Trial Outcomes & Findings for A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004) (NCT NCT03285490)
NCT ID: NCT03285490
Last Updated: 2021-03-10
Results Overview
Complete clearance rate was defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
351 participants
Primary outcome timeframe
Day 57
Results posted on
2021-03-10
Participant Flow
The study was conducted at 31 sites in the United States between 15-September-2017 to 24-April-2019.
A total of 410 participants were screened, of which 351 participants were enrolled, 173 were randomized to vehicle control (118 face, 55 scalp) and 178 to KX2-391 ointment 1 percent (%) (119 face, 59 scalp). This study consisted of 2 periods i.e., Treatment and response assessment period (Baseline up to Day 57) followed by Recurrence follow-up period (12 months post-Day 57).
Participant milestones
| Measure |
Placebo
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 centimeter square (cm\^2) on face or scalp.
|
KX2-391 Ointment 1%
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
|---|---|---|
|
Treatment and Response Assessment Period
STARTED
|
173
|
178
|
|
Treatment and Response Assessment Period
COMPLETED
|
173
|
178
|
|
Treatment and Response Assessment Period
NOT COMPLETED
|
0
|
0
|
|
Recurrence Follow-up Period
STARTED
|
22
|
97
|
|
Recurrence Follow-up Period
COMPLETED
|
4
|
36
|
|
Recurrence Follow-up Period
NOT COMPLETED
|
18
|
61
|
Reasons for withdrawal
| Measure |
Placebo
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 centimeter square (cm\^2) on face or scalp.
|
KX2-391 Ointment 1%
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
|---|---|---|
|
Recurrence Follow-up Period
Withdrawal by Subject
|
0
|
1
|
|
Recurrence Follow-up Period
AK recurrence during Recurrence Follow-Up Period
|
18
|
60
|
Baseline Characteristics
A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)
Baseline characteristics by cohort
| Measure |
Placebo
n=173 Participants
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
KX2-391 Ointment 1%
n=178 Participants
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
Total
n=351 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.2 years
STANDARD_DEVIATION 8.86 • n=5 Participants
|
69.1 years
STANDARD_DEVIATION 8.69 • n=7 Participants
|
69.7 years
STANDARD_DEVIATION 8.78 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
150 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
308 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
165 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
332 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
173 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
350 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Number of AK lesions at baseline
|
5.8 lesions
STANDARD_DEVIATION 1.20 • n=5 Participants
|
6.0 lesions
STANDARD_DEVIATION 1.27 • n=7 Participants
|
5.9 lesions
STANDARD_DEVIATION 1.24 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 57Population: ITT population included all randomized participants.
Complete clearance rate was defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area.
Outcome measures
| Measure |
Placebo
n=173 Participants
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
KX2-391 Ointment 1%
n=178 Participants
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
|---|---|---|
|
Percentage of Participants With Complete (100%) Clearance of Actinic Keratosis (AK) Lesions
|
13 percentage of participants
|
54 percentage of participants
|
SECONDARY outcome
Timeframe: Day 57Population: ITT population included all randomized participants.
Partial clearance rate of AK lesions was defined as the percentage of participants with a greater than or equal to (\>=) 75% reduction in the number of AK lesions identified at Baseline (Day 1 predose) in the treatment area.
Outcome measures
| Measure |
Placebo
n=173 Participants
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
KX2-391 Ointment 1%
n=178 Participants
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
|---|---|---|
|
Percentage of Participants With Partial Clearance Rate of Actinic Keratosis Lesions at Day 57
|
20 percentage of participants
|
76 percentage of participants
|
SECONDARY outcome
Timeframe: Days 8, 15, 29 and 57Population: ITT population included all randomized participants.
Overall the change from baseline in lesion count at each visit were summarized and reported using descriptive statistics by treatment location (face or scalp).
Outcome measures
| Measure |
Placebo
n=173 Participants
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
KX2-391 Ointment 1%
n=178 Participants
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
|---|---|---|
|
Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57
Day 15
|
-1.0 lesion count
Interval -7.0 to 1.0
|
-4.0 lesion count
Interval -8.0 to 3.0
|
|
Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57
Day 8
|
0.0 lesion count
Interval -8.0 to 1.0
|
-1.0 lesion count
Interval -7.0 to 3.0
|
|
Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57
Day 29
|
-1.0 lesion count
Interval -7.0 to 2.0
|
-5.0 lesion count
Interval -8.0 to 1.0
|
|
Overall Change From Baseline in Actinic Keratosis Lesion Counts at Days 8, 15, 29 and 57
Day 57
|
-1.0 lesion count
Interval -8.0 to 2.0
|
-5.0 lesion count
Interval -8.0 to 1.0
|
SECONDARY outcome
Timeframe: 3, 6, 9 and 12 months post-Day 57Population: Recurrence follow-up population included all participants in the ITT Population who achieved complete clearance at the Day 57 visit. The recurrence rate was evaluated only for KX2-391 Ointment 1% arm, pre-specified in protocol.
Recurrence rate was estimated based on Kaplan-Meier method, with recurrence define as appearance of any AK lesions in the treatment area, including those recurred or newly identified.
Outcome measures
| Measure |
Placebo
n=96 Participants
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
KX2-391 Ointment 1%
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
|---|---|---|
|
Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57
3 months post-Day 57
|
27 percentage of participants
|
—
|
|
Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57
6 months post-Day 57
|
31 percentage of participants
|
—
|
|
Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57
9 months post-Day 57
|
27 percentage of participants
|
—
|
|
Percentage of Participants With Recurrence of Actinic Keratosis Lesions Who Achieved Complete Clearance at Day 57
12 months post-Day 57
|
23 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 57Population: Safety analysis set included participants who received at least one dose of study treatment.
Maximal post baseline LSR was defined as the highest grade of any LSR reported at any post baseline visits for a participant. The LSR assessment was an Investigator's (or sub-investigator's) assessment of the following signs on the treatment area: erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. The LSRs were graded on a 4-point scale ranging from 0=absent, 1=mild (slightly, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense).
Outcome measures
| Measure |
Placebo
n=173 Participants
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
KX2-391 Ointment 1%
n=178 Participants
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
|---|---|---|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Erythema-Grade 0
|
79 Participants
|
3 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Erythema-Grade 1
|
81 Participants
|
47 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Erythema-Grade 2
|
13 Participants
|
111 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Erythema-Grade 3
|
0 Participants
|
17 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Flaking/Scaling-Grade 0
|
82 Participants
|
8 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Flaking/Scaling-Grade 1
|
69 Participants
|
60 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Flaking/Scaling-Grade 2
|
21 Participants
|
90 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Flaking/Scaling-Grade 3
|
1 Participants
|
20 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Crusting-Grade 0
|
148 Participants
|
92 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Crusting-Grade 1
|
19 Participants
|
51 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Crusting-Grade 2
|
6 Participants
|
30 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Crusting-Grade 3
|
0 Participants
|
5 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Swelling-Grade 0
|
169 Participants
|
110 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Swelling-Grade 1
|
4 Participants
|
47 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Swelling-Grade 2
|
0 Participants
|
20 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Swelling-Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Vesiculation/Pustulation-Grade 0
|
172 Participants
|
166 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Vesiculation/Pustulation-Grade 1
|
1 Participants
|
11 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Vesiculation/Pustulation-Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Vesiculation/Pustulation-Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Erosion/Ulceration-Grade 0
|
171 Participants
|
156 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Erosion/Ulceration-Grade 1
|
2 Participants
|
18 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Erosion/Ulceration-Grade 2
|
0 Participants
|
4 Participants
|
|
Number of Participants With Maximal Post Baseline Local Skin Reaction (LSR)
Erosion/Ulceration-Grade 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57Population: Safety Population included all randomized participants who received at least one dose of study treatment.
Absence or presence of pigmentation (i.e., hypopigmentation and hyperpigmentation) and scarring in the treatment area were assessed.
Outcome measures
| Measure |
Placebo
n=173 Participants
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
KX2-391 Ointment 1%
n=178 Participants
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
|---|---|---|
|
Number of Participants With Pigmentation and Scarring in the Treatment Area
Hypopigmentation: Day 8
|
23 Participants
|
30 Participants
|
|
Number of Participants With Pigmentation and Scarring in the Treatment Area
Hypopigmentation: Day 15
|
21 Participants
|
31 Participants
|
|
Number of Participants With Pigmentation and Scarring in the Treatment Area
Hypopigmentation: Day 29
|
21 Participants
|
32 Participants
|
|
Number of Participants With Pigmentation and Scarring in the Treatment Area
Hypopigmentation: Day 57
|
21 Participants
|
29 Participants
|
|
Number of Participants With Pigmentation and Scarring in the Treatment Area
Hyperpigmentation: Baseline
|
33 Participants
|
36 Participants
|
|
Number of Participants With Pigmentation and Scarring in the Treatment Area
Hyperpigmentation: Day 5
|
30 Participants
|
33 Participants
|
|
Number of Participants With Pigmentation and Scarring in the Treatment Area
Hyperpigmentation: Day 8
|
30 Participants
|
34 Participants
|
|
Number of Participants With Pigmentation and Scarring in the Treatment Area
Hyperpigmentation: Day 15
|
27 Participants
|
32 Participants
|
|
Number of Participants With Pigmentation and Scarring in the Treatment Area
Hyperpigmentation: Day 29
|
24 Participants
|
29 Participants
|
|
Number of Participants With Pigmentation and Scarring in the Treatment Area
Hyperpigmentation: Day 57
|
25 Participants
|
25 Participants
|
|
Number of Participants With Pigmentation and Scarring in the Treatment Area
Scarring: Baseline
|
9 Participants
|
11 Participants
|
|
Number of Participants With Pigmentation and Scarring in the Treatment Area
Scarring: Day 5
|
8 Participants
|
13 Participants
|
|
Number of Participants With Pigmentation and Scarring in the Treatment Area
Scarring: Day 8
|
8 Participants
|
11 Participants
|
|
Number of Participants With Pigmentation and Scarring in the Treatment Area
Scarring: Day 15
|
9 Participants
|
9 Participants
|
|
Number of Participants With Pigmentation and Scarring in the Treatment Area
Scarring: Day 29
|
8 Participants
|
9 Participants
|
|
Number of Participants With Pigmentation and Scarring in the Treatment Area
Scarring: Day 57
|
10 Participants
|
9 Participants
|
|
Number of Participants With Pigmentation and Scarring in the Treatment Area
Hypopigmentation: Baseline
|
26 Participants
|
30 Participants
|
|
Number of Participants With Pigmentation and Scarring in the Treatment Area
Hypopigmentation: Day 5
|
26 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1 predose) up to Day 57Population: Safety Population included all randomized participants who received at least one dose of study treatment.
An AE was defined as any untoward medical occurrence in participant which does not necessarily have causal relationship with treatment. An AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal product, whether or not considered related to medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death; was life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in patient hospitalization; was congenital anomaly/birth defect or otherwise considered medically important. TEAEs (serious and non-serious) were defined as either those AEs with onset after first dose or those pre-existing AEs that worsen after first dose. Events of special interest included skin cancers (including basal cell carcinoma, squamous cell carcinoma, melanoma and their location and treatment area), ocular exposure, overdose, and pregnancy.
Outcome measures
| Measure |
Placebo
n=173 Participants
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
KX2-391 Ointment 1%
n=178 Participants
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
|---|---|---|
|
Number of Participants With Adverse Event (AE), Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Events of Special Interests
Participants with AE
|
73 Participants
|
71 Participants
|
|
Number of Participants With Adverse Event (AE), Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Events of Special Interests
Participants with any TEAE
|
67 Participants
|
67 Participants
|
|
Number of Participants With Adverse Event (AE), Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Events of Special Interests
Participants with any SAE
|
4 Participants
|
1 Participants
|
|
Number of Participants With Adverse Event (AE), Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Events of Special Interests
Participants with events of special interest
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From Day 57 up to 12-months post-Day 57Population: Recurrence follow-up population included all participants in the ITT Population who achieved complete clearance at the Day 57 visit.
An AE was defined as any untoward medical occurrence in participant which does not necessarily have causal relationship with treatment. An AE was any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal product, whether or not considered related to medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death; was life threatening; required persistent/significant disability/incapacity; resulted in initial or prolonged in patient hospitalization; was congenital anomaly/birth defect or otherwise considered medically important. Events of special interest included skin cancers (including basal cell carcinoma, squamous cell carcinoma, melanoma and their location and treatment area), ocular exposure, overdose, and pregnancy.
Outcome measures
| Measure |
Placebo
n=22 Participants
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
KX2-391 Ointment 1%
n=97 Participants
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
|---|---|---|
|
Number of Participants With Adverse Events, Serious Adverse Events, Events of Special Interests Within the Treatment Area After Day 57 and up to 12 Months Post-Day 57
Participants with any AE
|
0 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events, Events of Special Interests Within the Treatment Area After Day 57 and up to 12 Months Post-Day 57
Participants with any SAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events, Events of Special Interests Within the Treatment Area After Day 57 and up to 12 Months Post-Day 57
Participants with events of special interest
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1 predose) up to Day 57Population: Safety Population included all randomized participants who received at least one dose of study treatment.
Assessed laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance and abnormal observations were determined by the investigator.
Outcome measures
| Measure |
Placebo
n=173 Participants
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
KX2-391 Ointment 1%
n=178 Participants
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
|---|---|---|
|
Number of Participants With Clinically Significant Safety Observations- Hematology, Blood Chemistry, Urinalysis
Hematology
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Safety Observations- Hematology, Blood Chemistry, Urinalysis
Blood chemistry
|
4 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Safety Observations- Hematology, Blood Chemistry, Urinalysis
Urinalysis
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1 predose) up to Day 57Population: Safety Population included all randomized participants who received at least one dose of study treatment.
Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Placebo
n=173 Participants
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
KX2-391 Ointment 1%
n=178 Participants
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
|---|---|---|
|
Number of Participants With Clinically Significant Safety Observations- Vital Signs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1 predose) up to Day 57Population: Safety Population included all randomized participants who received at least one dose of study treatment.
A physical examination included weight and height measurements was performed. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Placebo
n=173 Participants
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
KX2-391 Ointment 1%
n=178 Participants
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
|---|---|---|
|
Number of Participants With Clinically Significant Safety Observations- Physical Examination
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1 predose) up to Day 57Population: Safety Population included all randomized participants who received at least one dose of study treatment.
ECG parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Placebo
n=173 Participants
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
KX2-391 Ointment 1%
n=178 Participants
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
|---|---|---|
|
Number of Participants With Clinically Significant Safety Observations- Electrocardiograms (ECGs)
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 72 other events
Deaths: 0 deaths
KX2-391 Ointment 1%
Serious events: 1 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=173 participants at risk
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
KX2-391 Ointment 1%
n=178 participants at risk
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Chest pain
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Placebo
n=173 participants at risk
Vehicle Ointment was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
KX2-391 Ointment 1%
n=178 participants at risk
KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days in a treatment area of 25 cm\^2 on face or scalp.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Eye disorders
Diplopia
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Application site pruritus
|
7.5%
13/173 • Number of events 13 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
10.7%
19/178 • Number of events 19 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Application site pain
|
2.9%
5/173 • Number of events 5 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
13.5%
24/178 • Number of events 31 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Application site inflammation
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Application site nodule
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Application site paraesthesia
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Application site scab
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Chest discomfort
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Influenza like illness
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Nodule
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Peripheral swelling
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
10/173 • Number of events 10 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
4.5%
8/178 • Number of events 8 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.3%
4/173 • Number of events 4 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
5.1%
9/178 • Number of events 9 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
1.1%
2/178 • Number of events 2 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
1.7%
3/173 • Number of events 3 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
3/173 • Number of events 3 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
1.2%
2/173 • Number of events 2 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Application site folliculitis
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Carbuncle
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Herpes simplex
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Labyrinthitis
|
1.2%
2/173 • Number of events 2 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Localised infection
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pyuria
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Streptococcal infection
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Subcutaneous abscess
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.7%
3/173 • Number of events 4 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
2.2%
4/178 • Number of events 4 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
2/173 • Number of events 2 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 2 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
2/173 • Number of events 2 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Blood testosterone decreased
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Cardiac murmur
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Crystal urine present
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Prostatic specific antigen increased
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Urobilinogen urine increased
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Haemochromatosis
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
1.1%
2/178 • Number of events 2 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
1.1%
2/178 • Number of events 2 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
2.3%
4/173 • Number of events 5 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
1.7%
3/178 • Number of events 3 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.7%
3/173 • Number of events 3 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
1.7%
3/178 • Number of events 4 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer recurrent
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
|
1.7%
3/173 • Number of events 3 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
1.2%
2/173 • Number of events 2 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Nervous system disorder
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Ketonuria
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
3/173 • Number of events 3 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
2/173 • Number of events 2 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
1.1%
2/178 • Number of events 5 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
1.1%
2/178 • Number of events 2 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Lentigo
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Arthrodesis
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/173 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.56%
1/178 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
|
Surgical and medical procedures
Meniscus operation
|
0.58%
1/173 • Number of events 1 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
0.00%
0/178 • From Baseline (Day 1 predose) up to 15 months (12 months post-Day 57)
Safety population included all randomized participants who received at least one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place