L/h) Geometric Coefficient of Variation 109	—	—

Adverse Events

Part 1: E7090 1 mg With Solid Tumor

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: E7090 2 mg With Solid Tumor

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: E7090 4 mg With Solid Tumor

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: E7090 8 mg With Solid Tumor

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: E7090 16 mg With Solid Tumor

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: E7090 30 mg With Solid Tumor

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: E7090 60 mg With Solid Tumor

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: E7090 100 mg With Solid Tumor

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: E7090 140 mg With Solid Tumor

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1: E7090 180 mg With Solid Tumor

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 2: E7090 140 mg With Gastric Cancer

Serious events: 4 serious events

Other events: 10 other events

Deaths: 10 deaths

Part 2: E7090 140 mg With Cholangiocarcinoma

Serious events: 1 serious events

Other events: 6 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: E7090 1 mg With Solid Tumor n=2 participants at risk Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 2 mg With Solid Tumor n=2 participants at risk Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 4 mg With Solid Tumor n=2 participants at risk Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 8 mg With Solid Tumor n=2 participants at risk Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 16 mg With Solid Tumor n=2 participants at risk Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 30 mg With Solid Tumor n=2 participants at risk Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 60 mg With Solid Tumor n=3 participants at risk Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 100 mg With Solid Tumor n=3 participants at risk Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 140 mg With Solid Tumor n=3 participants at risk Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 180 mg With Solid Tumor n=3 participants at risk Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Gastric Cancer n=10 participants at risk Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Cholangiocarcinoma n=6 participants at risk Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.
Infections and infestations Pneumonia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Infections and infestations Septic shock	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Metabolism and nutrition disorders Decreased appetite	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Nervous system disorders Depressed level of consciousness	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Vascular disorders Thrombophlebitis migrans	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
General disorders Pyrexia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Gastrointestinal disorders Ileus	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Hepatobiliary disorders Cholangitis	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Hepatobiliary disorders Cholecystitis acute	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour obstruction	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months

Other adverse events

Other adverse events
Measure	Part 1: E7090 1 mg With Solid Tumor n=2 participants at risk Participants with solid tumor received E7090 1 milligram (mg) capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 2 mg With Solid Tumor n=2 participants at risk Participants with solid tumor received E7090 2 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 4 mg With Solid Tumor n=2 participants at risk Participants with solid tumor received E7090 4 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 8 mg With Solid Tumor n=2 participants at risk Participants with solid tumor received E7090 8 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 16 mg With Solid Tumor n=2 participants at risk Participants with solid tumor received E7090 16 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in 28-days treatment cycles for Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 30 mg With Solid Tumor n=2 participants at risk Participants with solid tumor received E7090 30 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 60 mg With Solid Tumor n=3 participants at risk Participants with solid tumor received E7090 60 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 100 mg With Solid Tumor n=3 participants at risk Participants with solid tumor received E7090 100 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 140 mg With Solid Tumor n=3 participants at risk Participants with solid tumor received E7090 140 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 1: E7090 180 mg With Solid Tumor n=3 participants at risk Participants with solid tumor received E7090 180 mg capsules orally, once on Day 1 of Cycle 0 (Cycle length=7 days) in the fasting state and thereafter once daily in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Gastric Cancer n=10 participants at risk Participants with gastric cancer received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.	Part 2: E7090 140 mg With Cholangiocarcinoma n=6 participants at risk Participants with Cholangiocarcinoma received E7090 140 mg capsules orally, on Days 1 and 8 of Cycle 1 in the fasting state and subsequent cycles (Cycle length=28 days) unless withdrawal of consent, major inclusion/exclusion criteria violation, difficulty in continuing the study due to an adverse event, pregnancy, disease progression, dose reduction to \<1 mg (Part 1) or \<35 mg (Part 2) required due to an adverse drug reaction, other cases where the investigator or subinvestigator considers study discontinuation appropriate.
Gastrointestinal disorders Nausea	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	100.0% 2/2 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	66.7% 2/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	66.7% 2/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	66.7% 2/3 • From the start of study drug administration up to 2 year and 9 months	100.0% 3/3 • From the start of study drug administration up to 2 year and 9 months	20.0% 2/10 • From the start of study drug administration up to 2 year and 9 months	66.7% 4/6 • From the start of study drug administration up to 2 year and 9 months
Gastrointestinal disorders Constipation	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	20.0% 2/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Gastrointestinal disorders Angular cheilitis	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Gastrointestinal disorders Dysphagia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Gastrointestinal disorders Vomiting	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	20.0% 2/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Gastrointestinal disorders Abdominal distension	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	30.0% 3/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Gastrointestinal disorders Stomatitis	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	30.0% 3/10 • From the start of study drug administration up to 2 year and 9 months	50.0% 3/6 • From the start of study drug administration up to 2 year and 9 months
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Gastrointestinal disorders Dry mouth	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	20.0% 2/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Gastrointestinal disorders Glossitis	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Gastrointestinal disorders Periodontal disease	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
General disorders Fatigue	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
General disorders Pyrexia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	66.7% 2/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	33.3% 2/6 • From the start of study drug administration up to 2 year and 9 months
General disorders Malaise	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
General disorders Mucosal inflammation	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
General disorders Oedema peripheral	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Infections and infestations Nasopharyngitis	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Infections and infestations Skin infection	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Infections and infestations Upper respiratory tract infection	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Infections and infestations Vaginal infection	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Infections and infestations Wound infection	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Infections and infestations Pharyngitis	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Infections and infestations Pyelonephritis	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Injury, poisoning and procedural complications Contusion	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Injury, poisoning and procedural complications Nail injury	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Injury, poisoning and procedural complications Wound complication	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Investigations Blood creatinine increased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	66.7% 2/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	100.0% 3/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	30.0% 3/10 • From the start of study drug administration up to 2 year and 9 months	33.3% 2/6 • From the start of study drug administration up to 2 year and 9 months
Investigations Alanine aminotransferase increased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	100.0% 3/3 • From the start of study drug administration up to 2 year and 9 months	66.7% 2/3 • From the start of study drug administration up to 2 year and 9 months	30.0% 3/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Investigations Lipase increased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	33.3% 2/6 • From the start of study drug administration up to 2 year and 9 months
Investigations Aspartate aminotransferase increased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	66.7% 2/3 • From the start of study drug administration up to 2 year and 9 months	66.7% 2/3 • From the start of study drug administration up to 2 year and 9 months	30.0% 3/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Investigations Blood alkaline phosphatase increased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	66.7% 2/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	30.0% 3/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Investigations Lymphocyte count decreased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Investigations Neutrophil count decreased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	66.7% 2/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
General disorders General physical health deterioration	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
General disorders Mucosal haemorrhage	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Investigations Blood urea increased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Investigations C-reactive protein increased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Investigations White blood cell count decreased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Investigations Gamma-glutamyltransferase increased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Investigations Platelet count decreased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Investigations Weight decreased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Investigations Bilirubin conjugated increased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Investigations Blood bilirubin increased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Investigations Blood lactate dehydrogenase increased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Investigations Fibrin D dimer increased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Investigations Weight increased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	100.0% 3/3 • From the start of study drug administration up to 2 year and 9 months	100.0% 3/3 • From the start of study drug administration up to 2 year and 9 months	100.0% 3/3 • From the start of study drug administration up to 2 year and 9 months	100.0% 10/10 • From the start of study drug administration up to 2 year and 9 months	100.0% 6/6 • From the start of study drug administration up to 2 year and 9 months
Metabolism and nutrition disorders Decreased appetite	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	40.0% 4/10 • From the start of study drug administration up to 2 year and 9 months	33.3% 2/6 • From the start of study drug administration up to 2 year and 9 months
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	30.0% 3/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	33.3% 2/6 • From the start of study drug administration up to 2 year and 9 months
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Nervous system disorders Paralysis recurrent laryngeal nerve	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Nervous system disorders Dizziness	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Psychiatric disorders Insomnia	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Psychiatric disorders Agitation	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Renal and urinary disorders Haematuria	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Renal and urinary disorders Hypertonic bladder	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Renal and urinary disorders Proteinuria	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Renal and urinary disorders Dysuria	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Renal and urinary disorders Hydronephrosis	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Reproductive system and breast disorders Genital haemorrhage	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Reproductive system and breast disorders Gynaecomastia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Skin and subcutaneous tissue disorders Onychomadesis	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Infections and infestations Paronychia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	50.0% 5/10 • From the start of study drug administration up to 2 year and 9 months	66.7% 4/6 • From the start of study drug administration up to 2 year and 9 months
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Respiratory, thoracic and mediastinal disorders Laryngeal pain	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Psychiatric disorders Delirium	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Eye disorders Eyelid ptosis	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Eye disorders Keratitis	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Eye disorders Periorbital oedema	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Eye disorders Subretinal fluid	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Eye disorders Retinal detachment	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Eye disorders Retinopathy	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Cardiac disorders Tachycardia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Eye disorders Serous retinal detachment	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	66.7% 2/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Eye disorders Dry eye	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	33.3% 2/6 • From the start of study drug administration up to 2 year and 9 months
Eye disorders Macular oedema	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Eye disorders Cataract	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Eye disorders Conjunctivitis allergic	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Eye disorders Corneal disorder	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	40.0% 4/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Blood and lymphatic system disorders Leukopenia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	20.0% 2/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	20.0% 2/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months
Nervous system disorders Dysgeusia	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	66.7% 2/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	40.0% 4/10 • From the start of study drug administration up to 2 year and 9 months	33.3% 2/6 • From the start of study drug administration up to 2 year and 9 months
Nervous system disorders Headache	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	33.3% 2/6 • From the start of study drug administration up to 2 year and 9 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Vascular disorders Hypotension	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/6 • From the start of study drug administration up to 2 year and 9 months
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	66.7% 2/3 • From the start of study drug administration up to 2 year and 9 months	40.0% 4/10 • From the start of study drug administration up to 2 year and 9 months	100.0% 6/6 • From the start of study drug administration up to 2 year and 9 months
Skin and subcutaneous tissue disorders Dry skin	50.0% 1/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/10 • From the start of study drug administration up to 2 year and 9 months	50.0% 3/6 • From the start of study drug administration up to 2 year and 9 months
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/2 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	0.00% 0/3 • From the start of study drug administration up to 2 year and 9 months	33.3% 1/3 • From the start of study drug administration up to 2 year and 9 months	10.0% 1/10 • From the start of study drug administration up to 2 year and 9 months	16.7% 1/6 • From the start of study drug administration up to 2 year and 9 months

Additional Information

Eisai Inquiry Service.

Eisai Co., Ltd.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place