Trial Outcomes & Findings for EZN-2279 in Patients With ADA-SCID (NCT NCT01420627)
NCT ID: NCT01420627
Last Updated: 2020-04-16
Results Overview
Number of patients with total erythrocyte dAXP concentration from a trough blood sample \<0.02 mmol/L
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
7 participants
Primary outcome timeframe
Baseline through Week T-21
Results posted on
2020-04-16
Participant Flow
Participant milestones
| Measure |
Adagen/EZN-2279
Patients started on Adagen and crossed over to experimental EZN-2279 treatment
|
|---|---|
|
Adagen Lead-in Period
STARTED
|
7
|
|
Adagen Lead-in Period
COMPLETED
|
7
|
|
Adagen Lead-in Period
NOT COMPLETED
|
0
|
|
EZN-2279 Treatment Period
STARTED
|
7
|
|
EZN-2279 Treatment Period
COMPLETED
|
6
|
|
EZN-2279 Treatment Period
NOT COMPLETED
|
1
|
|
EZN-2279 Maintenance Period
STARTED
|
6
|
|
EZN-2279 Maintenance Period
COMPLETED
|
6
|
|
EZN-2279 Maintenance Period
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Adagen/EZN-2279
Patients started on Adagen and crossed over to experimental EZN-2279 treatment
|
|---|---|
|
EZN-2279 Treatment Period
Adverse Event
|
1
|
Baseline Characteristics
EZN-2279 in Patients With ADA-SCID
Baseline characteristics by cohort
| Measure |
Adagen/EZN-2279
n=7 Participants
Patients started on Adagen and crossed over to experimental EZN-2279 treatment after at least a 3 week Lead-in Period on Adagen
EZN-2279: Weekly administration of EZN-2279 via IM injection
Adagen
|
|---|---|
|
Age, Continuous
|
21.3 years
STANDARD_DEVIATION 9.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week T-21Population: Completer
Number of patients with total erythrocyte dAXP concentration from a trough blood sample \<0.02 mmol/L
Outcome measures
| Measure |
EZN-2279
n=6 Participants
Patients received EZN-2279 following at least a 3-week Lead-in Period with Adagen
|
EZN-2279
Patients received EZN-2279 after crossing over from at least a 3 week Adagen Lead-in
|
|---|---|---|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period
Week T-15
|
6 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period
Week T-17
|
6 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period
Week T-19
|
6 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period
Week T-21
|
6 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period
Baseline
|
6 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period
Week T-1
|
6 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period
Week T-3
|
6 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period
Week T-5
|
5 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period
Week T-7
|
6 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period
Week T-8
|
6 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period
Week T-9
|
3 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period
Week T-10
|
5 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period
Week T-11
|
6 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period
Week T-13
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Through end of EZN-2279 study treatment, up to 203 weeksPopulation: As-treated
Summary of adverse events and serious adverse events
Outcome measures
| Measure |
EZN-2279
n=7 Participants
Patients received EZN-2279 following at least a 3-week Lead-in Period with Adagen
|
EZN-2279
n=7 Participants
Patients received EZN-2279 after crossing over from at least a 3 week Adagen Lead-in
|
|---|---|---|
|
Safety Summary Data
Patients with treatment-emergent adverse events
|
6 Participants
|
7 Participants
|
|
Safety Summary Data
Mild TEAE
|
4 Participants
|
1 Participants
|
|
Safety Summary Data
Moderate TEAE
|
2 Participants
|
3 Participants
|
|
Safety Summary Data
Severe TEAE
|
0 Participants
|
3 Participants
|
|
Safety Summary Data
Treatment-related adverse event
|
1 Participants
|
2 Participants
|
|
Safety Summary Data
Mild related AE
|
1 Participants
|
1 Participants
|
|
Safety Summary Data
Moderate related AE
|
0 Participants
|
0 Participants
|
|
Safety Summary Data
Severe related AE
|
0 Participants
|
1 Participants
|
|
Safety Summary Data
Patients with any SAE
|
0 Participants
|
4 Participants
|
|
Safety Summary Data
Patients discontinued treatment due to AE
|
0 Participants
|
1 Participants
|
|
Safety Summary Data
Non-serious AEs
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From Baseline through Week T-21Population: Completer
Trough ADA activity, mmol/h/L
Outcome measures
| Measure |
EZN-2279
n=6 Participants
Patients received EZN-2279 following at least a 3-week Lead-in Period with Adagen
|
EZN-2279
Patients received EZN-2279 after crossing over from at least a 3 week Adagen Lead-in
|
|---|---|---|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Baseline
|
15.7800 mmol/h/L
Interval 13.2 to 22.9
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Week T-1
|
14.0950 mmol/h/L
Interval 9.13 to 24.6
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-1
|
-1.7450 mmol/h/L
Interval -8.0 to 5.0
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Week T-3
|
23.3850 mmol/h/L
Interval 11.86 to 30.2
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-3
|
7.6500 mmol/h/L
Interval -4.06 to 9.36
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Week T-5
|
28.5600 mmol/h/L
Interval 25.9 to 33.04
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-5
|
13.3800 mmol/h/L
Interval 3.0 to 17.4
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Week T-7
|
34.8000 mmol/h/L
Interval 29.24 to 42.59
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-7
|
19.000 mmol/h/L
Interval 11.0 to 26.95
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Week T-8
|
32.9300 mmol/h/L
Interval 29.2 to 48.7
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-8
|
18.7400 mmol/h/L
Interval 6.3 to 29.1
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Week T-9
|
38.8750 mmol/h/L
Interval 26.16 to 52.8
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-9
|
24.6840 mmol/h/L
Interval 9.6 to 33.2
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Week T-10
|
37.7000 mmol/h/L
Interval 23.48 to 46.2
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Change from baseline at Week T-10
|
24.5000 mmol/h/L
Interval 6.1 to 28.28
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Week T-11
|
36.4350 mmol/h/L
Interval 19.29 to 44.85
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-11
|
21.1950 mmol/h/L
Interval 3.37 to 29.21
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Week T-13
|
36.1000 mmol/h/L
Interval 18.93 to 55.18
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-13
|
21.1150 mmol/h/L
Interval 3.01 to 39.54
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Week T-15
|
35.7850 mmol/h/L
Interval 26.15 to 43.3
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-15
|
20.3950 mmol/h/L
Interval 10.23 to 26.97
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Week T-17
|
31.1000 mmol/h/L
Interval 24.04 to 63.59
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-17
|
12.3500 mmol/h/L
Interval 8.12 to 47.95
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Week T-19
|
32.4200 mmol/h/L
Interval 24.35 to 55.03
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-19
|
14.4300 mmol/h/L
Interval 6.5 to 39.39
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Week T-21
|
30.1500 mmol/h/L
Interval 23.86 to 43.93
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-21
|
13.7500 mmol/h/L
Interval 5.3 to 28.29
|
—
|
SECONDARY outcome
Timeframe: Through end of EZN-2279 study treatment, up to 203 weeksPopulation: Completer
Trough ADA activity levels, mmol/h/L
Outcome measures
| Measure |
EZN-2279
n=6 Participants
Patients received EZN-2279 following at least a 3-week Lead-in Period with Adagen
|
EZN-2279
Patients received EZN-2279 after crossing over from at least a 3 week Adagen Lead-in
|
|---|---|---|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Baseline
|
15.7800 mmol/h/L
Interval 13.2 to 22.9
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Week 34
|
31.1000 mmol/h/L
Interval 16.4 to 51.8
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 34
|
14.0350 mmol/h/L
Interval 0.48 to 36.16
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Week 47
|
37.9000 mmol/h/L
Interval 16.17 to 42.23
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 47
|
21.2600 mmol/h/L
Interval 0.25 to 26.59
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Week 60
|
35.3100 mmol/h/L
Interval 13.44 to 50.77
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 60
|
20.1300 mmol/h/L
Interval -2.48 to 35.13
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Week 73
|
42.1900 mmol/h/L
Interval 31.25 to 47.55
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 73
|
22.5900 mmol/h/L
Interval 15.33 to 34.35
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Week 86
|
41.2000 mmol/h/L
Interval 24.87 to 54.96
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 86
|
25.5600 mmol/h/L
Interval 8.95 to 41.76
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Week 99
|
42.200 mmol/h/L
Interval 27.33 to 57.09
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 99
|
26.5800 mmol/h/L
Interval 4.43 to 37.49
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Week 112
|
31.6750 mmol/h/L
Interval 23.34 to 44.84
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 112
|
10.4250 mmol/h/L
Interval 7.42 to 31.64
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Week 125
|
39.2700 mmol/h/L
Interval 33.3 to 44.99
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 125
|
21.1150 mmol/h/L
Interval 11.19 to 31.79
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Week 138
|
46.0600 mmol/h/L
Interval 31.85 to 51.82
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 138
|
26.4600 mmol/h/L
Interval 8.95 to 38.62
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Week 151
|
36.6700 mmol/h/L
Interval 30.37 to 44.89
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 151
|
17.070 mmol/h/L
Interval 7.47 to 31.69
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Week 164
|
34.4500 mmol/h/L
Interval 27.95 to 41.99
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 164
|
11.5500 mmol/h/L
Interval 8.35 to 28.79
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Week 177
|
33.1300 mmol/h/L
Interval 26.98 to 47.85
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 177
|
13.5300 mmol/h/L
Interval 4.08 to 34.65
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Week 190
|
32.5000 mmol/h/L
Interval 31.18 to 38.92
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 190
|
11.5800 mmol/h/L
Interval 9.6 to 25.72
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Week 203
|
36.3300 mmol/h/L
Interval 33.89 to 43.31
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 203
|
16.7300 mmol/h/L
Interval 10.99 to 30.11
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
End of Study/Early Discontinuation
|
39.7700 mmol/h/L
Interval 33.74 to 46.17
|
—
|
|
Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period
Change from Baseline at End of Study/Early Discont
|
22.3800 mmol/h/L
Interval 10.84 to 30.53
|
—
|
SECONDARY outcome
Timeframe: From Baseline through Week T-21Population: Completer
Trough dAXP levels, mmol/L
Outcome measures
| Measure |
EZN-2279
n=6 Participants
Patients received EZN-2279 following at least a 3-week Lead-in Period with Adagen
|
EZN-2279
Patients received EZN-2279 after crossing over from at least a 3 week Adagen Lead-in
|
|---|---|---|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Baseline
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Week T-1
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-1
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Week T-3
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-3
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Week T-5
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-5
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Week T-7
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-7
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Week T-8
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-8
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Week T-9
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-9
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Week T-10
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-10
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Week T-11
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-11
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Week T-13
|
0.0020 mmol/L
Interval 0.002 to 0.032
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-13
|
0.0000 mmol/L
Interval 0.0 to 0.03
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Week T-15
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-15
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Week T-17
|
0.0020 mmol/L
Interval 0.002 to 0.047
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-17
|
0.0000 mmol/L
Interval 0.0 to 0.045
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Week T-19
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-19
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Week T-21
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Treatment Period
Change from Baseline at Week T-21
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: Through end of EZN-2279 study treatment, up to 203 weeksPopulation: Completer
Trough dAXP levels, mmol/L
Outcome measures
| Measure |
EZN-2279
n=6 Participants
Patients received EZN-2279 following at least a 3-week Lead-in Period with Adagen
|
EZN-2279
Patients received EZN-2279 after crossing over from at least a 3 week Adagen Lead-in
|
|---|---|---|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Baseline
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Week 34
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 34
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Week 47
|
0.0020 mmol/L
Interval 0.002 to 0.008
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 47
|
0.0000 mmol/L
Interval 0.0 to 0.006
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Week 60
|
0.0020 mmol/L
Interval 0.002 to 0.008
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 60
|
0.0000 mmol/L
Interval 0.0 to 0.006
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Week 73
|
0.0020 mmol/L
Interval 0.002 to 0.006
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 73
|
0.0000 mmol/L
Interval 0.0 to 0.004
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Week 86
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 86
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Week 99
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 99
|
0.000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Week 112
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 112
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Week 125
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 125
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Week 138
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 138
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Week 151
|
0.0020 mmol/L
Interval 0.002 to 0.005
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 151
|
0.0000 mmol/L
Interval 0.0 to 0.003
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Week 164
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 164
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Week 177
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 177
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Week 190
|
0.0020 mmol/L
Interval 0.002 to 0.002
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 190
|
0.0000 mmol/L
Interval 0.0 to 0.0
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Week 203
|
0.0020 mmol/L
Interval 0.002 to 0.008
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Change from Baseline at Week 203
|
0.0000 mmol/L
Interval 0.0 to 0.006
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
End of Study/Early Discontinuation
|
0.0020 mmol/L
Interval 0.002 to 0.01
|
—
|
|
Summary of Trough dAXP Levels in EZN-2279 Maintenance Period
Change from Baseline at End of Study/Early Discont
|
0.0000 mmol/L
Interval 0.0 to 0.008
|
—
|
SECONDARY outcome
Timeframe: Through end of EZN-2279 study treatment, up to 203 weeksPopulation: As-treated
Infections were documented clinically with signs and symptoms without microbiologic cultures or with positive viral or bacterial cultures
Outcome measures
| Measure |
EZN-2279
n=7 Participants
Patients received EZN-2279 following at least a 3-week Lead-in Period with Adagen
|
EZN-2279
Patients received EZN-2279 after crossing over from at least a 3 week Adagen Lead-in
|
|---|---|---|
|
Number of Patients With Infections and Hospitalizations
Patients with infection
|
5 Participants
|
—
|
|
Number of Patients With Infections and Hospitalizations
Patients with hospitalizations
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Through end of EZN-2279 study treatment, up to 203 weeksPopulation: As-treated population who were hospitalized
Outcome measures
| Measure |
EZN-2279
n=4 Number of hospitalizations (3 patients)
Patients received EZN-2279 following at least a 3-week Lead-in Period with Adagen
|
EZN-2279
Patients received EZN-2279 after crossing over from at least a 3 week Adagen Lead-in
|
|---|---|---|
|
Duration of Hospitalization
|
5.0 Days
Standard Deviation 2.16
|
—
|
SECONDARY outcome
Timeframe: From Week 34 to End of Study/Early Discontinuation, up to 203 weeksPopulation: Completer
Number of patients with total erythrocyte dAXP concentration from a trough blood sample \<0.02 mmol/L
Outcome measures
| Measure |
EZN-2279
n=6 Participants
Patients received EZN-2279 following at least a 3-week Lead-in Period with Adagen
|
EZN-2279
Patients received EZN-2279 after crossing over from at least a 3 week Adagen Lead-in
|
|---|---|---|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period
Week 47
|
6 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period
Week 60
|
3 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period
Week 73
|
5 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period
Week 86
|
5 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period
Baseline
|
6 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period
Week 34
|
6 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period
Week 99
|
5 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period
Week 112
|
4 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period
Week 125
|
4 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period
Week 138
|
3 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period
Week 151
|
3 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period
Week 164
|
3 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period
Week 177
|
3 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period
Week 190
|
3 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period
Week 203
|
3 Participants
|
—
|
|
Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period
End of Study/Early Discontinuation
|
3 Participants
|
—
|
Adverse Events
Adagen
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
EZN-2279
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adagen
n=7 participants at risk
Patients received Adagen during the Lead-in Period (at least 3 weeks)
|
EZN-2279
n=7 participants at risk
Patients received EZN-2279 after crossing over from Adagen
|
|---|---|---|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
General disorders
Injection site pain
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Nervous system disorders
Vestibular migraine
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
Other adverse events
| Measure |
Adagen
n=7 participants at risk
Patients received Adagen during the Lead-in Period (at least 3 weeks)
|
EZN-2279
n=7 participants at risk
Patients received EZN-2279 after crossing over from Adagen
|
|---|---|---|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
28.6%
2/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
28.6%
2/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
General disorders
Asthenia
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
General disorders
Chills
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
General disorders
Fatigue
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
General disorders
Gait disturbance
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
General disorders
Injection site bruising
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
General disorders
Injection site discomfort
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
General disorders
Injection site pain
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
General disorders
Malaise
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
General disorders
Nodule
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
General disorders
Peripheral swelling
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
42.9%
3/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
28.6%
2/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
28.6%
2/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Gastrointestinal disorders
Anogenital dysplasia
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
28.6%
2/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Alveolar osteitis
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Candida infection
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Ear lobe infection
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Groin abscess
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Otitis externa
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Respiratory tract infection
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Epidermodysplasia verruciformis
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Infections and infestations
Gastroenteritis
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
42.9%
3/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
28.6%
2/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
28.6%
2/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
28.6%
2/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Nervous system disorders
Sciatica
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Nervous system disorders
Vestibular migraine
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
28.6%
2/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Investigations
Blood immunoglobulin G increased
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Investigations
Immunoglobulins increased
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Investigations
Monoclonal immunoglobulin present
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Investigations
Crystal urine present
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Investigations
Full blood count abnormal
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Reproductive system and breast disorders
Scrotal mass
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
|
Vascular disorders
Superior vena cava stenosis
|
0.00%
0/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
14.3%
1/7 • Through end of EZN-2279 study treatment, up to 203 weeks
|
Additional Information
Scott Rodgers, MS, CCRA, ACRP-PM / Sr Director Clinical Operations
Leadiant Biosciences, Inc.
Phone: 301-670-1565
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60