Trial Outcomes & Findings for Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up (NCT NCT02549352)
NCT ID: NCT02549352
Last Updated: 2025-03-13
Results Overview
The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Weeks 4, and 8. Complete clearance was defined as no clinically visible AKs in the treatment area. The table shows the percentage of mean number of participants across imputations with complete clearance at Week 8.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
391 participants
Primary outcome timeframe
At Week 8
Results posted on
2025-03-13
Participant Flow
391 participants were enrolled, 80 were screening failures, and 311 participants were randomized. Only 310 of the randomized participants were treated with investigational medicinal product (IMP), the number of participants treated is reflected as the number of participants started in the first period.
Participant milestones
| Measure |
LEO 43204 0.037% Gel
Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.
|
Vehicle Gel
Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
|
|---|---|---|
|
3-day Treatment and 8-week Follow-up
STARTED
|
209
|
102
|
|
3-day Treatment and 8-week Follow-up
Treated
|
209
|
101
|
|
3-day Treatment and 8-week Follow-up
COMPLETED
|
207
|
96
|
|
3-day Treatment and 8-week Follow-up
NOT COMPLETED
|
2
|
6
|
|
12-month Follow-up
STARTED
|
207
|
93
|
|
12-month Follow-up
COMPLETED
|
199
|
81
|
|
12-month Follow-up
NOT COMPLETED
|
8
|
12
|
Reasons for withdrawal
| Measure |
LEO 43204 0.037% Gel
Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.
|
Vehicle Gel
Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
|
|---|---|---|
|
3-day Treatment and 8-week Follow-up
Adverse Event
|
0
|
1
|
|
3-day Treatment and 8-week Follow-up
Withdrawal by Subject
|
2
|
3
|
|
3-day Treatment and 8-week Follow-up
Other
|
0
|
2
|
|
12-month Follow-up
Withdrawal by Subject
|
4
|
5
|
|
12-month Follow-up
Lost to Follow-up
|
3
|
2
|
|
12-month Follow-up
Death
|
0
|
1
|
|
12-month Follow-up
Protocol Violation
|
0
|
1
|
|
12-month Follow-up
Other
|
1
|
3
|
Baseline Characteristics
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up
Baseline characteristics by cohort
| Measure |
LEO 43204 0.037% Gel
n=209 Participants
Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.
|
Vehicle Gel
n=101 Participants
Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
71.0 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
70.1 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Age, Customized
Age group · 18-64 years
|
60 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Age, Customized
Age group · 65-84 years
|
139 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Age, Customized
Age group · >=85 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
209 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
310 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
45 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
23 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
141 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 8The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Weeks 4, and 8. Complete clearance was defined as no clinically visible AKs in the treatment area. The table shows the percentage of mean number of participants across imputations with complete clearance at Week 8.
Outcome measures
| Measure |
LEO 43204 0.037% Gel
n=209 Participants
Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.
|
Vehicle Gel
n=101 Participants
Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
|
|---|---|---|
|
Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)
|
22.0 percentage of participants
Interval 16.4 to 27.7
|
3.0 percentage of participants
Interval -0.3 to 6.3
|
SECONDARY outcome
Timeframe: At Week 8The number of clinically visible Actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Weeks 4, and Week 8. Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area. The table shows the percentage of mean number of participants across imputations with partial clearance at Week 8.
Outcome measures
| Measure |
LEO 43204 0.037% Gel
n=209 Participants
Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.
|
Vehicle Gel
n=101 Participants
Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
|
|---|---|---|
|
Percentage of Participants With Partial Clearance
|
63.1 percentage of participants
Interval 56.5 to 69.7
|
11.0 percentage of participants
Interval 4.9 to 17.2
|
SECONDARY outcome
Timeframe: At Week 4The number of clinically visible Actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Weeks 4, and Week 8. Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area. The table shows the percentage of mean number of participants across imputations with partial clearance at Week 4.
Outcome measures
| Measure |
LEO 43204 0.037% Gel
n=209 Participants
Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.
|
Vehicle Gel
n=101 Participants
Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
|
|---|---|---|
|
Percentage of Participants With Partial Clearance
|
53.4 percentage of participants
Interval 46.5 to 60.3
|
7.1 percentage of participants
Interval 2.0 to 12.1
|
SECONDARY outcome
Timeframe: At Week 8The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable (using multiple imputations to account for missing values). The table presents adjusted mean percent reduction at Week 8 from baseline.
Outcome measures
| Measure |
LEO 43204 0.037% Gel
n=209 Participants
Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.
|
Vehicle Gel
n=101 Participants
Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
|
|---|---|---|
|
Percent Reduction in AK Count in the Treatment Area Compared to Baseline
|
74.0 percentage of change
Interval 70.6 to 77.1
|
13.7 percentage of change
Interval 0.2 to 25.3
|
Adverse Events
LEO 43204 0.037% Gel
Serious events: 3 serious events
Other events: 146 other events
Deaths: 0 deaths
Vehicle Gel
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
LEO 43204 0.037% Gel - Extended Follow-up
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Vehicle Gel - Extended Follow-up
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LEO 43204 0.037% Gel
n=210 participants at risk
Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.
|
Vehicle Gel
n=100 participants at risk
Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
|
LEO 43204 0.037% Gel - Extended Follow-up
n=208 participants at risk
Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.
|
Vehicle Gel - Extended Follow-up
n=92 participants at risk
Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.48%
1/210 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/208 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/92 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/210 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
1.0%
1/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/208 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/92 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.48%
1/210 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/208 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/92 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
|
Nervous system disorders
Syncope
|
0.00%
0/210 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
1.0%
1/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/208 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/92 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.48%
1/210 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/208 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/92 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/210 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
1.0%
1/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/208 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/92 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
Other adverse events
| Measure |
LEO 43204 0.037% Gel
n=210 participants at risk
Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.
|
Vehicle Gel
n=100 participants at risk
Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
|
LEO 43204 0.037% Gel - Extended Follow-up
n=208 participants at risk
Treatment once daily with LEO 43204 0.037% gel for 3 consecutive days applied on the scalp.
|
Vehicle Gel - Extended Follow-up
n=92 participants at risk
Treatment once daily with vehicle gel for 3 consecutive days applied on the scalp.
|
|---|---|---|---|---|
|
General disorders
Application site pain
|
56.2%
118/210 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
3.0%
3/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.48%
1/208 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/92 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
|
General disorders
Application site pruritus
|
32.4%
68/210 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
8.0%
8/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.48%
1/208 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/92 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
|
Eye disorders
Eyelid oedema
|
4.3%
9/210 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/208 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/92 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
|
Eye disorders
Periorbital oedema
|
4.3%
9/210 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/208 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/92 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
|
Eye disorders
Eye irritation
|
2.4%
5/210 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/208 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/92 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
|
Nervous system disorders
Headache
|
5.2%
11/210 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
1.0%
1/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/208 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/92 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
|
Psychiatric disorders
Insomnia
|
7.1%
15/210 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/208 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/92 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/210 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
0.00%
0/100 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
2.4%
5/208 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
1.1%
1/92 • Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)
Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review. For further details on the adjudication outcomes, see link to the full report in section "More information" Adverse events are reported with a \>=2% frequency threshold for the active treatment group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee LEO acknowledges the investigators right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
- Publication restrictions are in place
Restriction type: OTHER