Trial Outcomes & Findings for Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis (NCT NCT02100813)

NCT ID: NCT02100813

Last Updated: 2025-03-06

Results Overview

The number participants experiencing a DLT was used to identify the maximum tolerated dose (MTD) of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level with less than 4 out of 12 participants experiencing a DLT. A DLT was defined as: * Erosion/ulceration Grade 4 on the Local Skin Response (LSR) scale * Other clinically relevant signs or symptoms observed, which the International Co-ordinating Investigator judges to be counted as a DLT. The Local Skin Responses consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category are given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 220 participants
• Primary outcome timeframe: From Day 1 up to and including Day 8
• Results posted on: 2025-03-06

Participant Flow

Participants were recruited in 7 centres in the US into Part 1 of the trial. First participant was enrolled on 14-05-14 and the last subject´s last visit (LSLV) was on 12-08-14. Participants were recruited in 11 centres in the US and 5 centres in Germany into Part 2 of trial. First participant was enrolled on 03-09-14 and LSLV was on 02-03-14.

Participant milestones

Measure	Part 1 - 0.018% Cohort Part 1 - Dose escalation Once daily application with LEO 43204 gel (ingenol disoxate) 0.018% for two consecutive days on balding scalp.	Part 1 - 0.025% Cohort Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.025% for two consecutive days on balding scalp.	Part 1 - 0.037% Cohort Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.036% for two consecutive days on balding scalp.	Part 1 - 0.05% Cohort Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp.	Part 1 - 0.075% Cohort Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.075% for two consecutive days on balding scalp.	Part 2 - Vehicle Part 2 - Dose finding Once daily application with LEO 43204 gel vehicle for two consecutive days on balding scalp.	Part 2 - 0.037% Part 2 - Dose finding Once daily application with LEO 43204 gel 0.037% for two consecutive days on balding scalp.	Part 2 - 0.05% Part 2 - Dose finding Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp.
Overall Study STARTED	10	11	12	12	12	32	64	67
Overall Study COMPLETED	10	11	12	12	12	32	64	66
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	1

Reasons for withdrawal

Measure	Part 1 - 0.018% Cohort Part 1 - Dose escalation Once daily application with LEO 43204 gel (ingenol disoxate) 0.018% for two consecutive days on balding scalp.	Part 1 - 0.025% Cohort Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.025% for two consecutive days on balding scalp.	Part 1 - 0.037% Cohort Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.036% for two consecutive days on balding scalp.	Part 1 - 0.05% Cohort Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp.	Part 1 - 0.075% Cohort Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.075% for two consecutive days on balding scalp.	Part 2 - Vehicle Part 2 - Dose finding Once daily application with LEO 43204 gel vehicle for two consecutive days on balding scalp.	Part 2 - 0.037% Part 2 - Dose finding Once daily application with LEO 43204 gel 0.037% for two consecutive days on balding scalp.	Part 2 - 0.05% Part 2 - Dose finding Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp.
Overall Study Adverse Event	0	0	0	0	0	0	0	1

Baseline Characteristics

Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis

Baseline characteristics by cohort

Measure	Part 1 - 0.018% Cohort n=10 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.018% for two consecutive days on balding scalp.	Part 1 - 0.025% Cohort n=11 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.025% for two consecutive days on balding scalp.	Part 1 - 0.037% Cohort n=12 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.037% for two consecutive days on balding scalp.	Part 1 - 0.05% Cohort n=12 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp.	Part 1 - 0.075% Cohort n=12 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.075% for two consecutive days on balding scalp.	Part 2 - Vehicle n=32 Participants Part 2 - Dose finding Once daily application with LEO 43204 gel vehicle for two consecutive days on balding scalp.	Part 2 - 0.037% n=64 Participants Part 2 - Dose finding Once daily application with LEO 43204 gel 0.037% for two consecutive days on balding scalp.	Part 2 - 0.05% n=67 Participants Part 2 - Dose finding Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp.	Total n=220 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	9 Participants n=8 Participants	9 Participants n=8 Participants	14 Participants n=24 Participants	47 Participants n=42 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	10 Participants n=21 Participants	23 Participants n=8 Participants	55 Participants n=8 Participants	53 Participants n=24 Participants	173 Participants n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	12 Participants n=4 Participants	12 Participants n=21 Participants	32 Participants n=8 Participants	64 Participants n=8 Participants	67 Participants n=24 Participants	220 Participants n=42 Participants
Region of Enrollment United States	10 participants n=5 Participants	11 participants n=7 Participants	12 participants n=5 Participants	12 participants n=4 Participants	12 participants n=21 Participants	24 participants n=8 Participants	49 participants n=8 Participants	51 participants n=24 Participants	181 participants n=42 Participants
Region of Enrollment Germany	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	8 participants n=8 Participants	15 participants n=8 Participants	16 participants n=24 Participants	39 participants n=42 Participants

PRIMARY outcome

Timeframe: From Day 1 up to and including Day 8

The number participants experiencing a DLT was used to identify the maximum tolerated dose (MTD) of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level with less than 4 out of 12 participants experiencing a DLT.

A DLT was defined as:

• Erosion/ulceration Grade 4 on the Local Skin Response (LSR) scale
• Other clinically relevant signs or symptoms observed, which the International Co-ordinating Investigator judges to be counted as a DLT.

The Local Skin Responses consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category are given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity.

Outcome measures

Measure	Part 1 - 0.018% Cohort n=10 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.018% for two consecutive days on balding scalp.	Part 1 - 0.025% Cohort n=11 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.025% for two consecutive days on balding scalp.	Part 1 - 0.037% Cohort n=12 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.036% for two consecutive days on balding scalp.	Part 1 - 0.05% Cohort n=12 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp.	Part 1 - 0.075% Cohort n=12 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.075% for two consecutive days on balding scalp.
Part 1: Number of Participants Experiencing a Dose-limiting Toxicity (DLT) Yes	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants Experiencing a Dose-limiting Toxicity (DLT) No	10 Participants	11 Participants	12 Participants	12 Participants	12 Participants

PRIMARY outcome

Timeframe: From baseline to Week 8

Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) in the selected treatment area.

Outcome measures

Measure	Part 1 - 0.018% Cohort n=32 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.018% for two consecutive days on balding scalp.	Part 1 - 0.025% Cohort n=64 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.025% for two consecutive days on balding scalp.	Part 1 - 0.037% Cohort n=67 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.036% for two consecutive days on balding scalp.	Part 1 - 0.05% Cohort Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp.	Part 1 - 0.075% Cohort Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.075% for two consecutive days on balding scalp.
Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Lesion Count	12.6 percentage of reduction Interval -9.5 to 30.3	72.7 percentage of reduction Interval 66.9 to 77.5	78.5 percentage of reduction Interval 73.7 to 82.5	—	—

SECONDARY outcome

Timeframe: From baseline to Week 8

Complete clearance of AKs at Week 8 was defined as a 100% reduction from baseline in AK count.

Outcome measures

Measure	Part 1 - 0.018% Cohort n=32 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.018% for two consecutive days on balding scalp.	Part 1 - 0.025% Cohort n=64 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.025% for two consecutive days on balding scalp.	Part 1 - 0.037% Cohort n=67 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.036% for two consecutive days on balding scalp.	Part 1 - 0.05% Cohort Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp.	Part 1 - 0.075% Cohort Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.075% for two consecutive days on balding scalp.
Part 2: Participants With Complete Clearance of AKs	3.1 percentage of participants Interval 0.1 to 16.2	21.9 percentage of participants Interval 12.5 to 34.0	29.9 percentage of participants Interval 19.3 to 42.3	—	—

SECONDARY outcome

Timeframe: From baseline to Week 8

Partial clearance of AKs at Week 8 was defined as at least 75% reduction from baseline in AK count.

Outcome measures

Measure	Part 1 - 0.018% Cohort n=32 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.018% for two consecutive days on balding scalp.	Part 1 - 0.025% Cohort n=64 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.025% for two consecutive days on balding scalp.	Part 1 - 0.037% Cohort n=67 Participants Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.036% for two consecutive days on balding scalp.	Part 1 - 0.05% Cohort Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp.	Part 1 - 0.075% Cohort Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.075% for two consecutive days on balding scalp.
Part 2: Participants With Partial Clearance of AKs	6.3 percentage of participants Interval 0.8 to 20.8	54.7 percentage of participants Interval 41.7 to 67.2	59.7 percentage of participants Interval 47.0 to 71.5	—	—

Adverse Events

Part 1 - 0.018% Cohort

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part 1 - 0.025% Cohort

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part 1 - 0.037% Cohort

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Part 1 - 0.05% Cohort

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Part 1 - 0.075% Cohort

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Part 2 - Vehicle

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 2 - 0.037%

Serious events: 2 serious events

Other events: 47 other events

Deaths: 0 deaths

Part 2 - 0.05%

Serious events: 3 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1 - 0.018% Cohort n=10 participants at risk Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.018% for two consecutive days on balding scalp.	Part 1 - 0.025% Cohort n=11 participants at risk Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.025%for two consecutive days on balding scalp.	Part 1 - 0.037% Cohort n=12 participants at risk Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.036% for two consecutive days on balding scalp.	Part 1 - 0.05% Cohort n=12 participants at risk Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp.	Part 1 - 0.075% Cohort n=12 participants at risk Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.075% for two consecutive days on balding scalp.	Part 2 - Vehicle n=32 participants at risk Part 2 - Dose finding Once daily application with LEO 43204 gel vehicle for two consecutive days on balding scalp.	Part 2 - 0.037% n=64 participants at risk Part 2 - Dose finding Once daily application with LEO 43204 gel 0.037% for two consecutive days on balding scalp.	Part 2 - 0.05% n=67 participants at risk Part 2 - Dose finding Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Cardiac disorders Atrial flutter	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Nervous system disorders Convulsion	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Renal and urinary disorders Nephrolithiasis	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Cardiac disorders Acute myocardial infarction	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8

Other adverse events

Measure	Part 1 - 0.018% Cohort n=10 participants at risk Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.018% for two consecutive days on balding scalp.	Part 1 - 0.025% Cohort n=11 participants at risk Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.025%for two consecutive days on balding scalp.	Part 1 - 0.037% Cohort n=12 participants at risk Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.036% for two consecutive days on balding scalp.	Part 1 - 0.05% Cohort n=12 participants at risk Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp.	Part 1 - 0.075% Cohort n=12 participants at risk Part 1 - Dose escalation Once daily application with LEO 43204 gel 0.075% for two consecutive days on balding scalp.	Part 2 - Vehicle n=32 participants at risk Part 2 - Dose finding Once daily application with LEO 43204 gel vehicle for two consecutive days on balding scalp.	Part 2 - 0.037% n=64 participants at risk Part 2 - Dose finding Once daily application with LEO 43204 gel 0.037% for two consecutive days on balding scalp.	Part 2 - 0.05% n=67 participants at risk Part 2 - Dose finding Once daily application with LEO 43204 gel 0.05% for two consecutive days on balding scalp.
General disorders Application site pruritus	30.0% 3/10 • Number of events 3 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	27.3% 3/11 • Number of events 3 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	58.3% 7/12 • Number of events 7 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	41.7% 5/12 • Number of events 5 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	75.0% 9/12 • Number of events 10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.1% 1/32 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	25.0% 16/64 • Number of events 18 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	26.9% 18/67 • Number of events 18 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Application site pain	20.0% 2/10 • Number of events 3 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	36.4% 4/11 • Number of events 5 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	100.0% 12/12 • Number of events 18 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	75.0% 9/12 • Number of events 16 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	100.0% 12/12 • Number of events 17 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	6.2% 2/32 • Number of events 2 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	48.4% 31/64 • Number of events 42 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	56.7% 38/67 • Number of events 51 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Application site paraesthesia	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Number of events 2 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.1% 1/32 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Application site discomfort	10.0% 1/10 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	4.5% 3/67 • Number of events 3 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Application site discharge	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Application site hyperaesthesia	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Application site oedema	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Injury, poisoning and procedural complications Accidental exposure	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Investigations Alanine aminotransferase increased	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Investigations Aspartate aminotransferase increased	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Chills	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.1% 2/64 • Number of events 2 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	6.0% 4/67 • Number of events 4 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.1% 2/64 • Number of events 2 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Asthenia	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Investigations Blood urine present	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.1% 1/32 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Psychiatric disorders Confusional state	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Eye disorders Conjunctivitis	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Skin and subcutaneous tissue disorders Circumoral oedema	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Surgical and medical procedures Cholecystectomy	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Ear and labyrinth disorders Ear pain	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Investigations Electrocardiogram abnormal	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Discomfort	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Investigations Electrocardiogram t wave abnormal	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Investigations Electrocardiogram u-wave abnormality	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Gastroenteritis	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	9.1% 1/11 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Fatigue	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Eye disorders Eyelid oedema	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Feeling abnormal	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Folliculitis	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.1% 1/32 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Gastroenteritis viral	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.1% 1/32 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Hordeolum	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	9.1% 1/11 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Herpes zoster	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Injury, poisoning and procedural complications Head injury	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Nervous system disorders Hyperaesthesia	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.0% 2/67 • Number of events 2 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Herpes simplex	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Nervous system disorders Headache	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	9.1% 1/11 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	16.7% 2/12 • Number of events 2 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	9.4% 6/64 • Number of events 7 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	7.5% 5/67 • Number of events 5 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Psychiatric disorders Insomnia	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	33.3% 4/12 • Number of events 4 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Influenza	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Injury, poisoning and procedural complications Injury	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Vascular disorders Hypertension	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Eye disorders Lacrimation increased	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Number of events 2 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Injury, poisoning and procedural complications Laceration	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Nasopharyngitis	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.1% 1/32 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.1% 2/64 • Number of events 2 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	9.0% 6/67 • Number of events 6 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Respiratory, thoracic and mediastinal disorders Nasal oedema	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Eye disorders Periorbital oedema	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	9.1% 1/11 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	16.7% 2/12 • Number of events 2 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	4.7% 3/64 • Number of events 3 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	6.0% 4/67 • Number of events 5 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Oral herpes	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.1% 2/64 • Number of events 2 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Pain	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Onychomycosis	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Gastrointestinal disorders Nausea	10.0% 1/10 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	8.3% 1/12 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Injury, poisoning and procedural complications Procedural pain	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Skin and subcutaneous tissue disorders Scar	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Eye disorders Retinal detachment	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Vascular disorders Peripheral artery aneurysm	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Psychiatric disorders Sleep disorder	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	3.0% 2/67 • Number of events 2 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Nervous system disorders Tension headache	20.0% 2/10 • Number of events 2 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Gastrointestinal disorders Toothache	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Upper respiratory tract infection	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Gastrointestinal disorders Vomiting	10.0% 1/10 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Urinary tract infection	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Infections and infestations Visceral larva migrans	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.6% 1/64 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/67 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
Eye disorders Xerophthalmia	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8
General disorders Oedema peripheral	0.00% 0/10 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/11 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/12 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/32 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	0.00% 0/64 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8	1.5% 1/67 • Number of events 1 • Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8

Additional Information

Clinical Trial Disclosure Specialist

LEO Pharma A/S

Phone: +45 44945888

Email: disclosure@leo-pharma.com

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