Trial Outcomes & Findings for Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents (NCT NCT02276612)

NCT ID: NCT02276612

Last Updated: 2018-11-19

Results Overview

The percentage of participants experiencing any treatment-emergent serious adverse event was summarized.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

60 participants

Primary outcome timeframe

Up to Week 48

Results posted on

2018-11-19

Participant Flow

Participants were enrolled at study sites in South Africa and the United States. The first participant was screened on 03 December 2014. The last study visit occurred on 23 October 2017.

68 participants were screened.

Participant milestones

Participant milestones
Measure	E/C/F/TAF (12 - 17 Years of Age) Participants 12 - 17 years of age received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 48 weeks. Following completion of 48 weeks of treatment, eligible participants 12 - 17 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase.	E/C/F/TAF (≥ 18 Years of Age) Participants 18 years of age or older received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks. Following completion of 48 weeks of treatment, eligible participants ≥ 18 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase. Note: Participants from Gilead Study GS-US-162-0112 were allowed to roll over into this Study GS-US-292-1515 even if they were 18 years or older at the time of screening.
Overall Study STARTED	50	10
Overall Study COMPLETED	46	10
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	E/C/F/TAF (12 - 17 Years of Age) Participants 12 - 17 years of age received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 48 weeks. Following completion of 48 weeks of treatment, eligible participants 12 - 17 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase.	E/C/F/TAF (≥ 18 Years of Age) Participants 18 years of age or older received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks. Following completion of 48 weeks of treatment, eligible participants ≥ 18 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase. Note: Participants from Gilead Study GS-US-162-0112 were allowed to roll over into this Study GS-US-292-1515 even if they were 18 years or older at the time of screening.
Overall Study Death	1	0
Overall Study Pregnancy	1	0
Overall Study Withdrew Consent	1	0
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	E/C/F/TAF (12 - 17 Years of Age) n=50 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age	E/C/F/TAF (≥ 18 Years of Age) n=10 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older	Total n=60 Participants Total of all reporting groups
Age, Continuous	15 years STANDARD_DEVIATION 1.6 • n=5 Participants	19 years STANDARD_DEVIATION 1.2 • n=7 Participants	16 years STANDARD_DEVIATION 2.2 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	3 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	7 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants	10 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black	49 Participants n=5 Participants	9 Participants n=7 Participants	58 Participants n=5 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment South Africa	42 Participants n=5 Participants	10 Participants n=7 Participants	52 Participants n=5 Participants
HIV-1 RNA Category < 50 copies/mL	49 Participants n=5 Participants	9 Participants n=7 Participants	58 Participants n=5 Participants
HIV-1 RNA Category ≥ 50 copies/mL	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
CD4 Cell Count	753 cells/µL STANDARD_DEVIATION 222.5 • n=5 Participants	776 cells/µL STANDARD_DEVIATION 179.9 • n=7 Participants	757 cells/µL STANDARD_DEVIATION 214.8 • n=5 Participants
CD4 Percentage	34.3 percentage STANDARD_DEVIATION 6.72 • n=5 Participants	35.9 percentage STANDARD_DEVIATION 6.53 • n=7 Participants	34.6 percentage STANDARD_DEVIATION 6.66 • n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 48

Population: Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.

The percentage of participants experiencing any treatment-emergent serious adverse event was summarized.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (12 - 17 Years of Age) n=50 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age	E/C/F/TAF (≥ 18 Years of Age) n=10 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
Incidence of Treatment-Emergent Serious Adverse Events	4.0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Up to Week 48

Population: Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.

The percentage of participants experiencing any treatment-emergent adverse event was summarized.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (12 - 17 Years of Age) n=50 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age	E/C/F/TAF (≥ 18 Years of Age) n=10 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
Incidence of Treatment-Emergent Adverse Events	92.0 percentage of participants	100.0 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Full Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.

The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (12 - 17 Years of Age) n=50 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age	E/C/F/TAF (≥ 18 Years of Age) n=10 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis)	96.0 percentage of participants Interval 86.3 to 99.5	100.0 percentage of participants Interval 69.2 to 100.0

SECONDARY outcome

Timeframe: Week 48

Population: Full Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.

The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (12 - 17 Years of Age) n=50 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age	E/C/F/TAF (≥ 18 Years of Age) n=10 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis)	90.0 percentage of participants Interval 78.2 to 96.7	100.0 percentage of participants Interval 69.2 to 100.0

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: Participants in the Full Analysis Set with on-treatment data were analyzed.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (12 - 17 Years of Age) n=50 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age	E/C/F/TAF (≥ 18 Years of Age) n=10 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
Change From Baseline in CD4 Cell Count at Week 24	-72 cells/µL Standard Deviation 189.8	-85 cells/µL Standard Deviation 245.9

SECONDARY outcome

Timeframe: Baseline; Week 48

Population: Participants in the Full Analysis Set with on-treatment data were analyzed.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (12 - 17 Years of Age) n=48 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age	E/C/F/TAF (≥ 18 Years of Age) n=10 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
Change From Baseline in CD4 Cell Count at Week 48	-43 cells/µL Standard Deviation 201.1	-41 cells/µL Standard Deviation 143.0

SECONDARY outcome

Timeframe: Baseline; Week 24

Population: Participants in the Full Analysis Set with on-treatment data were analyzed.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (12 - 17 Years of Age) n=50 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age	E/C/F/TAF (≥ 18 Years of Age) n=10 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
Change From Baseline in CD4 Percentage at Week 24	-0.6 percentage Standard Deviation 5.46	-0.6 percentage Standard Deviation 5.46

SECONDARY outcome

Timeframe: Baseline; Week 48

Population: Participants in the Full Analysis Set with on-treatment data were analyzed.

Outcome measures

Outcome measures
Measure	E/C/F/TAF (12 - 17 Years of Age) n=48 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age	E/C/F/TAF (≥ 18 Years of Age) n=10 Participants E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
Change From Baseline in CD4 Percentage at Week 48	-0.1 percentage Standard Deviation 3.95	-1.1 percentage Standard Deviation 7.29

Adverse Events

E/C/F/TAF (12 - 17 Years of Age)

Serious events: 3 serious events

Other events: 42 other events

Deaths: 1 deaths

E/C/F/TAF (≥ 18 Years of Age)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	E/C/F/TAF (12 - 17 Years of Age) n=50 participants at risk E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age. Following completion of 48 weeks of treatment, eligible participants 12 - 17 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase.	E/C/F/TAF (≥ 18 Years of Age) n=10 participants at risk E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older. Following completion of 48 weeks of treatment, eligible participants ≥ 18 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase.
Gastrointestinal disorders Vomiting	2.0% 1/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	0.00% 0/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
General disorders Electrocution	2.0% 1/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	0.00% 0/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	2.0% 1/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	0.00% 0/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.

Other adverse events

Additional Information

Clinical Trial Disclosures & Data Transparency

Gilead Sciences

Phone: 1-833-445-3230

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER

Measure	E/C/F/TAF (12 - 17 Years of Age) n=50 participants at risk E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age. Following completion of 48 weeks of treatment, eligible participants 12 - 17 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase.	E/C/F/TAF (≥ 18 Years of Age) n=10 participants at risk E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older. Following completion of 48 weeks of treatment, eligible participants ≥ 18 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase.
Blood and lymphatic system disorders Anaemia	6.0% 3/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	0.00% 0/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Blood and lymphatic system disorders Lymphadenopathy	2.0% 1/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Blood and lymphatic system disorders Neutropenia	6.0% 3/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	0.00% 0/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	4.0% 2/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain upper	6.0% 3/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Gastrointestinal disorders Anal fissure	0.00% 0/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	4.0% 2/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	14.0% 7/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	20.0% 2/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	16.0% 8/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
General disorders Axillary pain	0.00% 0/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
General disorders Chest pain	0.00% 0/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
General disorders Malaise	4.0% 2/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
General disorders Pain	0.00% 0/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Infections and infestations Acarodermatitis	6.0% 3/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	0.00% 0/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Infections and infestations Bronchitis	6.0% 3/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	0.00% 0/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Infections and infestations Gastroenteritis	4.0% 2/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Infections and infestations Herpes simplex	0.00% 0/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Infections and infestations Lower respiratory tract infection	6.0% 3/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	0.00% 0/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Infections and infestations Oral herpes	2.0% 1/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	20.0% 2/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Infections and infestations Otitis media	4.0% 2/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Infections and infestations Pharyngitis	6.0% 3/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	0.00% 0/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Infections and infestations Sinusitis	6.0% 3/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Infections and infestations Sinusitis bacterial	0.00% 0/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Infections and infestations Tonsillitis	0.00% 0/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	22.0% 11/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	60.0% 6/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	8.0% 4/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	0.00% 0/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Infections and infestations Viral upper respiratory tract infection	14.0% 7/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	0.00% 0/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Thermal burn	6.0% 3/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	0.00% 0/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Investigations Alanine aminotransferase increased	0.00% 0/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Investigations Blood creatine phosphokinase increased	0.00% 0/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Investigations Bone density decreased	4.0% 2/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Investigations Vitamin D decreased	14.0% 7/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	0.00% 0/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Investigations Weight decreased	2.0% 1/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	8.0% 4/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	2.0% 1/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	6.0% 3/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	0.00% 0/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	2.0% 1/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Nervous system disorders Dizziness	6.0% 3/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	0.00% 0/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Nervous system disorders Headache	12.0% 6/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	20.0% 2/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Reproductive system and breast disorders Dysmenorrhoea	6.0% 3/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	0.00% 0/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	24.0% 12/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	50.0% 5/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	6.0% 3/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	30.0% 3/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Acne	12.0% 6/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	0.00% 0/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	2.0% 1/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	10.0% 1/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash	10.0% 5/50 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.	0.00% 0/10 • Up to 128 weeks plus 30 days Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.