Trial Outcomes & Findings for E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC) (NCT NCT00832819)

NCT ID: NCT00832819

Last Updated: 2015-04-30

Results Overview

Tolerability was confirmed by the frequency of occurrence of Dose Limiting Toxicities (DLTs) observed by the end of Cycle 1 in 6 participants.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 28 participants
• Primary outcome timeframe: 7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from Cycle 1
• Results posted on: 2015-04-30

Participant Flow

Participant milestones

Measure	E7080 4 mg BID (Dose Escalation) E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.	E7080 6 mg BID (Dose Escalation) E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.	E7080 4 mg BID (Expansion) Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
Overall Study STARTED	6	6	16
Overall Study COMPLETED	6	5	15
Overall Study NOT COMPLETED	0	1	1

Reasons for withdrawal

Measure	E7080 4 mg BID (Dose Escalation) E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.	E7080 6 mg BID (Dose Escalation) E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.	E7080 4 mg BID (Expansion) Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
Overall Study Adverse Event	0	1	0
Overall Study Protocol Violation	0	0	1

Baseline Characteristics

E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Measure	E7080 4 mg BID (Dose Escalation) n=6 Participants E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (Area under the curve (AUC) 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.	E7080 6 mg BID (Dose Escalation) n=6 Participants E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.	E7080 4 mg BID (Expansion) n=16 Participants Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.	Total n=28 Participants Total of all reporting groups
Age, Continuous	52.8 Years STANDARD_DEVIATION 9.3 • n=93 Participants	54.8 Years STANDARD_DEVIATION 9.7 • n=4 Participants	58.4 Years STANDARD_DEVIATION 11.2 • n=27 Participants	56.4 Years STANDARD_DEVIATION 10.4 • n=483 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	7 Participants n=483 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	4 Participants n=4 Participants	13 Participants n=27 Participants	21 Participants n=483 Participants

PRIMARY outcome

Timeframe: 7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from Cycle 1

Population: DLTs were analyzed on the Safety Analysis Set; however subjects with 75% or less treatment compliance for E7080 in Cycle 1 or those who discontinued the study and had no confirmed data on tolerability up to Cycle 1 Day 22 were excluded from this analysis.

Tolerability was confirmed by the frequency of occurrence of Dose Limiting Toxicities (DLTs) observed by the end of Cycle 1 in 6 participants.

Outcome measures

Measure	E7080 6 mg BID (Dose Escalation) n=6 Participants E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
Maximum Tolerated Dose (MTD)	4 mg BID

SECONDARY outcome

Timeframe: At Screening, on Day 22 of every even cycle, and at discontinuation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At various time points until Day 22 of Cycle 1

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Throughout the study until 30 days after last dose

Refer safety section for safety analysis

Outcome measures

Outcome data not reported

Adverse Events

E7080 4 mg BID (Dose Escalation)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

E7080 6 mg BID (Dose Escalation)

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

E7080 4 mg BID (Expansion)

Serious events: 6 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	E7080 4 mg BID (Dose Escalation) n=6 participants at risk E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.	E7080 6 mg BID (Dose Escalation) n=6 participants at risk E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.	E7080 4 mg BID (Expansion) n=16 participants at risk Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
Nervous system disorders Syncope	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Injury, poisoning and procedural complications Wound	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Vascular disorders Haematoma	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Infections and infestations Pneumonia	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Metabolism and nutrition disorders Decreased Appetite	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Infections and infestations Pyelonephritis	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Vascular disorders Thrombosis	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	12.5% 2/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatses to meninges	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.

Other adverse events

Measure	E7080 4 mg BID (Dose Escalation) n=6 participants at risk E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.	E7080 6 mg BID (Dose Escalation) n=6 participants at risk E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.	E7080 4 mg BID (Expansion) n=16 participants at risk Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
Blood and lymphatic system disorders Anaemia	66.7% 4/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	66.7% 4/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	81.2% 13/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Blood and lymphatic system disorders Erythropenia	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	12.5% 2/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	18.8% 3/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Blood and lymphatic system disorders Leukopenia	100.0% 6/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	83.3% 5/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	93.8% 15/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Blood and lymphatic system disorders Lymphopenia	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	50.0% 3/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	62.5% 10/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Blood and lymphatic system disorders Neutropenia	100.0% 6/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	83.3% 5/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	93.8% 15/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Blood and lymphatic system disorders Neutrophilia	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Blood and lymphatic system disorders Thrombocytopenia	100.0% 6/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	66.7% 4/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	100.0% 16/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Cardiac disorders Atrioventricular block first degree	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Cardiac disorders Tachycardia	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Cardiac disorders Ventricular extrasystoles	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Ear and labyrinth disorders Ear pruritus	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Endocrine disorders Hyperthyroidism	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Endocrine disorders Hypothyroidism	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	66.7% 4/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	43.8% 7/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Endocrine disorders Thyroiditis subacute	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Eye disorders Cataract	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Eye disorders Conjunctival haemorrhage	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Eye disorders Conjunctivitis	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Eye disorders Dacryostenosis acquired	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Eye disorders Eyelid oedema	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Abdominal pain upper	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Anal erosion	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Cheilitis	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Constipation	83.3% 5/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	66.7% 4/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	75.0% 12/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Dental caries	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Diarrhoea	100.0% 6/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	66.7% 4/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	75.0% 12/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Enteritis	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Enterocolitis	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Gastritis	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	12.5% 2/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Gingival discolouration	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Gingivitis	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	25.0% 4/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Nausea	83.3% 5/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	100.0% 6/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	81.2% 13/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Oesophagitis	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Periodontal disease	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	12.5% 2/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Reflux oesophagitis	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Stomatitis	50.0% 3/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	43.8% 7/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Gastrointestinal disorders Vomiting	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	50.0% 3/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	50.0% 8/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
General disorders Chest pain	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
General disorders Extravasation	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	12.5% 2/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
General disorders Face oedema	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
General disorders Fatigue	83.3% 5/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	83.3% 5/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	62.5% 10/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
General disorders Impaired healing	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
General disorders Injection site reaction	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
General disorders Mucosal inflammation	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
General disorders Oedema peripheral	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
General disorders Pyrexia	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	12.5% 2/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Hepatobiliary disorders Hyperbilirubinaemia	50.0% 3/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	50.0% 3/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	43.8% 7/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Infections and infestations Anal abscess	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Infections and infestations Bronchitis	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Infections and infestations Cystitis	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Infections and infestations Gingival infection	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Infections and infestations Herpes zoster	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Infections and infestations Infection	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	12.5% 2/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Infections and infestations Nasopharyngitis	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	18.8% 3/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Infections and infestations Oral herpes	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Infections and infestations Pharyngitis	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	18.8% 3/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Infections and infestations Pneumonia	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Infections and infestations Subcutaneous abscess	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Infections and infestations Upper respiratory tract infection	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Injury, poisoning and procedural complications Contusion	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Investigations Alanine aminotransferase increased	66.7% 4/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	50.0% 3/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	50.0% 8/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Investigations Aspartate aminotransferase increased	66.7% 4/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	100.0% 6/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	31.2% 5/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Investigations Blood alkaline phosphatase increased	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	18.8% 3/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Investigations Blood creatinine increased	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	25.0% 4/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Investigations Blood lactate dehydrogenase increased	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	25.0% 4/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Investigations Blood thyroid stimulating hormone increased	50.0% 3/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	31.2% 5/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Investigations Blood urea increased	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	31.2% 5/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Investigations Blood urine present	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	50.0% 3/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	31.2% 5/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Investigations C-reactive protein increased	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	18.8% 3/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Investigations Electrocardiogram T wave abnormal	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Investigations Fibrin D dimer increased	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Investigations Gamma-glutamyltransferase increased	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	31.2% 5/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Investigations Haemoglobin decreased	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	12.5% 2/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Investigations Occult blood	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Investigations Protein total decreased	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	31.2% 5/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Investigations Weight decreased	50.0% 3/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	83.3% 5/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	50.0% 8/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Investigations Weight increased	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	12.5% 2/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Metabolism and nutrition disorders Decreased appetite	66.7% 4/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	66.7% 4/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	81.2% 13/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Metabolism and nutrition disorders Dehydration	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	18.8% 3/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Metabolism and nutrition disorders Hypercalcaemia	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Metabolism and nutrition disorders Hypercholesterolaemia	66.7% 4/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	50.0% 3/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	50.0% 8/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Metabolism and nutrition disorders Hyperkalaemia	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Metabolism and nutrition disorders Hypoalbuminaemia	66.7% 4/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	50.0% 3/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	62.5% 10/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Metabolism and nutrition disorders Hypocalcaemia	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	18.8% 3/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Metabolism and nutrition disorders Hypochloraemia	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	12.5% 2/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Metabolism and nutrition disorders Hyponatraemia	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	12.5% 2/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Metabolism and nutrition disorders Hypoproteinaemia	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Musculoskeletal and connective tissue disorders Arthralgia	83.3% 5/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	83.3% 5/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	100.0% 16/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Musculoskeletal and connective tissue disorders Haemarthrosis	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Musculoskeletal and connective tissue disorders Muscle spasms	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Musculoskeletal and connective tissue disorders Myalgia	66.7% 4/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	68.8% 11/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	12.5% 2/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Nervous system disorders Cranial nerve disorder	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Nervous system disorders Dizziness	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	25.0% 4/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Nervous system disorders Dysgeusia	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	50.0% 8/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Nervous system disorders Head discomfort	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Nervous system disorders Headache	50.0% 3/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	50.0% 8/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Nervous system disorders Peripheral motor neuropathy	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	12.5% 2/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Nervous system disorders Peripheral sensory neuropathy	100.0% 6/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	83.3% 5/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	93.8% 15/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Psychiatric disorders Depression	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	12.5% 2/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Psychiatric disorders Insomnia	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	25.0% 4/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Renal and urinary disorders Glycosuria	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Renal and urinary disorders Haematuria	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Renal and urinary disorders Neurogenic bladder	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Renal and urinary disorders Pollakiuria	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Renal and urinary disorders Proteinuria	100.0% 6/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	50.0% 3/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	68.8% 11/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Renal and urinary disorders Urethral haemorrhage	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Reproductive system and breast disorders Penile haemorrhage	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Respiratory, thoracic and mediastinal disorders Dysphonia	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	31.2% 5/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	12.5% 2/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Respiratory, thoracic and mediastinal disorders Epistaxis	50.0% 3/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	50.0% 3/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	75.0% 12/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Respiratory, thoracic and mediastinal disorders Haemoptysis	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	18.8% 3/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Respiratory, thoracic and mediastinal disorders Hiccups	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	37.5% 6/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Respiratory, thoracic and mediastinal disorders Nasal inflammation	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Respiratory, thoracic and mediastinal disorders Respiratory tract haemorrhage	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Skin and subcutaneous tissue disorders Acne	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	12.5% 2/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Skin and subcutaneous tissue disorders Alopecia	100.0% 6/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	83.3% 5/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	93.8% 15/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	18.8% 3/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Skin and subcutaneous tissue disorders Hyperkeratosis	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	18.8% 3/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Skin and subcutaneous tissue disorders Pruritus	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	18.8% 3/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Skin and subcutaneous tissue disorders Rash	66.7% 4/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	83.3% 5/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	75.0% 12/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Vascular disorders Angiopathy	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Vascular disorders Flushing	33.3% 2/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	16.7% 1/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	12.5% 2/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Vascular disorders Hypertension	83.3% 5/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	83.3% 5/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	68.8% 11/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Vascular disorders Hypotension	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.
Vascular disorders Phlebitis	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	0.00% 0/6 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.	6.2% 1/16 • Throughout the study until 30 days after last dose All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.

Additional Information

Wataru Yusa

Eisai Co., Ltd.

Phone: +81 3-3817-5252

Results disclosure agreements

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

Restriction type: OTHER