Trial Outcomes & Findings for Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy (NCT NCT03176472)
NCT ID: NCT03176472
Last Updated: 2023-09-21
Results Overview
Difference between mean average pain intensity using the 11-point numerical pain rating scale (NRS) consisting of pain measurement from 0-10 with 10 being the worst pain and 0 being no pain at all.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
282 participants
Primary outcome timeframe
Baseline week [Day-7 to Day 1] compared to Final week [12 Weeks]
Results posted on
2023-09-21
Participant Flow
Participant milestones
| Measure |
Ricolinostat
Ricolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL)
ricolinostat: 120 mg per dose in 12 mL liquid formulation
|
Placebo
Placebo, 12 mL of liquid formulation with no active ingredient (i.e., ricolinostat), taken once daily (QD) by mouth
Placebo: 12 mL liquid formulation placebo
|
|---|---|---|
|
Double Blind Treatment Period
STARTED
|
142
|
140
|
|
Double Blind Treatment Period
COMPLETED
|
132
|
124
|
|
Double Blind Treatment Period
NOT COMPLETED
|
10
|
16
|
|
Open Label Extension
STARTED
|
131
|
121
|
|
Open Label Extension
COMPLETED
|
123
|
109
|
|
Open Label Extension
NOT COMPLETED
|
8
|
12
|
Reasons for withdrawal
| Measure |
Ricolinostat
Ricolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL)
ricolinostat: 120 mg per dose in 12 mL liquid formulation
|
Placebo
Placebo, 12 mL of liquid formulation with no active ingredient (i.e., ricolinostat), taken once daily (QD) by mouth
Placebo: 12 mL liquid formulation placebo
|
|---|---|---|
|
Double Blind Treatment Period
Withdrawal by Subject
|
5
|
10
|
|
Double Blind Treatment Period
Adverse Event
|
0
|
5
|
|
Double Blind Treatment Period
Lost to Follow-up
|
3
|
0
|
|
Double Blind Treatment Period
Physician Decision
|
0
|
1
|
|
Double Blind Treatment Period
Protocol Violation
|
1
|
0
|
|
Double Blind Treatment Period
Not Provided
|
1
|
0
|
|
Open Label Extension
Withdrawal by Subject
|
3
|
4
|
|
Open Label Extension
Adverse Event
|
2
|
4
|
|
Open Label Extension
Lost to Follow-up
|
1
|
2
|
|
Open Label Extension
Protocol Violation
|
0
|
1
|
|
Open Label Extension
Not Provided
|
2
|
1
|
Baseline Characteristics
Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
Ricolinostat
n=142 Participants
Ricolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL)
ricolinostat: 120 mg per dose in 12 mL liquid formulation
|
Placebo
n=140 Participants
Placebo, 12 mL of liquid formulation with no active ingredient (i.e., ricolinostat), taken once daily (QD) by mouth
Placebo: 12 mL liquid formulation placebo
|
Total
n=282 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 9.64 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 7.81 • n=7 Participants
|
60.2 years
STANDARD_DEVIATION 8.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
93 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Height
|
172.7 centimeters
STANDARD_DEVIATION 9.82 • n=5 Participants
|
173.1 centimeters
STANDARD_DEVIATION 9.91 • n=7 Participants
|
172.9 centimeters
STANDARD_DEVIATION 9.85 • n=5 Participants
|
|
Weight
|
93.7 Kg
STANDARD_DEVIATION 18.29 • n=5 Participants
|
96.76 Kg
STANDARD_DEVIATION 16.50 • n=7 Participants
|
95.22 Kg
STANDARD_DEVIATION 17.46 • n=5 Participants
|
|
Body Mass Index (BMI)
|
31.31 kg/m^2
STANDARD_DEVIATION 4.91 • n=5 Participants
|
32.21 kg/m^2
STANDARD_DEVIATION 4.17 • n=7 Participants
|
31.75 kg/m^2
STANDARD_DEVIATION 4.57 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline week [Day-7 to Day 1] compared to Final week [12 Weeks]Population: The number of subjects with non-missing values at both Baseline and specified visit.
Difference between mean average pain intensity using the 11-point numerical pain rating scale (NRS) consisting of pain measurement from 0-10 with 10 being the worst pain and 0 being no pain at all.
Outcome measures
| Measure |
Ricolinostat
n=140 Participants
Ricolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL)
ricolinostat: 120 mg per dose in 12 mL liquid formulation
|
Placebo
n=142 Participants
Placebo, 12 mL of liquid formulation with no active ingredient (i.e., ricolinostat), taken once daily (QD) by mouth
Placebo: 12 mL liquid formulation placebo
|
|---|---|---|
|
Change in Mean Average Pain Intensity (NRS)
|
-1.21 units on a scale
Standard Deviation 1.4
|
-1.03 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline week [Day-7 to Day 1] compared to Week 12Population: The number of subjects with non-missing values at both Baseline and specified visit.
Change in non-pain neuropathic signs utilizing the Utah Early Neuropathy Score (UENS) which is a physical examination-based scale designed to assess early sensory predominant polyneuropathy. Compared with other scales, the UENS emphasizes severity and spatial distribution of pin (sharp) sensation loss in the foot and leg and focuses less on motor weakness. The UENS utilizes a numeric scale from 0-42, with higher scores indicating greater disease severity.
Outcome measures
| Measure |
Ricolinostat
n=141 Participants
Ricolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL)
ricolinostat: 120 mg per dose in 12 mL liquid formulation
|
Placebo
n=139 Participants
Placebo, 12 mL of liquid formulation with no active ingredient (i.e., ricolinostat), taken once daily (QD) by mouth
Placebo: 12 mL liquid formulation placebo
|
|---|---|---|
|
Change in Non-pain Neuropathic Signs (UENS)
|
-1.51 units on a scale
Standard Deviation 0.39
|
-1.84 units on a scale
Standard Deviation 0.40
|
Adverse Events
Ricolinostat
Serious events: 6 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Open Label Extension
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ricolinostat
n=142 participants at risk
Ricolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL)
ricolinostat: 120 mg per dose in 12 mL liquid formulation
|
Placebo
n=140 participants at risk
Placebo, 12 mL of liquid formulation with no active ingredient (i.e., ricolinostat), taken once daily (QD) by mouth
Placebo: 12 mL liquid formulation placebo
|
Open Label Extension
n=252 participants at risk
Ricolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL)
ricolinostat: 120 mg per dose in 12 mL liquid formulation
|
|---|---|---|---|
|
Nervous system disorders
Complex Migraine
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Gastrointestinal disorders
Worsening diarrhea
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Skin and subcutaneous tissue disorders
WORSENING CHRONIC DERMATITIS
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Infections and infestations
Diverticulitis
|
0.70%
1/142 • Number of events 2 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Cardiac disorders
Proximal RCA Stenosis
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Ductal Breast Carcinoma
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.71%
1/140 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Injury, poisoning and procedural complications
NASAL BONE FRACTURE
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
General disorders
CHEST PAIN, NON-CARDIAC
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Cardiac disorders
ATRIAL TACHYCARDIA
|
0.00%
0/142 • Baseline through 24 weeks
|
0.71%
1/140 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Nervous system disorders
STROKE
|
0.00%
0/142 • Baseline through 24 weeks
|
0.71%
1/140 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Nervous system disorders
EPILEPTIC SEIZURES
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Cardiac disorders
CARDIAC ARREST EPISODES
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Vascular disorders
SEVERE SYMPTOMATIC ORTHOSTATIC SEVERE HYPOTENSION
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Metabolism and nutrition disorders
UNCONTROLED DIABETES
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Infections and infestations
RIGHT FOOT CELLULITIS
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Cardiac disorders
PROXIMAL LAD STENOSIS
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Injury, poisoning and procedural complications
LIVER LACERATION
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Injury, poisoning and procedural complications
LEFT KNEE WOUND CONTAMINATION
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Injury, poisoning and procedural complications
BILATERAL UPPER EXTREMITIES RECOVERED/RESOLVED ABRASIONS
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Injury, poisoning and procedural complications
RIGHT FLANK ABRASIONS
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Injury, poisoning and procedural complications
LEFT KNEE LACERATION
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Injury, poisoning and procedural complications
TONGUE LACERATION
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
BILATERAL LUNG CONSOLIDATION
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Infections and infestations
SURGICAL SITE INFECTION
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
Other adverse events
| Measure |
Ricolinostat
n=142 participants at risk
Ricolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL)
ricolinostat: 120 mg per dose in 12 mL liquid formulation
|
Placebo
n=140 participants at risk
Placebo, 12 mL of liquid formulation with no active ingredient (i.e., ricolinostat), taken once daily (QD) by mouth
Placebo: 12 mL liquid formulation placebo
|
Open Label Extension
n=252 participants at risk
Ricolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL)
ricolinostat: 120 mg per dose in 12 mL liquid formulation
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Eye disorders
Vision Blurred
|
0.00%
0/142 • Baseline through 24 weeks
|
0.71%
1/140 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/142 • Baseline through 24 weeks
|
0.71%
1/140 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.79%
2/252 • Number of events 2 • Baseline through 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
2.1%
3/142 • Number of events 3 • Baseline through 24 weeks
|
2.1%
3/140 • Number of events 3 • Baseline through 24 weeks
|
0.79%
2/252 • Number of events 2 • Baseline through 24 weeks
|
|
Gastrointestinal disorders
Difficulty Swallowing
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/142 • Baseline through 24 weeks
|
0.71%
1/140 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.1%
3/142 • Number of events 3 • Baseline through 24 weeks
|
2.9%
4/140 • Number of events 5 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Gastrointestinal disorders
Vomitting
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
2.1%
3/140 • Number of events 3 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
General disorders
Fatigue
|
0.00%
0/142 • Baseline through 24 weeks
|
1.4%
2/140 • Number of events 2 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Infections and infestations
Common Cold
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Investigations
Neutrophil Count Decreased
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/142 • Baseline through 24 weeks
|
0.71%
1/140 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
1.2%
3/252 • Number of events 3 • Baseline through 24 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
0.00%
0/142 • Baseline through 24 weeks
|
0.71%
1/140 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Nervous system disorders
Drowsiness
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Nervous system disorders
Dizziness
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/142 • Baseline through 24 weeks
|
0.71%
1/140 • Number of events 1 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Nervous system disorders
Facial Paralysis
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Renal and urinary disorders
Dysuria
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/142 • Baseline through 24 weeks
|
0.71%
1/140 • Number of events 2 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/142 • Baseline through 24 weeks
|
0.71%
1/140 • Number of events 2 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/142 • Baseline through 24 weeks
|
0.71%
1/140 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
|
Gastrointestinal disorders
Lymphocytic colitis
|
0.00%
0/142 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.40%
1/252 • Number of events 1 • Baseline through 24 weeks
|
|
Investigations
Thrombocytopenia
|
0.70%
1/142 • Number of events 1 • Baseline through 24 weeks
|
0.00%
0/140 • Baseline through 24 weeks
|
0.00%
0/252 • Baseline through 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60