Trial Outcomes & Findings for P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis (NCT NCT01708603)
NCT ID: NCT01708603
Last Updated: 2020-01-06
Results Overview
Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1831 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-01-06
Participant Flow
Participant milestones
| Measure |
210 mg Brodalumab
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
210 mg brodalumab: 210 mg brodalumab administered SC
|
140 mg Brodalumab
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
140 mg brodalumab: 140 mg brodalumab administered SC
|
Ustekinumab
Administered by subcutaneous (SC) injection per the labeled dosing regimen.
ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
|
Placebo
Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
210 mg brodalumab: 210 mg brodalumab administered SC
placebo: Placebo administered SC
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
612
|
610
|
300
|
309
|
|
Overall Study
COMPLETED
|
597
|
588
|
291
|
300
|
|
Overall Study
NOT COMPLETED
|
15
|
22
|
9
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
210 mg Brodalumab
n=612 Participants
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
210 mg brodalumab: 210 mg brodalumab administered SC
|
140 mg Brodalumab
n=610 Participants
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
140 mg brodalumab: 140 mg brodalumab administered SC
|
Ustekinumab
n=300 Participants
Administered by subcutaneous (SC) injection per the labeled dosing regimen.
ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
|
Placebo
n=309 Participants
Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
210 mg brodalumab: 210 mg brodalumab administered SC
placebo: Placebo administered SC
|
Total
n=1831 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
43.7 years
STANDARD_DEVIATION 12.9 • n=4 Participants
|
44.6 years
STANDARD_DEVIATION 12.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
191 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
573 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
421 Participants
n=5 Participants
|
413 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
219 Participants
n=4 Participants
|
1258 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
551 Participants
n=5 Participants
|
557 Participants
n=7 Participants
|
271 Participants
n=5 Participants
|
273 Participants
n=4 Participants
|
1652 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
64 participants
n=5 Participants
|
66 participants
n=7 Participants
|
32 participants
n=5 Participants
|
33 participants
n=4 Participants
|
195 participants
n=21 Participants
|
|
Region of Enrollment
Czechia
|
18 participants
n=5 Participants
|
20 participants
n=7 Participants
|
7 participants
n=5 Participants
|
8 participants
n=4 Participants
|
53 participants
n=21 Participants
|
|
Region of Enrollment
Netherlands
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
17 participants
n=21 Participants
|
|
Region of Enrollment
Austria
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
18 participants
n=5 Participants
|
15 participants
n=7 Participants
|
8 participants
n=5 Participants
|
10 participants
n=4 Participants
|
50 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
286 participants
n=5 Participants
|
281 participants
n=7 Participants
|
140 participants
n=5 Participants
|
144 participants
n=4 Participants
|
851 participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
130 participants
n=5 Participants
|
132 participants
n=7 Participants
|
65 participants
n=5 Participants
|
64 participants
n=4 Participants
|
391 participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
40 participants
n=5 Participants
|
39 participants
n=7 Participants
|
20 participants
n=5 Participants
|
19 participants
n=4 Participants
|
118 participants
n=21 Participants
|
|
Region of Enrollment
France
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
44 participants
n=21 Participants
|
|
Region of Enrollment
Portugal
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
4 participants
n=5 Participants
|
6 participants
n=4 Participants
|
32 participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
59 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksMeasures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear).
Outcome measures
| Measure |
210 mg Brodalumab
n=612 Participants
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
210 mg brodalumab: 210 mg brodalumab administered SC
|
140 mg Brodalumab
n=610 Participants
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
140 mg brodalumab: 140 mg brodalumab administered SC
|
Placebo
n=309 Participants
Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
210 mg brodalumab: 210 mg brodalumab administered SC
placebo: Placebo administered SC
|
Ustekinumab
n=300 Participants
Administered by subcutaneous (SC) injection until week 12. Participants using Ustekinumab were not rerandomized at week 12, and continued to receive ustekinumab.
|
|---|---|---|---|---|
|
Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
|
481 Participants
|
354 Participants
|
12 Participants
|
183 Participants
|
PRIMARY outcome
Timeframe: 12 weeksto evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12.
Outcome measures
| Measure |
210 mg Brodalumab
n=612 Participants
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
210 mg brodalumab: 210 mg brodalumab administered SC
|
140 mg Brodalumab
n=610 Participants
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
140 mg brodalumab: 140 mg brodalumab administered SC
|
Placebo
n=309 Participants
Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
210 mg brodalumab: 210 mg brodalumab administered SC
placebo: Placebo administered SC
|
Ustekinumab
n=300 Participants
Administered by subcutaneous (SC) injection until week 12. Participants using Ustekinumab were not rerandomized at week 12, and continued to receive ustekinumab.
|
|---|---|---|---|---|
|
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
|
528 Participants
|
406 Participants
|
25 Participants
|
210 Participants
|
PRIMARY outcome
Timeframe: 12 Weeksto evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.
Outcome measures
| Measure |
210 mg Brodalumab
n=612 Participants
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
210 mg brodalumab: 210 mg brodalumab administered SC
|
140 mg Brodalumab
n=610 Participants
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
140 mg brodalumab: 140 mg brodalumab administered SC
|
Placebo
n=309 Participants
Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
210 mg brodalumab: 210 mg brodalumab administered SC
placebo: Placebo administered SC
|
Ustekinumab
n=300 Participants
Administered by subcutaneous (SC) injection until week 12. Participants using Ustekinumab were not rerandomized at week 12, and continued to receive ustekinumab.
|
|---|---|---|---|---|
|
Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12
|
272 Participants
|
157 Participants
|
2 Participants
|
65 Participants
|
Adverse Events
210 mg Brodalumab
Serious events: 6 serious events
Other events: 354 other events
Deaths: 0 deaths
140 mg Brodalumab
Serious events: 13 serious events
Other events: 365 other events
Deaths: 0 deaths
Ustekinumab
Serious events: 4 serious events
Other events: 177 other events
Deaths: 0 deaths
Placebo
Serious events: 8 serious events
Other events: 165 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
210 mg Brodalumab
n=612 participants at risk
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
210 mg brodalumab: 210 mg brodalumab administered SC
|
140 mg Brodalumab
n=610 participants at risk
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
140 mg brodalumab: 140 mg brodalumab administered SC
|
Ustekinumab
n=300 participants at risk
Administered by subcutaneous (SC) injection per the labeled dosing regimen.
ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
|
Placebo
n=309 participants at risk
Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
210 mg brodalumab: 210 mg brodalumab administered SC
placebo: Placebo administered SC
|
|---|---|---|---|---|
|
General disorders
Drug Detoxification
|
0.00%
0/612
|
0.16%
1/610
|
0.00%
0/300
|
0.00%
0/309
|
|
Infections and infestations
Pancreatitis Acute
|
0.00%
0/612
|
0.16%
1/610
|
0.00%
0/300
|
0.32%
1/309
|
|
Infections and infestations
Appendicitis
|
0.16%
1/612
|
0.16%
1/610
|
0.00%
0/300
|
0.00%
0/309
|
|
Infections and infestations
Cellulitis
|
0.16%
1/612
|
0.16%
1/610
|
0.00%
0/300
|
0.00%
0/309
|
|
Blood and lymphatic system disorders
Blood Glucose Increased
|
0.00%
0/612
|
0.00%
0/610
|
0.00%
0/300
|
0.32%
1/309
|
|
General disorders
Diabetes Mellitus Inadequate Control
|
0.00%
0/612
|
0.00%
0/610
|
0.00%
0/300
|
0.32%
1/309
|
|
General disorders
Dysponea
|
0.00%
0/612
|
0.00%
0/610
|
0.00%
0/300
|
0.32%
1/309
|
|
Infections and infestations
Escherichia Urinary tract Infection
|
0.00%
0/612
|
0.00%
0/610
|
0.00%
0/300
|
0.32%
1/309
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/612
|
0.00%
0/610
|
0.00%
0/300
|
0.32%
1/309
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/612
|
0.00%
0/610
|
0.00%
0/300
|
0.32%
1/309
|
|
General disorders
Noncardiac Chest Pain
|
0.00%
0/612
|
0.00%
0/610
|
0.00%
0/300
|
0.32%
1/309
|
|
General disorders
Syncope
|
0.00%
0/612
|
0.00%
0/610
|
0.00%
0/300
|
0.32%
1/309
|
|
General disorders
Alcohol Abuse
|
0.16%
1/612
|
0.00%
0/610
|
0.00%
0/300
|
0.00%
0/309
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/612
|
0.16%
1/610
|
0.00%
0/300
|
0.00%
0/309
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/612
|
0.16%
1/610
|
0.00%
0/300
|
0.00%
0/309
|
|
Cardiac disorders
Anteriosclerosis
|
0.00%
0/612
|
0.16%
1/610
|
0.00%
0/300
|
0.00%
0/309
|
|
Injury, poisoning and procedural complications
Carbon Monoxide Poisining
|
0.16%
1/612
|
0.00%
0/610
|
0.00%
0/300
|
0.00%
0/309
|
|
Injury, poisoning and procedural complications
Cerbebral Infarction
|
0.16%
1/612
|
0.00%
0/610
|
0.00%
0/300
|
0.00%
0/309
|
|
General disorders
Chondromalacia
|
0.00%
0/612
|
0.16%
1/610
|
0.00%
0/300
|
0.00%
0/309
|
|
General disorders
Chondropathy
|
0.00%
0/612
|
0.16%
1/610
|
0.00%
0/300
|
0.00%
0/309
|
|
General disorders
Fibromyalgia
|
0.00%
0/612
|
0.16%
1/610
|
0.00%
0/300
|
0.00%
0/309
|
|
Vascular disorders
Hypertension
|
0.00%
0/612
|
0.16%
1/610
|
0.00%
0/300
|
0.00%
0/309
|
|
Injury, poisoning and procedural complications
Joint Capsule Rupture
|
0.00%
0/612
|
0.16%
1/610
|
0.00%
0/300
|
0.00%
0/309
|
|
Injury, poisoning and procedural complications
Ligament Injury
|
0.00%
0/612
|
0.16%
1/610
|
0.00%
0/300
|
0.00%
0/309
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/612
|
0.00%
0/610
|
0.33%
1/300
|
0.00%
0/309
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/612
|
0.00%
0/610
|
0.33%
1/300
|
0.00%
0/309
|
|
General disorders
Vertigo
|
0.00%
0/612
|
0.00%
0/610
|
0.33%
1/300
|
0.00%
0/309
|
|
Vascular disorders
Acute Coronary Syndrome
|
0.00%
0/612
|
0.00%
0/610
|
0.33%
1/300
|
0.00%
0/309
|
|
Psychiatric disorders
Suicide attempt
|
0.16%
1/612
|
0.00%
0/610
|
0.00%
0/300
|
0.00%
0/309
|
Other adverse events
| Measure |
210 mg Brodalumab
n=612 participants at risk
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
210 mg brodalumab: 210 mg brodalumab administered SC
|
140 mg Brodalumab
n=610 participants at risk
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
140 mg brodalumab: 140 mg brodalumab administered SC
|
Ustekinumab
n=300 participants at risk
Administered by subcutaneous (SC) injection per the labeled dosing regimen.
ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
|
Placebo
n=309 participants at risk
Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
210 mg brodalumab: 210 mg brodalumab administered SC
placebo: Placebo administered SC
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.4%
45/612
|
7.4%
45/610
|
6.0%
18/300
|
4.5%
14/309
|
|
Infections and infestations
Upper respiratory Tract infection
|
5.4%
33/612
|
4.9%
30/610
|
6.7%
20/300
|
7.4%
23/309
|
|
Infections and infestations
Bronchitis
|
2.0%
12/612
|
0.49%
3/610
|
1.3%
4/300
|
0.97%
3/309
|
|
Infections and infestations
Sinusitis
|
1.1%
7/612
|
0.49%
3/610
|
2.3%
7/300
|
0.97%
3/309
|
|
Infections and infestations
Urinary tract Infection
|
0.49%
3/612
|
1.3%
8/610
|
0.67%
2/300
|
1.3%
4/309
|
|
Infections and infestations
Influenza
|
1.1%
7/612
|
1.1%
7/610
|
0.33%
1/300
|
0.32%
1/309
|
|
Infections and infestations
Viral Upper respiratory Tract Infection
|
0.98%
6/612
|
0.82%
5/610
|
1.0%
3/300
|
0.00%
0/309
|
|
Infections and infestations
Gastroenteritis
|
0.49%
3/612
|
0.49%
3/610
|
0.67%
2/300
|
1.3%
4/309
|
|
Infections and infestations
Rhinitis
|
0.33%
2/612
|
0.49%
3/610
|
1.3%
4/300
|
0.65%
2/309
|
|
Infections and infestations
Pharyngitis
|
1.1%
7/612
|
0.49%
3/610
|
0.33%
1/300
|
0.00%
0/309
|
|
Infections and infestations
Folliculitis
|
1.1%
7/612
|
0.49%
3/610
|
0.33%
1/300
|
0.00%
0/309
|
|
Infections and infestations
Oral Herpes
|
0.33%
2/612
|
0.33%
2/610
|
1.3%
4/300
|
0.00%
0/309
|
|
Infections and infestations
Conjuncitvitus
|
0.33%
2/612
|
0.49%
3/610
|
0.33%
1/300
|
0.32%
1/309
|
|
Infections and infestations
Gastroenteritis Viral
|
0.16%
1/612
|
0.82%
5/610
|
0.00%
0/300
|
0.32%
1/309
|
|
Infections and infestations
Laryngitis
|
0.49%
3/612
|
0.33%
2/610
|
0.00%
0/300
|
0.32%
1/309
|
|
Infections and infestations
Tooth Infection
|
0.33%
2/612
|
0.16%
1/610
|
0.67%
2/300
|
0.32%
1/309
|
|
Infections and infestations
Otitis Media
|
0.65%
4/612
|
0.16%
1/610
|
0.33%
1/300
|
0.00%
0/309
|
|
Infections and infestations
Skin Infection
|
0.33%
2/612
|
0.49%
3/610
|
0.33%
1/300
|
0.00%
0/309
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.6%
28/612
|
5.4%
33/610
|
3.0%
9/300
|
3.9%
12/309
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.5%
9/612
|
2.8%
17/610
|
1.3%
4/300
|
0.97%
3/309
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.6%
10/612
|
1.5%
9/610
|
0.67%
2/300
|
1.9%
6/309
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.33%
2/612
|
0.33%
2/610
|
0.67%
2/300
|
0.00%
0/309
|
|
Musculoskeletal and connective tissue disorders
Psoriatic Arthropathy
|
0.65%
4/612
|
1.8%
11/610
|
0.00%
0/300
|
0.32%
1/309
|
|
Musculoskeletal and connective tissue disorders
Muskuloskelital Pain
|
0.82%
5/612
|
1.1%
7/610
|
0.33%
1/300
|
0.65%
2/309
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.65%
4/612
|
0.33%
2/610
|
0.33%
1/300
|
0.00%
0/309
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.49%
3/612
|
0.49%
3/610
|
0.33%
1/300
|
0.00%
0/309
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.82%
5/612
|
0.16%
1/610
|
0.00%
0/300
|
0.00%
0/309
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.16%
1/612
|
0.33%
2/610
|
1.0%
3/300
|
0.00%
0/309
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.33%
2/612
|
0.16%
1/610
|
0.67%
2/300
|
0.00%
0/309
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.16%
1/612
|
0.33%
2/610
|
0.00%
0/300
|
0.32%
1/309
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.49%
3/612
|
0.00%
0/610
|
0.33%
1/300
|
0.00%
0/309
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
12/612
|
2.1%
13/610
|
0.67%
2/300
|
1.3%
4/309
|
|
Gastrointestinal disorders
Nausea
|
1.8%
11/612
|
1.5%
9/610
|
1.7%
5/300
|
1.6%
5/309
|
|
Gastrointestinal disorders
Toothache
|
1.1%
7/612
|
0.98%
6/610
|
2.0%
6/300
|
1.3%
4/309
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.65%
4/612
|
1.3%
8/610
|
0.33%
1/300
|
1.3%
4/309
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.33%
2/612
|
1.6%
10/610
|
0.67%
2/300
|
0.32%
1/309
|
|
Gastrointestinal disorders
Dyspepsia
|
0.65%
4/612
|
0.82%
5/610
|
1.0%
3/300
|
0.32%
1/309
|
|
Gastrointestinal disorders
Vomiting
|
0.65%
4/612
|
0.66%
4/610
|
1.0%
3/300
|
0.32%
1/309
|
|
Gastrointestinal disorders
Dry Mouth
|
0.33%
2/612
|
0.82%
5/610
|
0.00%
0/300
|
0.32%
1/309
|
|
Gastrointestinal disorders
Constipation
|
0.16%
1/612
|
0.49%
3/610
|
0.67%
2/300
|
0.32%
1/309
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.3%
14/612
|
3.1%
19/610
|
2.0%
6/300
|
2.3%
7/309
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.49%
3/612
|
0.49%
3/610
|
0.67%
2/300
|
0.97%
3/309
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.98%
6/612
|
0.49%
3/610
|
0.67%
2/300
|
0.00%
0/309
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalized
|
0.33%
2/612
|
0.66%
4/610
|
0.33%
1/300
|
0.97%
3/309
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.33%
2/612
|
0.33%
2/610
|
1.0%
3/300
|
0.32%
1/309
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.33%
2/612
|
0.82%
5/610
|
0.33%
1/300
|
0.00%
0/309
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic Dermatitis
|
0.33%
2/612
|
0.66%
4/610
|
0.67%
2/300
|
0.00%
0/309
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.33%
2/612
|
0.49%
3/610
|
0.33%
1/300
|
0.00%
0/309
|
|
Nervous system disorders
headache
|
5.1%
31/612
|
5.7%
35/610
|
4.0%
12/300
|
2.9%
9/309
|
|
Nervous system disorders
Paraesthesia
|
0.49%
3/612
|
0.66%
4/610
|
0.67%
2/300
|
0.32%
1/309
|
|
Nervous system disorders
Sciatica
|
0.49%
3/612
|
0.82%
5/610
|
0.33%
1/300
|
0.32%
1/309
|
|
Nervous system disorders
Dizziness
|
0.49%
3/612
|
0.16%
1/610
|
0.33%
1/300
|
0.65%
2/309
|
|
Nervous system disorders
Migrane
|
0.33%
2/612
|
0.16%
1/610
|
0.67%
2/300
|
0.00%
0/309
|
|
Nervous system disorders
Sinus headache
|
0.33%
2/612
|
0.00%
0/610
|
0.00%
0/300
|
0.00%
0/309
|
|
General disorders
Fatigue
|
2.6%
16/612
|
1.8%
11/610
|
4.0%
12/300
|
0.65%
2/309
|
|
General disorders
Pyrexia
|
1.3%
8/612
|
0.98%
6/610
|
0.67%
2/300
|
0.00%
0/309
|
|
General disorders
Peripheral Swelling
|
0.65%
4/612
|
0.66%
4/610
|
0.00%
0/300
|
0.97%
3/309
|
|
General disorders
Asthenia
|
0.82%
5/612
|
0.98%
6/610
|
1.3%
4/300
|
0.32%
1/309
|
|
General disorders
Odema Peripheral
|
0.33%
2/612
|
0.33%
2/610
|
0.33%
1/300
|
1.3%
4/309
|
|
General disorders
Injection Site Pain
|
0.49%
3/612
|
0.82%
5/610
|
0.00%
0/300
|
0.32%
1/309
|
|
General disorders
Non-cardiac Chest Pain
|
0.00%
0/612
|
0.00%
0/610
|
0.33%
1/300
|
0.65%
2/309
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
2.1%
13/612
|
1.5%
9/610
|
1.0%
3/300
|
1.6%
5/309
|
|
Injury, poisoning and procedural complications
Laceration
|
0.16%
1/612
|
0.66%
4/610
|
1.0%
3/300
|
0.97%
3/309
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.16%
1/612
|
0.16%
1/610
|
0.00%
0/300
|
0.65%
2/309
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
1.6%
10/612
|
2.0%
12/610
|
0.33%
1/300
|
1.6%
5/309
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
7/612
|
0.82%
5/610
|
0.33%
1/300
|
1.9%
6/309
|
|
Respiratory, thoracic and mediastinal disorders
Hyperuricaemia
|
0.33%
2/612
|
0.49%
3/610
|
0.67%
2/300
|
1.3%
4/309
|
|
Metabolism and nutrition disorders
Gout
|
0.49%
3/612
|
0.49%
3/610
|
0.33%
1/300
|
0.97%
3/309
|
Additional Information
Study Director
Bausch Health
Phone: 510-259-5284
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60