Trial Outcomes & Findings for A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas (NCT NCT01815840)

Last Updated: 2017-09-28

Results Overview

The total number of clinically evident basal cell carcinomas = the total number of target and/or non-target lesions present in individual participants.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

229 participants

Primary outcome timeframe

Baseline; Week 73

Results posted on

2017-09-28

Participant Flow

229 participants were enrolled in 10 countries.

Participant milestones

Participant milestones
Measure	Vismodegib Intermittent Schedule Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Vismodegib Induction Followed by Intermittent Schedule Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Overall Study STARTED	116	113
Overall Study COMPLETED	57	50
Overall Study NOT COMPLETED	59	63

Reasons for withdrawal

Reasons for withdrawal
Measure	Vismodegib Intermittent Schedule Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Vismodegib Induction Followed by Intermittent Schedule Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Overall Study Missing	1	0
Overall Study Withdrew Consent	31	30
Overall Study Administrative/Other	1	3
Overall Study Adverse Event	10	16
Overall Study Death	2	2
Overall Study Disease progression	3	2
Overall Study Investigators Decision	2	3
Overall Study Lost to Follow-up	3	6
Overall Study Refused Treatment	5	1
Overall Study Sponsor Termination Treatment	1	0

Baseline Characteristics

A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vismodegib Intermittent Schedule n=116 Participants Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Vismodegib Induction Followed by Intermittent Schedule n=113 Participants Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Total n=229 Participants Total of all reporting groups
Age, Continuous	61.1 years STANDARD_DEVIATION 13.94 • n=5 Participants	59.9 years STANDARD_DEVIATION 15.35 • n=7 Participants	60.5 years STANDARD_DEVIATION 14.63 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	25 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	81 Participants n=5 Participants	88 Participants n=7 Participants	169 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline; Week 73

Population: Participants in the Intent-to-Treat analysis population (defined as all randomized participants) with available data were included in the analysis. The last observation carried forward method was used.

The total number of clinically evident basal cell carcinomas = the total number of target and/or non-target lesions present in individual participants.

Outcome measures

Outcome measures
Measure	Vismodegib Intermittent Schedule n=114 Participants Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Vismodegib Induction Followed by Intermittent Schedule n=113 Participants Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Mean Percent Change From Baseline in the Number of Clinically Evident Basal Cell Carcinomas at Week 73 (After 72 Weeks of Treatment)	62.9 percent change Standard Deviation 52.01	54.9 percent change Standard Deviation 54.85

SECONDARY outcome

Timeframe: Baseline to Week 73

Population: Intent-to-Treat Analysis Population, defined as all randomized participants.

The percentage of participants who discontinued study treatment (due either to adverse event, refusal of treatment, or withdrawal of consent) was summarized by treatment group.

Outcome measures

Outcome measures
Measure	Vismodegib Intermittent Schedule n=116 Participants Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Vismodegib Induction Followed by Intermittent Schedule n=113 Participants Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues Overall	37.1 percentage of participants Interval 28.3 to 46.5	41.6 percentage of participants Interval 32.4 to 51.2
Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues Adverse Events	20.7 percentage of participants Interval 13.7 to 29.2	27.4 percentage of participants Interval 19.5 to 36.6
Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues Refused Treatment	6.0 percentage of participants Interval 2.5 to 12.0	2.7 percentage of participants Interval 0.6 to 7.6
Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues Withdrew Consent	10.3 percentage of participants Interval 5.5 to 17.4	11.5 percentage of participants Interval 6.3 to 18.9

SECONDARY outcome

Timeframe: Baseline; Week 73

Population: Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.

The three target basal cell carcinoma lesions = the three largest visible lesions, at least 5 mm in the longest diameter, in individual participants.

Outcome measures

Outcome measures
Measure	Vismodegib Intermittent Schedule n=94 Participants Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Vismodegib Induction Followed by Intermittent Schedule n=86 Participants Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Mean Percent Change From Baseline in Total Size of Three Target Basal Cell Carcinoma Lesions in Individual Participants at Week 73	82.9 percent change Standard Deviation 27.01	68.0 percent change Standard Deviation 53.02

SECONDARY outcome

Timeframe: Baseline; Week 73

Population: Intent-to-Treat Analysis Population, defined as all randomized participants.

Outcome measures

Outcome measures
Measure	Vismodegib Intermittent Schedule n=116 Participants Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Vismodegib Induction Followed by Intermittent Schedule n=113 Participants Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Percentage of Participants With at Least 50% Reduction in the Number of Basal Cell Carcinomas at Week 73	65.5 percentage of participants	50.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline; Week 73

Population: Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.

Outcome measures

Outcome measures
Measure	Vismodegib Intermittent Schedule n=94 Participants Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Vismodegib Induction Followed by Intermittent Schedule n=86 Participants Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Percentage of Participants With New Basal Cell Carcinomas at Week 73 No new lesions	76.6 percentage of participants	74.4 percentage of participants
Percentage of Participants With New Basal Cell Carcinomas at Week 73 1 new lesion	10.6 percentage of participants	11.6 percentage of participants
Percentage of Participants With New Basal Cell Carcinomas at Week 73 2 new lesions	5.3 percentage of participants	5.8 percentage of participants
Percentage of Participants With New Basal Cell Carcinomas at Week 73 3 new lesions	5.3 percentage of participants	2.3 percentage of participants
Percentage of Participants With New Basal Cell Carcinomas at Week 73 >3 new lesions	2.1 percentage of participants	5.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline; Week 85

Population: Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.

Outcome measures

Outcome measures
Measure	Vismodegib Intermittent Schedule n=90 Participants Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Vismodegib Induction Followed by Intermittent Schedule n=77 Participants Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 85 (12 Weeks Following End of Treatment) (Recurrence Rate)	35.7 percent change Standard Deviation 50.25	38.5 percent change Standard Deviation 55.22

SECONDARY outcome

Timeframe: Baseline; Week 97

Population: Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.

Outcome measures

Outcome measures
Measure	Vismodegib Intermittent Schedule n=84 Participants Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Vismodegib Induction Followed by Intermittent Schedule n=72 Participants Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 97 (24 Weeks Following End of Treatment) (Recurrence Rate)	36.0 percent change Standard Deviation 49.48	42.1 percent change Standard Deviation 57.83

SECONDARY outcome

Timeframe: Baseline; Week 125

Population: Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.

Outcome measures

Outcome measures
Measure	Vismodegib Intermittent Schedule n=95 Participants Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Vismodegib Induction Followed by Intermittent Schedule n=82 Participants Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 125 (52 Weeks Following End of Treatment) (Recurrence Rate)	41.2 percent change Standard Deviation 45.23	44.0 percent change Standard Deviation 42.87

SECONDARY outcome

Timeframe: Up to 125 weeks

Population: Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Vismodegib Intermittent Schedule n=114 Participants Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Vismodegib Induction Followed by Intermittent Schedule n=113 Participants Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Percentage of Participants Experiencing Any Adverse Event	99.1 percentage of participants	97.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline; Week 73

Population: Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.

The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their symptoms, and their answers were combined into a composite Symptom Domain Score. Scores range from 0 ("never bothered") to 100 ("always bothered").

Outcome measures

Outcome measures
Measure	Vismodegib Intermittent Schedule n=87 Participants Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Vismodegib Induction Followed by Intermittent Schedule n=79 Participants Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Percent Change From Baseline in the Skindex-16 Symptom Domain Score at Week 73	-14.9 percent change Standard Deviation 25.75	-12.6 percent change Standard Deviation 23.98

SECONDARY outcome

Timeframe: Baseline; Week 73

Population: Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.

The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their emotional state, and their answers were combined into a composite Emotion Domain Score. Scores range from 0 ("never bothered") to 100 ("always bothered").

Outcome measures

Outcome measures
Measure	Vismodegib Intermittent Schedule n=87 Participants Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Vismodegib Induction Followed by Intermittent Schedule n=79 Participants Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Percent Change From Baseline in the Skindex-16 Emotion Domain Score at Week 73	-27.4 percent change Standard Deviation 27.71	-28.9 percent change Standard Deviation 28.16

SECONDARY outcome

Timeframe: Baseline; Week 73

Population: Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.

The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their ability to function, and answers were combined into a composite Function Domain Score. Scores range from 0 ("never bothered") to 100 ("always bothered").

Outcome measures

Outcome measures
Measure	Vismodegib Intermittent Schedule n=87 Participants Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Vismodegib Induction Followed by Intermittent Schedule n=79 Participants Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Percent Change From Baseline in the Skindex-16 Function Domain Score at Week 73	-9.5 percent change Standard Deviation 20.59	-10.3 percent change Standard Deviation 26.03

Adverse Events

Vismodegib Intermittent Schedule

Serious events: 24 serious events

Other events: 107 other events

Deaths: 0 deaths

Vismodegib Induction Followed by Intermittent Schedule

Serious events: 23 serious events

Other events: 108 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Vismodegib Intermittent Schedule n=114 participants at risk Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up	Vismodegib Induction Followed by Intermittent Schedule n=113 participants at risk Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
Musculoskeletal and connective tissue disorders Muscle spasms	72.8% 83/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	83.2% 94/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	15.8% 18/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	14.2% 16/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	15.8% 18/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	10.6% 12/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	6.1% 7/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	6.2% 7/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Nervous system disorders Dysgeusia	66.7% 76/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	66.4% 75/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Nervous system disorders Ageusia	11.4% 13/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	12.4% 14/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Nervous system disorders Headache	8.8% 10/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	12.4% 14/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Alopecia	63.2% 72/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	64.6% 73/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	7.0% 8/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	11.5% 13/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Actinic keratosis	8.8% 10/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	7.1% 8/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	17.5% 20/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	17.7% 20/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	20.2% 23/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	12.4% 14/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain	7.0% 8/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	10.6% 12/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Gastrointestinal disorders Constipation	7.9% 9/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	7.1% 8/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain upper	7.9% 9/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	4.4% 5/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	6.1% 7/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	3.5% 4/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
General disorders Fatigue	21.1% 24/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	23.0% 26/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
General disorders Asthenia	13.2% 15/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	18.6% 21/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Investigations Weight decreased	21.1% 24/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	18.6% 21/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Investigations Blood creatine phosphokinase increased	9.6% 11/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	13.3% 15/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Investigations Alanine aminotransferase increased	6.1% 7/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	4.4% 5/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Infections and infestations Nasopharyngitis	6.1% 7/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	10.6% 12/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Infections and infestations Folliculitis	8.8% 10/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	7.1% 8/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Infections and infestations Bronchitis	4.4% 5/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	7.1% 8/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Infections and infestations Upper respiratory tract infection	6.1% 7/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	4.4% 5/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	18.4% 21/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	15.0% 17/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Eczema	5.3% 6/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	0.00% 0/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash	2.6% 3/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	6.2% 7/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	5.3% 6/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	1.8% 2/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Psychiatric disorders Insomnia	4.4% 5/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	5.3% 6/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 6/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	4.4% 5/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
Vascular disorders Hypertension	1.8% 2/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	5.3% 6/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.
General disorders Pyrexia	0.88% 1/114 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.	7.1% 8/113 • Up to 125 weeks Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.