Trial Outcomes & Findings for A Study of E6011 in Japanese Subjects With Rheumatoid Arthritis (NCT NCT02196558)
NCT ID: NCT02196558
Last Updated: 2020-08-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Up to 52 Weeks
Results posted on
2020-08-13
Participant Flow
Participants took part in the study at 13 investigative sites in Japan from 26 May 2014 to 13 July 2017. As planned separate pharmacokinetics (PK) parameters are not reported and PK analyses was performed for serum E6011 concentrations. Also as planned, combined data for Treatment Phase and Expansion Phase is reported.
Total 53 participants were enrolled and screened, of which 16 were screen failures, 37 participants received study drug in 12-week Treatment Phase. Out of them, 32 participants completed 12-week Treatment Phase. Of 32 participants, 28 participants entered Extension Phase, 22 completed 40-week Extension Phase. '\>='signifies greater than or equal to.
Participant milestones
| Measure |
E6011: 100 mg
Participants received E6011 100 milligram (mg), subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to Week 10 in Treatment Phase and continued to receive E6011 100 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
E6011: 200 mg
Participants received E6011 200 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 200 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
E6011: 400 mg
Participants received E6011 400 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 400 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
|---|---|---|---|
|
Treatment Phase (12 Weeks)
STARTED
|
12
|
15
|
10
|
|
Treatment Phase (12 Weeks)
COMPLETED
|
12
|
12
|
8
|
|
Treatment Phase (12 Weeks)
NOT COMPLETED
|
0
|
3
|
2
|
|
Extension Phase (40 Weeks)
STARTED
|
11
|
11
|
6
|
|
Extension Phase (40 Weeks)
COMPLETED
|
9
|
8
|
5
|
|
Extension Phase (40 Weeks)
NOT COMPLETED
|
2
|
3
|
1
|
Reasons for withdrawal
| Measure |
E6011: 100 mg
Participants received E6011 100 milligram (mg), subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to Week 10 in Treatment Phase and continued to receive E6011 100 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
E6011: 200 mg
Participants received E6011 200 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 200 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
E6011: 400 mg
Participants received E6011 400 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 400 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
|---|---|---|---|
|
Treatment Phase (12 Weeks)
Adverse Event
|
0
|
2
|
0
|
|
Treatment Phase (12 Weeks)
Participant Choice
|
0
|
1
|
1
|
|
Treatment Phase (12 Weeks)
Progression of Disease
|
0
|
0
|
1
|
|
Extension Phase (40 Weeks)
Adverse Event
|
1
|
2
|
0
|
|
Extension Phase (40 Weeks)
Inadequate therapeutic effect
|
1
|
1
|
1
|
Baseline Characteristics
A Study of E6011 in Japanese Subjects With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
E6011: 100 mg
n=12 Participants
Participants received E6011 100 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to Week 10 in Treatment Phase and continued to receive E6011 100 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
E6011: 200 mg
n=15 Participants
Participants received E6011 200 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 200 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
E6011: 400 mg
n=10 Participants
Participants received E6011 400 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 400 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 8.95 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 12.02 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 8.28 • n=5 Participants
|
49.5 years
STANDARD_DEVIATION 10.03 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (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
|
|
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
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
37 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
|
PRIMARY outcome
Timeframe: Up to 52 WeeksPopulation: The safety analysis set included group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
Outcome measures
| Measure |
E6011: 100 mg
n=12 Participants
Participants received E6011 100 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to Week 10 in Treatment Phase and continued to receive E6011 100 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
E6011: 200 mg
n=15 Participants
Participants received E6011 200 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 200 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
E6011: 400 mg
n=10 Participants
Participants received E6011 400 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 400 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
10 Participants
|
14 Participants
|
7 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
1 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: The safety analysis set included group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here, "number analyzed" signifies the participants who were evaluable for this outcome measure for given time points.
Outcome measures
| Measure |
E6011: 100 mg
n=12 Participants
Participants received E6011 100 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to Week 10 in Treatment Phase and continued to receive E6011 100 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
E6011: 200 mg
n=15 Participants
Participants received E6011 200 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 200 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
E6011: 400 mg
n=10 Participants
Participants received E6011 400 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 400 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
|---|---|---|---|
|
Number of Participants With Positive Anti-E6011 Antibodies Results
Treatment Phase (12 Weeks)
|
9 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Positive Anti-E6011 Antibodies Results
Extension Phase (40 Weeks)
|
9 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Week 0 (predose), Week 1, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (postdose)Population: The pharmacokinetics (PK) analysis set included group of participants who received at least 1 dose of study drug and had at least 1 serum E6011 concentration data. Here, "number analyzed" signifies the participants who were evaluable for this outcome measure for given time points.
Outcome measures
| Measure |
E6011: 100 mg
n=12 Participants
Participants received E6011 100 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to Week 10 in Treatment Phase and continued to receive E6011 100 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
E6011: 200 mg
n=15 Participants
Participants received E6011 200 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 200 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
E6011: 400 mg
n=10 Participants
Participants received E6011 400 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 400 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
|---|---|---|---|
|
Serum Concentrations of E6011
Week 0 (predose)
|
0.00 mcg/ml (microgram per milliliter)
Standard Deviation 0.00
|
0.00 mcg/ml (microgram per milliliter)
Standard Deviation 0.00
|
0.00 mcg/ml (microgram per milliliter)
Standard Deviation 0.00
|
|
Serum Concentrations of E6011
Week 1
|
8.12 mcg/ml (microgram per milliliter)
Standard Deviation 3.06
|
20.0 mcg/ml (microgram per milliliter)
Standard Deviation 9.11
|
39.9 mcg/ml (microgram per milliliter)
Standard Deviation 13.6
|
|
Serum Concentrations of E6011
Week 2
|
15.7 mcg/ml (microgram per milliliter)
Standard Deviation 6.30
|
37.1 mcg/ml (microgram per milliliter)
Standard Deviation 11.9
|
73.9 mcg/ml (microgram per milliliter)
Standard Deviation 20.7
|
|
Serum Concentrations of E6011
Week 4
|
15.6 mcg/ml (microgram per milliliter)
Standard Deviation 6.75
|
38.8 mcg/ml (microgram per milliliter)
Standard Deviation 16.6
|
80.9 mcg/ml (microgram per milliliter)
Standard Deviation 28.7
|
|
Serum Concentrations of E6011
Week 6
|
12.5 mcg/ml (microgram per milliliter)
Standard Deviation 6.04
|
34.8 mcg/ml (microgram per milliliter)
Standard Deviation 16.6
|
82.1 mcg/ml (microgram per milliliter)
Standard Deviation 27.9
|
|
Serum Concentrations of E6011
Week 8
|
12.4 mcg/ml (microgram per milliliter)
Standard Deviation 7.17
|
35.1 mcg/ml (microgram per milliliter)
Standard Deviation 20.4
|
84.1 mcg/ml (microgram per milliliter)
Standard Deviation 31.3
|
|
Serum Concentrations of E6011
Week 10
|
12.9 mcg/ml (microgram per milliliter)
Standard Deviation 8.20
|
29.2 mcg/ml (microgram per milliliter)
Standard Deviation 11.1
|
90.7 mcg/ml (microgram per milliliter)
Standard Deviation 38.0
|
|
Serum Concentrations of E6011
Week 12
|
11.6 mcg/ml (microgram per milliliter)
Standard Deviation 7.02
|
31.2 mcg/ml (microgram per milliliter)
Standard Deviation 11.9
|
90.7 mcg/ml (microgram per milliliter)
Standard Deviation 39.7
|
|
Serum Concentrations of E6011
Week 16
|
14.4 mcg/ml (microgram per milliliter)
Standard Deviation 6.33
|
28.2 mcg/ml (microgram per milliliter)
Standard Deviation 11.2
|
111 mcg/ml (microgram per milliliter)
Standard Deviation 28.1
|
|
Serum Concentrations of E6011
Week 20
|
14.6 mcg/ml (microgram per milliliter)
Standard Deviation 6.97
|
30.6 mcg/ml (microgram per milliliter)
Standard Deviation 10.9
|
103 mcg/ml (microgram per milliliter)
Standard Deviation 37.6
|
|
Serum Concentrations of E6011
Week 24
|
13.7 mcg/ml (microgram per milliliter)
Standard Deviation 7.76
|
30.5 mcg/ml (microgram per milliliter)
Standard Deviation 12.6
|
116 mcg/ml (microgram per milliliter)
Standard Deviation 26.0
|
|
Serum Concentrations of E6011
Week 28
|
13.8 mcg/ml (microgram per milliliter)
Standard Deviation 8.33
|
33.6 mcg/ml (microgram per milliliter)
Standard Deviation 11.6
|
98.3 mcg/ml (microgram per milliliter)
Standard Deviation 31.1
|
|
Serum Concentrations of E6011
Week 32
|
15.1 mcg/ml (microgram per milliliter)
Standard Deviation 6.25
|
31.4 mcg/ml (microgram per milliliter)
Standard Deviation 12.4
|
106 mcg/ml (microgram per milliliter)
Standard Deviation 30.7
|
|
Serum Concentrations of E6011
Week 36
|
14.0 mcg/ml (microgram per milliliter)
Standard Deviation 7.23
|
31.6 mcg/ml (microgram per milliliter)
Standard Deviation 13.4
|
108 mcg/ml (microgram per milliliter)
Standard Deviation 32.4
|
|
Serum Concentrations of E6011
Week 40
|
14.6 mcg/ml (microgram per milliliter)
Standard Deviation 8.90
|
39.2 mcg/ml (microgram per milliliter)
Standard Deviation 11.5
|
113 mcg/ml (microgram per milliliter)
Standard Deviation 30.2
|
|
Serum Concentrations of E6011
Week 44
|
13.2 mcg/ml (microgram per milliliter)
Standard Deviation 7.56
|
40.4 mcg/ml (microgram per milliliter)
Standard Deviation 15.5
|
112 mcg/ml (microgram per milliliter)
Standard Deviation 37.9
|
|
Serum Concentrations of E6011
Week 48
|
14.6 mcg/ml (microgram per milliliter)
Standard Deviation 8.43
|
37.5 mcg/ml (microgram per milliliter)
Standard Deviation 19.0
|
111 mcg/ml (microgram per milliliter)
Standard Deviation 32.9
|
|
Serum Concentrations of E6011
Week 52
|
16.2 mcg/ml (microgram per milliliter)
Standard Deviation 11.2
|
37.0 mcg/ml (microgram per milliliter)
Standard Deviation 12.7
|
111 mcg/ml (microgram per milliliter)
Standard Deviation 41.1
|
Adverse Events
E6011: 100 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
E6011: 200 mg
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
E6011: 400 mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E6011: 100 mg
n=12 participants at risk
Participants received E6011 100 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to Week 10 in Treatment Phase and continued to receive E6011 100 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
E6011: 200 mg
n=15 participants at risk
Participants received E6011 200 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 200 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
E6011: 400 mg
n=10 participants at risk
Participants received E6011 400 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 400 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
|---|---|---|---|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
10.0%
1/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Metabolism and nutrition disorders
Latent autoimmune diabetes in adults
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
Other adverse events
| Measure |
E6011: 100 mg
n=12 participants at risk
Participants received E6011 100 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to Week 10 in Treatment Phase and continued to receive E6011 100 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
E6011: 200 mg
n=15 participants at risk
Participants received E6011 200 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 200 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
E6011: 400 mg
n=10 participants at risk
Participants received E6011 400 mg, subcutaneously, injection, at Week 0, 1, 2, followed by every 2 weeks up to 10 weeks in Treatment Phase and continued to receive E6011 400 mg, subcutaneously, injection, at every two weeks in Extension Phase (for a total of 52 weeks \[Treatment Phase of 12 Weeks and Extension Phase of 40 Weeks\]).
|
|---|---|---|---|
|
Infections and infestations
Cystitis
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
13.3%
2/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
10.0%
1/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
13.3%
2/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
13.3%
2/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
General disorders
Injection site erythema
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
20.0%
2/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
General disorders
Chest discomfort
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
10.0%
1/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
10.0%
1/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
41.7%
5/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
46.7%
7/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
40.0%
4/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Pharyngitis
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
10.0%
1/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
10.0%
1/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Gastric infection
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
10.0%
1/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Influenza
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
10.0%
1/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Injury, poisoning and procedural complications
Limb injury
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Investigations
Blood beta-D-glucan increased
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Investigations
Blood lactate dehydrogenase increased
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Investigations
Blood urine present
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Investigations
Candida test positive
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Investigations
Cell marker increased
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
13.3%
2/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
10.0%
1/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoproliferative disorder
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
10.0%
1/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
10.0%
1/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Nervous system disorders
Hypoaesthesia
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Nervous system disorders
Syncope
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
2/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
13.3%
2/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
10.0%
1/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/12 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
6.7%
1/15 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
0.00%
0/10 • Up to 52 Weeks
As planned, combined safety data for E6011 administered in Treatment phase and Extension phase was reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place