Trial Outcomes & Findings for Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery (NCT NCT01181141)

NCT ID: NCT01181141

Last Updated: 2019-03-05

Results Overview

Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 92 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2019-03-05

Participant Flow

Participant milestones

Measure	DU-176b DU-176b oral tablets, 30 mg., taken once daily for 2 weeks DU-176b (edoxaban)	Enoxaparin Sodium Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks Enoxaparin sodium 20mg
Overall Study STARTED	62	30
Overall Study Safety Analysis Population	59	29
Overall Study COMPLETED	50	26
Overall Study NOT COMPLETED	12	4

Reasons for withdrawal

Measure	DU-176b DU-176b oral tablets, 30 mg., taken once daily for 2 weeks DU-176b (edoxaban)	Enoxaparin Sodium Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks Enoxaparin sodium 20mg
Overall Study Adverse Event	2	1
Overall Study Lack of Efficacy	1	0
Overall Study Lost to Follow-up	1	1
Overall Study Physician Decision	2	0
Overall Study Protocol Violation	3	1
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery

Baseline characteristics by cohort

Measure	DU-176b n=59 Participants DU-176b oral tablets, 30 mg., taken once daily for 2 weeks DU-176b (edoxaban)	Enoxaparin Sodium n=29 Participants Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks Enoxaparin sodium 20mg	Total n=88 Participants Total of all reporting groups
Age, Continuous	76.5 years STANDARD_DEVIATION 11.0 • n=5 Participants	75.6 years STANDARD_DEVIATION 12.0 • n=7 Participants	76.3 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	22 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	59 Participants n=5 Participants	29 Participants n=7 Participants	88 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Japan	59 participants n=5 Participants	29 participants n=7 Participants	88 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: Safety Analysis Set defined as all subjects who were secondarily enrolled in study, but excluded those with significant GCP violations, did not receive any study drug, or had no safety data after start of study treatment. However, subjects who had significant GCP violations, but received at least one dose of study drug, safety data were assessed.

Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints.

Outcome measures

Measure	DU-176b n=59 Participants DU-176b oral tablets, 30 mg., taken once daily for 2 weeks DU-176b (edoxaban)	Enoxaparin Sodium n=29 Participants Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks Enoxaparin sodium 20mg
The Incidence of Major or Clinically Relevant Non-major Bleeding	3.4 percentage of subjects with bleeds Interval 0.9 to 11.4	6.9 percentage of subjects with bleeds Interval 1.9 to 22.0

SECONDARY outcome

Timeframe: 2 weeks

Outcome measures

Outcome data not reported

Adverse Events

DU-176b

Serious events: 3 serious events

Other events: 43 other events

Deaths: 0 deaths

Enoxaparin Sodium

Serious events: 3 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	DU-176b n=59 participants at risk DU-176b oral tablets, 30 mg., taken once daily for 2 weeks DU-176b (edoxaban)	Enoxaparin Sodium n=29 participants at risk Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks Enoxaparin sodium 20mg
Infections and infestations postoperative wound infection	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Injury, poisoning and procedural complications subdural haematoma	1.7% 1/59 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	0.00% 0/29 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Injury, poisoning and procedural complications thoracic vertebral fracture	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Injury, poisoning and procedural complications fracture displacement	3.4% 2/59 • Number of events 2 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.

Other adverse events

Measure	DU-176b n=59 participants at risk DU-176b oral tablets, 30 mg., taken once daily for 2 weeks DU-176b (edoxaban)	Enoxaparin Sodium n=29 participants at risk Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks Enoxaparin sodium 20mg
Infections and infestations cystitis	5.1% 3/59 • Number of events 3 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	6.9% 2/29 • Number of events 2 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Infections and infestations nasopharyngitis	5.1% 3/59 • Number of events 3 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	6.9% 2/29 • Number of events 2 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Infections and infestations urinary tract infection	11.9% 7/59 • Number of events 7 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	13.8% 4/29 • Number of events 5 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Gastrointestinal disorders constipation	5.1% 3/59 • Number of events 3 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	0.00% 0/29 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Gastrointestinal disorders diarrhea	5.1% 3/59 • Number of events 4 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	10.3% 3/29 • Number of events 4 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Skin and subcutaneous tissue disorders decubitis ulcer	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	10.3% 3/29 • Number of events 3 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Skin and subcutaneous tissue disorders haemorrhage subcutaneous	6.8% 4/59 • Number of events 4 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 3 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Skin and subcutaneous tissue disorders urticaria	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	6.9% 2/29 • Number of events 2 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Investigations Alanine aminotransferase increased	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	13.8% 4/29 • Number of events 4 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Investigations Aspartate aminotransferase increased	3.4% 2/59 • Number of events 2 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	17.2% 5/29 • Number of events 5 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Investigations Gamma-glutamyltransferase increased	3.4% 2/59 • Number of events 2 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	10.3% 3/29 • Number of events 3 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Investigations blood urine present	15.3% 9/59 • Number of events 9 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	13.8% 4/29 • Number of events 4 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Injury, poisoning and procedural complications contusion	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	6.9% 2/29 • Number of events 2 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Injury, poisoning and procedural complications Post procedural haematoma	1.7% 1/59 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	6.9% 2/29 • Number of events 2 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Infections and infestations Postoperative wound infection	1.7% 1/59 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Psychiatric disorders Insomnia	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	3.4% 2/59 • Number of events 2 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	0.00% 0/29 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Gastrointestinal disorders anal haemorrhage	3.4% 2/59 • Number of events 2 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	0.00% 0/29 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Skin and subcutaneous tissue disorders Dermatitis contact	1.7% 1/59 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Skin and subcutaneous tissue disorders eczema	3.4% 2/59 • Number of events 2 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	0.00% 0/29 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Investigations Blood bilirubin increased	1.7% 1/59 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Investigations Blood uric acid increased	3.4% 2/59 • Number of events 2 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	0.00% 0/29 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Investigations Platelet count increased	1.7% 1/59 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 2 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Investigations Eosinophil percentage increased	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Investigations Spinal compression fracture	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Injury, poisoning and procedural complications Fracture displacement	3.4% 2/59 • Number of events 2 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 2 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Ear and labyrinth disorders vertigo	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Cardiac disorders cardiac failure congestive	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Vascular disorders Haematoma	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Vascular disorders Orthostatic hypotension	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Vascular disorders Wound haemorrhage	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Musculoskeletal and connective tissue disorders tendon pain	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Renal and urinary disorders Pollakiuria	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Cardiac disorders Chest discomfort	3.4% 2/59 • Number of events 2 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	0.00% 0/29 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
General disorders pyrexia	1.7% 1/59 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
Gastrointestinal disorders dyspepsia	0.00% 0/59 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.	3.4% 1/29 • Number of events 1 Safety Analysis Set defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.

Additional Information

Kenichi Sakakura, Manager

Daiichi Sankyo.,LTD

Phone: 81-90-1885-0271

Email: sakakura.kenichi.ef@daiichisankyo.co.jp

Results disclosure agreements

• Principal investigator is a sponsor employee PI shall not publish the results of the Study at any time without the prior written approval of Sponsor.
• Publication restrictions are in place

Restriction type: OTHER