Trial Outcomes & Findings for Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis (NCT NCT00658788)
NCT ID: NCT00658788
Last Updated: 2022-08-23
Results Overview
Success was defined as a one-grade improvement in ODS from baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
305 participants
Primary outcome timeframe
8 and 12 weeks
Results posted on
2022-08-23
Participant Flow
Participant milestones
| Measure |
Sequential Treatment Regimen
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
|
|---|---|
|
Overall Study
STARTED
|
305
|
|
Overall Study
COMPLETED
|
231
|
|
Overall Study
NOT COMPLETED
|
74
|
Reasons for withdrawal
| Measure |
Sequential Treatment Regimen
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
|
|---|---|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Withdrawal by Subject
|
13
|
|
Overall Study
Lost to Follow-up
|
18
|
|
Overall Study
Treatment Discontinuation
|
32
|
Baseline Characteristics
Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Sequential Treatment Regimen
n=305 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
|
|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
187 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
278 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 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
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
273 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 and 12 weeksPopulation: The per protocol population included 170 subjects who completed the 12 week regimen without any major protocol deviations.
Success was defined as a one-grade improvement in ODS from baseline.
Outcome measures
| Measure |
Sequential Treatment Regimen
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 4
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 8
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
|---|---|---|---|---|---|
|
Overall Disease Severity Success (ODS)
Week 12
|
84.1 percentage of participants
Interval 77.7 to 89.3
|
—
|
—
|
—
|
—
|
|
Overall Disease Severity Success (ODS)
Week 8
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2, 4, 8 and 12 weeksOutcome measures
| Measure |
Sequential Treatment Regimen
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 4
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 8
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
|---|---|---|---|---|---|
|
Global Improvement Score
-1:Symptoms
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Global Improvement Score
0:No Change
|
4 participants
|
2 participants
|
10 participants
|
13 participants
|
—
|
|
Global Improvement Score
1:Minimal Improvement
|
9 participants
|
4 participants
|
12 participants
|
19 participants
|
—
|
|
Global Improvement Score
2:Definite Improvement
|
53 participants
|
26 participants
|
43 participants
|
49 participants
|
—
|
|
Global Improvement Score
3:Considerable Improvement
|
93 participants
|
96 participants
|
77 participants
|
58 participants
|
—
|
|
Global Improvement Score
4:Clearing
|
11 participants
|
42 participants
|
28 participants
|
31 participants
|
—
|
SECONDARY outcome
Timeframe: 2, 4, 8 and 12 weeksOutcome measures
| Measure |
Sequential Treatment Regimen
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 4
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 8
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
|---|---|---|---|---|---|
|
Signs of Psoriasis - Erythema
Clear
|
0 participants
|
9 participants
|
13 participants
|
12 participants
|
—
|
|
Signs of Psoriasis - Erythema
Almost Clear
|
46 participants
|
81 participants
|
53 participants
|
41 participants
|
—
|
|
Signs of Psoriasis - Erythema
Mild
|
82 participants
|
57 participants
|
70 participants
|
60 participants
|
—
|
|
Signs of Psoriasis - Erythema
Moderate
|
35 participants
|
23 participants
|
32 participants
|
53 participants
|
—
|
|
Signs of Psoriasis - Erythema
Severe/Very Severe
|
7 participants
|
0 participants
|
2 participants
|
4 participants
|
—
|
SECONDARY outcome
Timeframe: 2, 4, 8 and 12 weeksOutcome measures
| Measure |
Sequential Treatment Regimen
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 4
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 8
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
|---|---|---|---|---|---|
|
Signs of Psoriasis - Scaling
Clear
|
25 participants
|
41 participants
|
36 participants
|
31 participants
|
—
|
|
Signs of Psoriasis - Scaling
Almost Clear
|
61 participants
|
83 participants
|
53 participants
|
56 participants
|
—
|
|
Signs of Psoriasis - Scaling
Mild
|
63 participants
|
37 participants
|
71 participants
|
54 participants
|
—
|
|
Signs of Psoriasis - Scaling
Moderate
|
19 participants
|
9 participants
|
9 participants
|
26 participants
|
—
|
|
Signs of Psoriasis - Scaling
Severe/Very Severe
|
4 participants
|
0 participants
|
1 participants
|
3 participants
|
—
|
SECONDARY outcome
Timeframe: 2, 4, 8 and 12 weeksOutcome measures
| Measure |
Sequential Treatment Regimen
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 4
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 8
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
|---|---|---|---|---|---|
|
Signs of Psoriasis - Plaque Elevation
Clear
|
22 participants
|
46 participants
|
35 participants
|
24 participants
|
—
|
|
Signs of Psoriasis - Plaque Elevation
Almost Clear
|
69 participants
|
78 participants
|
50 participants
|
45 participants
|
—
|
|
Signs of Psoriasis - Plaque Elevation
Mild
|
54 participants
|
36 participants
|
68 participants
|
61 participants
|
—
|
|
Signs of Psoriasis - Plaque Elevation
Moderate
|
24 participants
|
9 participants
|
17 participants
|
39 participants
|
—
|
|
Signs of Psoriasis - Plaque Elevation
Severe/Very Severe
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: 2, 4, 8 and 12 weeksOutcome measures
| Measure |
Sequential Treatment Regimen
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 4
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 8
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Body Surface Area (% BSA) Affected
|
20.1 Percent Change from Baseline
Standard Deviation 23.6
|
43.1 Percent Change from Baseline
Standard Deviation 30.9
|
46.6 Percent Change from Baseline
Standard Deviation 31.1
|
46.2 Percent Change from Baseline
Standard Deviation 36.1
|
—
|
SECONDARY outcome
Timeframe: 2, 4, 8 and 12 weeksOutcome measures
| Measure |
Sequential Treatment Regimen
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 4
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 8
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
n=170 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
|---|---|---|---|---|---|
|
Overall Disease Severity
Clear
|
0 participants
|
5 participants
|
9 participants
|
11 participants
|
—
|
|
Overall Disease Severity
Almost Clear
|
53 participants
|
100 participants
|
60 participants
|
45 participants
|
—
|
|
Overall Disease Severity
Mild
|
83 participants
|
53 participants
|
88 participants
|
70 participants
|
—
|
|
Overall Disease Severity
Moderate
|
31 participants
|
12 participants
|
13 participants
|
44 participants
|
—
|
|
Overall Disease Severity
Severe/Very Severe
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, 8 and 12 weeksOutcome measures
| Measure |
Sequential Treatment Regimen
n=305 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 4
n=288 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 8
n=285 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
n=274 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
n=235 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
|---|---|---|---|---|---|
|
Tolerability Assessment - Pruritus
None
|
74 participants
|
179 participants
|
220 participants
|
172 participants
|
128 participants
|
|
Tolerability Assessment - Pruritus
Mild
|
84 participants
|
91 participants
|
56 participants
|
66 participants
|
65 participants
|
|
Tolerability Assessment - Pruritus
Moderate
|
84 participants
|
13 participants
|
9 participants
|
31 participants
|
32 participants
|
|
Tolerability Assessment - Pruritus
Severe
|
63 participants
|
5 participants
|
0 participants
|
5 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, 8 and 12 weeksOutcome measures
| Measure |
Sequential Treatment Regimen
n=305 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 4
n=288 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 8
n=285 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
n=274 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
n=235 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
|---|---|---|---|---|---|
|
Tolerability Assessment - Telangiectasias
None
|
303 participants
|
284 participants
|
283 participants
|
273 participants
|
230 participants
|
|
Tolerability Assessment - Telangiectasias
Mild
|
1 participants
|
4 participants
|
2 participants
|
1 participants
|
5 participants
|
|
Tolerability Assessment - Telangiectasias
Moderate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Tolerability Assessment - Telangiectasias
Severe
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, 8 and 12 weeksOutcome measures
| Measure |
Sequential Treatment Regimen
n=305 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 4
n=288 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 8
n=285 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
n=274 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
n=235 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
|---|---|---|---|---|---|
|
Tolerability Assessment - Stinging/ Burning
None
|
200 participants
|
232 participants
|
245 participants
|
234 participants
|
200 participants
|
|
Tolerability Assessment - Stinging/ Burning
Mild
|
44 participants
|
42 participants
|
34 participants
|
18 participants
|
24 participants
|
|
Tolerability Assessment - Stinging/ Burning
Moderate
|
31 participants
|
13 participants
|
4 participants
|
19 participants
|
8 participants
|
|
Tolerability Assessment - Stinging/ Burning
Severe
|
30 participants
|
1 participants
|
1 participants
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, 8 and 12 weeksOutcome measures
| Measure |
Sequential Treatment Regimen
n=305 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 4
n=288 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 8
n=285 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
n=274 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
n=235 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
|---|---|---|---|---|---|
|
Tolerability Assessment - Skin Atrophy
Absent
|
303 participants
|
286 participants
|
278 participants
|
270 participants
|
233 participants
|
|
Tolerability Assessment - Skin Atrophy
Present
|
2 participants
|
2 participants
|
7 participants
|
4 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, 8 and 12 weeksOutcome measures
| Measure |
Sequential Treatment Regimen
n=305 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 4
n=288 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 8
n=285 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
n=274 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
Week 12
n=235 Participants
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
|
|---|---|---|---|---|---|
|
Tolerability Assessment - Folliculitis
Absent
|
303 participants
|
286 participants
|
274 participants
|
271 participants
|
232 participants
|
|
Tolerability Assessment - Folliculitis
Present
|
2 participants
|
2 participants
|
11 participants
|
3 participants
|
3 participants
|
Adverse Events
Sequential Treatment Regimen
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sequential Treatment Regimen
n=305 participants at risk
4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
|
|---|---|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.33%
1/305
|
|
Injury, poisoning and procedural complications
Fall
|
0.33%
1/305
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.33%
1/305
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.33%
1/305
|
|
Infections and infestations
Pneumonia
|
0.33%
1/305
|
|
Nervous system disorders
Hemiplegia
|
0.33%
1/305
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.33%
1/305
|
|
Psychiatric disorders
Bipolar disorder
|
0.33%
1/305
|
|
Psychiatric disorders
Depression
|
0.33%
1/305
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60