Trial Outcomes & Findings for Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque Psoriasis (NCT NCT01235442)

Last Updated: 2018-08-07

Results Overview

The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

592 participants

Primary outcome timeframe

Week 12

Results posted on

2018-08-07

Participant Flow

Participants were enrolled from 15 September 2010 through 17 October 2011.

Participant milestones

Participant milestones
Measure	Etanercept Monotherapy Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).	Etanercept + Clobetasol Propionate Foam Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
Overall Study STARTED	297	295
Overall Study COMPLETED	253	251
Overall Study NOT COMPLETED	44	44

Reasons for withdrawal

Reasons for withdrawal
Measure	Etanercept Monotherapy Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).	Etanercept + Clobetasol Propionate Foam Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
Overall Study Lost to Follow-up	12	10
Overall Study Death	0	2
Overall Study Pregnancy	1	1
Overall Study Ineligibility determined	5	4
Overall Study Protocol Violation	3	3
Overall Study Adverse Event	4	6
Overall Study Withdrawal by Subject	15	9
Overall Study Lack of Efficacy	1	3
Overall Study Noncompliance	1	2
Overall Study Administrative decision	1	2
Overall Study Other unspecified	1	2

Baseline Characteristics

Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etanercept Monotherapy n=297 Participants Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).	Etanercept + Clobetasol Propionate Foam n=295 Participants Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).	Total n=592 Participants Total of all reporting groups
Age, Continuous	44.6 Years STANDARD_DEVIATION 13.7 • n=5 Participants	43.7 Years STANDARD_DEVIATION 14.2 • n=7 Participants	44.1 Years STANDARD_DEVIATION 13.9 • n=5 Participants
Age, Customized < 65 years	273 Participants n=5 Participants	273 Participants n=7 Participants	546 Participants n=5 Participants
Age, Customized >=65 years	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Female	101 Participants n=5 Participants	100 Participants n=7 Participants	201 Participants n=5 Participants
Sex: Female, Male Male	196 Participants n=5 Participants	195 Participants n=7 Participants	391 Participants n=5 Participants
Race/Ethnicity, Customized White	254 Participants n=5 Participants	237 Participants n=7 Participants	491 Participants n=5 Participants
Race/Ethnicity, Customized Asian	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	13 Participants n=5 Participants	18 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific	0 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Mixed Race	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
BMI Categorical ≤ 35 kg/m^2	222 Participants n=5 Participants	221 Participants n=7 Participants	443 Participants n=5 Participants
BMI Categorical > 35 kg/m^2	75 Participants n=5 Participants	74 Participants n=7 Participants	149 Participants n=5 Participants
Psoriasis area severity index (PASI)	18.17 Scores on a scale STANDARD_DEVIATION 8.25 • n=5 Participants	18.85 Scores on a scale STANDARD_DEVIATION 9.16 • n=7 Participants	18.51 Scores on a scale STANDARD_DEVIATION 8.72 • n=5 Participants
Psoriasis Body Surface Area(BSA)	24.09 % STANDARD_DEVIATION 17.22 • n=5 Participants	25.93 % STANDARD_DEVIATION 17.65 • n=7 Participants	25.01 % STANDARD_DEVIATION 17.44 • n=5 Participants
Static physician global assessment of psoriasis (sPGA) 0	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Static physician global assessment of psoriasis (sPGA) 1	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Static physician global assessment of psoriasis (sPGA) 2	36 Participants n=5 Participants	46 Participants n=7 Participants	82 Participants n=5 Participants
Static physician global assessment of psoriasis (sPGA) 3	176 Participants n=5 Participants	164 Participants n=7 Participants	340 Participants n=5 Participants
Static physician global assessment of psoriasis (sPGA) 4	74 Participants n=5 Participants	74 Participants n=7 Participants	148 Participants n=5 Participants
Static physician global assessment of psoriasis (sPGA) 5	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Static physician global assessment of psoriasis (sPGA) Unknown	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Patient global assessment of psoriasis 0	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Patient global assessment of psoriasis 1	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Patient global assessment of psoriasis 2	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Patient global assessment of psoriasis 3	49 Participants n=5 Participants	58 Participants n=7 Participants	107 Participants n=5 Participants
Patient global assessment of psoriasis 4	117 Participants n=5 Participants	95 Participants n=7 Participants	212 Participants n=5 Participants
Patient global assessment of psoriasis 5	124 Participants n=5 Participants	127 Participants n=7 Participants	251 Participants n=5 Participants
Patient global assessment of psoriasis Unkown	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Dermatology life quality index (DLQI)	14.6 (MEAN) STANDARD_DEVIATION 6.9 • n=5 Participants	14.1 (MEAN) STANDARD_DEVIATION 7.4 • n=7 Participants	14.3 (MEAN) STANDARD_DEVIATION 7.1 • n=5 Participants
Patient assessment of treatment satisfaction Very dissatisfied	110 Participants n=5 Participants	103 Participants n=7 Participants	213 Participants n=5 Participants
Patient assessment of treatment satisfaction Dissatisfied	40 Participants n=5 Participants	47 Participants n=7 Participants	87 Participants n=5 Participants
Patient assessment of treatment satisfaction Neither satisfied nor dissatisfied	109 Participants n=5 Participants	100 Participants n=7 Participants	209 Participants n=5 Participants
Patient assessment of treatment satisfaction Satisfied	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Patient assessment of treatment satisfaction Very satisfied	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Patient assessment of treatment satisfaction Unknown	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Psoriatic arthritis Yes	84 Participants n=5 Participants	68 Participants n=7 Participants	152 Participants n=5 Participants
Psoriatic arthritis No	213 Participants n=5 Participants	227 Participants n=7 Participants	440 Participants n=5 Participants
Duration of psoriasis	17.68 Years STANDARD_DEVIATION 11.31 • n=5 Participants	17.39 Years STANDARD_DEVIATION 11.89 • n=7 Participants	17.53 Years STANDARD_DEVIATION 11.59 • n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Intention-to-Treat with last observation carried forward (LOCF) imputation

Outcome measures

Outcome measures
Measure	Etanercept Monotherapy n=297 Participants Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).	Etanercept + Clobetasol Propionate Foam n=295 Participants Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
PASI 75 at Week 12	48.3 Percentage of participants	65.2 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Intention-to-Treat with last observation carried forward (LOCF) imputation

The percentage of participants achieving sPGA 0 or 1 at week 12. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.

Outcome measures

Outcome measures
Measure	Etanercept Monotherapy n=297 Participants Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).	Etanercept + Clobetasol Propionate Foam n=295 Participants Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
sPGA (0,1) at Week 12	47.3 Percentage of participants	63.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Intention-to-Treat with last observation carried forward (LOCF) imputation

The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 90 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 90% reduction in the PASI score from Baseline.

Outcome measures

Outcome measures
Measure	Etanercept Monotherapy n=297 Participants Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).	Etanercept + Clobetasol Propionate Foam n=295 Participants Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
PASI 90 at Week 12	19.4 Percentage of participants	29.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: PRO analysis set, including all subjects randomized and also complete the baseline and at least 1 of the post-baseline PRO assessment with last observation carried forward (LOCF) imputation

Patient assessment of treatment satisfaction status at week 12. It is a measure of a participant's level of satisfaction with the medication's control of psoriasis, ranging from "very satisfied" to "very dissatisfied."

Outcome measures

Outcome measures
Measure	Etanercept Monotherapy n=297 Participants Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).	Etanercept + Clobetasol Propionate Foam n=295 Participants Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
Patient Satisfaction at Week 12 Very satisfied	39.5 Percentage of participants	51.8 Percentage of participants
Patient Satisfaction at Week 12 Very dissatisfied	2.8 Percentage of participants	3.9 Percentage of participants
Patient Satisfaction at Week 12 Dissatisfied	4.9 Percentage of participants	4.3 Percentage of participants
Patient Satisfaction at Week 12 Neither satisfied nor dissatisfied	14.7 Percentage of participants	5.3 Percentage of participants
Patient Satisfaction at Week 12 Satisfied	38.1 Percentage of participants	34.8 Percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Intention-to-Treat with last observation carried forward (LOCF) imputation

The percentage of the improvement in PASI score at week 12 from baseline. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity.

Outcome measures

Outcome measures
Measure	Etanercept Monotherapy n=297 Participants Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).	Etanercept + Clobetasol Propionate Foam n=295 Participants Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
Percent PASI Improvement From Baseline at Week 12	68.18 Percentage of Improvement in PASI score Standard Deviation 29.31	76.46 Percentage of Improvement in PASI score Standard Deviation 24.01

SECONDARY outcome

Timeframe: Week 24

Population: Intention-to-Treat with last observation carried forward (LOCF) imputation

The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 24. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.

Outcome measures

Outcome measures
Measure	Etanercept Monotherapy n=297 Participants Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).	Etanercept + Clobetasol Propionate Foam n=295 Participants Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
PASI 75 at Week 24	63.6 Percentage of participants	69.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Intention-to-Treat with last observation carried forward (LOCF) imputation

The percentage of participants achieving sPGA 0 or 1 at week 24. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.

Outcome measures

Outcome measures
Measure	Etanercept Monotherapy n=297 Participants Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).	Etanercept + Clobetasol Propionate Foam n=295 Participants Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
sPGA (0,1) at Week 24	54.8 Percentage of participants	61.7 Percentage of participants

Adverse Events

Etanercept Monotherapy

Serious events: 6 serious events

Other events: 81 other events

Deaths: 0 deaths

Etanercept + Clobetasol Propionate Foam

Serious events: 7 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Etanercept Monotherapy n=301 participants at risk Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).	Etanercept + Clobetasol Propionate Foam n=288 participants at risk Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
Infections and infestations Nasopharyngitis	8.6% 26/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	8.3% 24/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
Infections and infestations Sinusitis	4.7% 14/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	6.2% 18/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
Infections and infestations Upper respiratory tract infection	11.6% 35/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	6.9% 20/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
Nervous system disorders Headache	7.3% 22/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	5.2% 15/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	Etanercept Monotherapy n=301 participants at risk Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).	Etanercept + Clobetasol Propionate Foam n=288 participants at risk Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
Cardiac disorders Cardio-respiratory arrest	0.00% 0/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	0.35% 1/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
General disorders Death	0.00% 0/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	0.35% 1/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
General disorders Pyrexia	0.33% 1/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	0.00% 0/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
Infections and infestations Cellulitis	0.33% 1/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	0.00% 0/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
Infections and infestations Endometritis	0.00% 0/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	0.35% 1/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
Infections and infestations Pneumonia	0.00% 0/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	0.35% 1/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
Infections and infestations Tubo-ovarian abscess	0.00% 0/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	0.35% 1/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	0.35% 1/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
Injury, poisoning and procedural complications Hip fracture	0.33% 1/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	0.00% 0/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
Injury, poisoning and procedural complications Overdose	0.33% 1/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	0.00% 0/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	0.35% 1/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	0.35% 1/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	0.35% 1/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
Nervous system disorders Syncope	0.33% 1/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	0.00% 0/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.33% 1/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	0.00% 0/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
Vascular disorders Hypertension	0.33% 1/301 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.	0.00% 0/288 • 28 weeks The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm. The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.