Trial Outcomes & Findings for A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty (NCT NCT01203098)
NCT ID: NCT01203098
Last Updated: 2019-02-25
Results Overview
The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment. * Lower extremity DVT confirmed by bilateral venography at the end of study treatment * Definite diagnosis of symptomatic PE * Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
264 participants
Primary outcome timeframe
2 weeks
Results posted on
2019-02-25
Participant Flow
Participant milestones
| Measure |
DU-176b 15 mg
DU-176b 15 mg tablets, oral once daily for 2 weeks
|
DU-176b 30 mg
DU-176b 30 mg tablets oral, once daily for 2 weeks
|
Enoxaparin Sodium 20mg (2000IU)
Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
89
|
86
|
89
|
|
Overall Study
Safety Analysis Dataset
|
89
|
85
|
87
|
|
Overall Study
COMPLETED
|
83
|
82
|
78
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
11
|
Reasons for withdrawal
| Measure |
DU-176b 15 mg
DU-176b 15 mg tablets, oral once daily for 2 weeks
|
DU-176b 30 mg
DU-176b 30 mg tablets oral, once daily for 2 weeks
|
Enoxaparin Sodium 20mg (2000IU)
Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
2
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
3
|
Baseline Characteristics
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
Baseline characteristics by cohort
| Measure |
DU-176b 15 mg
n=78 Participants
DU-176b 15 mg tablets, oral once daily for 2 weeks
|
DU-176b 30 mg
n=72 Participants
DU-176b 30 mg tablets oral, once daily for 2 weeks
|
Enoxaparin Sodium 20mg (2000IU)
n=74 Participants
Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
58.9 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
191 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
78 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
75 participants
n=5 Participants
|
70 participants
n=7 Participants
|
70 participants
n=5 Participants
|
215 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: The FAS was defined as all subjects enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or those who did not develop symptomatic DVT or PE, but in whom venography was not appropriately performed.
The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment. * Lower extremity DVT confirmed by bilateral venography at the end of study treatment * Definite diagnosis of symptomatic PE * Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE
Outcome measures
| Measure |
DU-176b 15 mg
n=78 Participants
DU-176b 15 mg tablets, oral once daily for 2 weeks
|
DU-176b 30 mg
n=72 Participants
DU-176b 30 mg tablets oral, once daily for 2 weeks
|
Enoxaparin Sodium 20mg (2000IU)
n=74 Participants
Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
|
|---|---|---|---|
|
Percentage of Subjects With Venous Thromboembolism Events
|
3.8 percent of participants with VTE event
Interval 0.0 to 8.1
|
2.8 percent of participants with VTE event
Interval 0.0 to 6.6
|
4.1 percent of participants with VTE event
Interval 0.0 to 8.5
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: The Safety Analysis Set was 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
Outcome measures
| Measure |
DU-176b 15 mg
n=89 Participants
DU-176b 15 mg tablets, oral once daily for 2 weeks
|
DU-176b 30 mg
n=85 Participants
DU-176b 30 mg tablets oral, once daily for 2 weeks
|
Enoxaparin Sodium 20mg (2000IU)
n=87 Participants
Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
|
|---|---|---|---|
|
Incidence of Major Bleeding or Clinically Relevant Non-major Bleedings.
|
2.2 percentage of subjects with bleeds
Interval 0.3 to 7.9
|
1.2 percentage of subjects with bleeds
Interval 0.0 to 6.4
|
2.3 percentage of subjects with bleeds
Interval 0.3 to 8.1
|
Adverse Events
DU-176b 15 mg
Serious events: 1 serious events
Other events: 58 other events
Deaths: 0 deaths
DU-176b 30 mg
Serious events: 2 serious events
Other events: 60 other events
Deaths: 0 deaths
Enoxaparin Sodium 20mg (2000IU)
Serious events: 1 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DU-176b 15 mg
n=89 participants at risk
DU-176b 15 mg tablets, oral once daily for 2 weeks
|
DU-176b 30 mg
n=85 participants at risk
DU-176b 30 mg tablets oral, once daily for 2 weeks
|
Enoxaparin Sodium 20mg (2000IU)
n=87 participants at risk
Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
dislocation of joint prothesis
|
1.1%
1/89 • Number of events 1
The Safety Analysis Set was 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
|
1.2%
1/85 • Number of events 1
The Safety Analysis Set was 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%
0/87
The Safety Analysis Set was 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
vertigo positional
|
0.00%
0/89
The Safety Analysis Set was 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
|
1.2%
1/85 • Number of events 1
The Safety Analysis Set was 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%
0/87
The Safety Analysis Set was 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
colitis
|
0.00%
0/89
The Safety Analysis Set was 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%
0/85
The Safety Analysis Set was 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
|
1.1%
1/87 • Number of events 1
The Safety Analysis Set was 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 15 mg
n=89 participants at risk
DU-176b 15 mg tablets, oral once daily for 2 weeks
|
DU-176b 30 mg
n=85 participants at risk
DU-176b 30 mg tablets oral, once daily for 2 weeks
|
Enoxaparin Sodium 20mg (2000IU)
n=87 participants at risk
Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
|
|---|---|---|---|
|
Investigations
blood urine present
|
9.0%
8/89 • Number of events 8
The Safety Analysis Set was 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
|
8.2%
7/85 • Number of events 9
The Safety Analysis Set was 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%
6/87 • Number of events 6
The Safety Analysis Set was 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 alkaline phosphatase increased
|
2.2%
2/89 • Number of events 2
The Safety Analysis Set was 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
|
3.5%
3/85 • Number of events 3
The Safety Analysis Set was 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%
9/87 • Number of events 9
The Safety Analysis Set was 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
|
|
Nervous system disorders
dizziness
|
0.00%
0/89
The Safety Analysis Set was 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
|
1.2%
1/85 • Number of events 1
The Safety Analysis Set was 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
|
4.6%
4/87 • Number of events 5
The Safety Analysis Set was 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
stomach discomfort
|
2.2%
2/89 • Number of events 2
The Safety Analysis Set was 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
|
2.4%
2/85 • Number of events 2
The Safety Analysis Set was 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%
3/87 • Number of events 3
The Safety Analysis Set was 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
vomiting
|
1.1%
1/89 • Number of events 1
The Safety Analysis Set was 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
|
3.5%
3/85 • Number of events 3
The Safety Analysis Set was 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
|
2.3%
2/87 • Number of events 2
The Safety Analysis Set was 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
rash
|
2.2%
2/89 • Number of events 2
The Safety Analysis Set was 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
|
3.5%
3/85 • Number of events 3
The Safety Analysis Set was 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
|
2.3%
2/87 • Number of events 2
The Safety Analysis Set was 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
|
|
Nervous system disorders
headache
|
4.5%
4/89 • Number of events 4
The Safety Analysis Set was 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
|
2.4%
2/85 • Number of events 2
The Safety Analysis Set was 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
|
5.7%
5/87 • Number of events 5
The Safety Analysis Set was 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
|
0.00%
0/89
The Safety Analysis Set was 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
|
1.2%
1/85 • Number of events 1
The Safety Analysis Set was 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
|
4.6%
4/87 • Number of events 5
The Safety Analysis Set was 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
|
2.2%
2/89 • Number of events 2
The Safety Analysis Set was 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
|
3.5%
3/85 • Number of events 3
The Safety Analysis Set was 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
|
4.6%
4/87 • Number of events 4
The Safety Analysis Set was 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
pruritis
|
4.5%
4/89 • Number of events 4
The Safety Analysis Set was 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
|
3.5%
3/85 • Number of events 3
The Safety Analysis Set was 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%
3/87 • Number of events 3
The Safety Analysis Set was 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 triglycerides increased
|
1.1%
1/89 • Number of events 1
The Safety Analysis Set was 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%
0/85
The Safety Analysis Set was 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
|
4.6%
4/87 • Number of events 4
The Safety Analysis Set was 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
abdominal pain upper
|
1.1%
1/89 • Number of events 1
The Safety Analysis Set was 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
|
3.5%
3/85 • Number of events 3
The Safety Analysis Set was 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%
0/87
The Safety Analysis Set was 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
|
5.6%
5/89 • Number of events 5
The Safety Analysis Set was 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
|
5.9%
5/85 • Number of events 5
The Safety Analysis Set was 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%
3/87 • Number of events 3
The Safety Analysis Set was 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
|
7.9%
7/89 • Number of events 7
The Safety Analysis Set was 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
|
5.9%
5/85 • Number of events 5
The Safety Analysis Set was 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%
6/87 • Number of events 6
The Safety Analysis Set was 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
|
3.4%
3/89 • Number of events 3
The Safety Analysis Set was 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
|
3.5%
3/85 • Number of events 3
The Safety Analysis Set was 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%
6/87 • Number of events 7
The Safety Analysis Set was 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
|
20.2%
18/89 • Number of events 18
The Safety Analysis Set was 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
|
9.4%
8/85 • Number of events 8
The Safety Analysis Set was 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
|
41.4%
36/87 • Number of events 36
The Safety Analysis Set was 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
|
7.9%
7/89 • Number of events 7
The Safety Analysis Set was 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
|
3.5%
3/85 • Number of events 3
The Safety Analysis Set was 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
|
28.7%
25/87 • Number of events 25
The Safety Analysis Set was 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
|
12.4%
11/89 • Number of events 11
The Safety Analysis Set was 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
|
16.5%
14/85 • Number of events 14
The Safety Analysis Set was 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
|
29.9%
26/87 • Number of events 26
The Safety Analysis Set was 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 exfoliation
|
1.1%
1/89 • Number of events 1
The Safety Analysis Set was 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
|
3.5%
3/85 • Number of events 3
The Safety Analysis Set was 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
|
1.1%
1/87 • Number of events 1
The Safety Analysis Set was 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 lactate dehydrogenase increased
|
2.2%
2/89 • Number of events 2
The Safety Analysis Set was 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%
0/85
The Safety Analysis Set was 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%
3/87 • Number of events 3
The Safety Analysis Set was 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
Masayuki Fukuzawa, Associate Director
Daiichi Sankyo.,LTD
Phone: 81-90-5584-2197
Email: [email protected]
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