Trial Outcomes & Findings for A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Autoinjector (PFS+AI) in Healthy Participants (NCT NCT03961308)

NCT ID: NCT03961308

Last Updated: 2019-11-14

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 204 participants
• Primary outcome timeframe: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
• Results posted on: 2019-11-14

Participant Flow

Participants took part in the study at 1 investigative site in the United States from 12 March 2018 to 21 November 2018.

Healthy participants were enrolled in one of the two device presentation groups to receive vedolizumab subcutaneous (SC) 108 milligram (mg) using a prefilled syringe (PFS) or using an investigational device. Primary objective was to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).

Participant milestones

Measure	Group A: Vedolizumab SC PFS Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.	Group B: Vedolizumab SC Investigational Device Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
Overall Study STARTED	102	102
Overall Study COMPLETED	100	100
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Group A: Vedolizumab SC PFS Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.	Group B: Vedolizumab SC Investigational Device Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
Overall Study Withdrawal by Subject	1	0
Overall Study Other	1	0
Overall Study Lost to Follow-up	0	1
Overall Study Adverse Event	0	1

Baseline Characteristics

A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Autoinjector (PFS+AI) in Healthy Participants

Baseline characteristics by cohort

Measure	Group A: Vedolizumab SC PFS n=102 Participants Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.	Group B: Vedolizumab SC Investigational Device n=102 Participants Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.	Total n=204 Participants Total of all reporting groups
Age, Continuous	37.4 years STANDARD_DEVIATION 11.96 • n=5 Participants	35.7 years STANDARD_DEVIATION 13.96 • n=7 Participants	36.6 years STANDARD_DEVIATION 12.99 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	43 Participants n=7 Participants	85 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	59 Participants n=7 Participants	119 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	94 Participants n=5 Participants	90 Participants n=7 Participants	184 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 American Indian or Alaska Native	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized White, Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	77 Participants n=5 Participants	82 Participants n=7 Participants	159 Participants n=5 Participants
Race/Ethnicity, Customized White, American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White, Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized White, Native Hawaiian or Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	102 Participants n=5 Participants	102 Participants n=7 Participants	204 Participants n=5 Participants
Weight	73.93 kilogram (kg) STANDARD_DEVIATION 9.288 • n=5 Participants	71.61 kilogram (kg) STANDARD_DEVIATION 9.971 • n=7 Participants	72.77 kilogram (kg) STANDARD_DEVIATION 9.682 • n=5 Participants
Height	173.8 centimeter (cm) STANDARD_DEVIATION 8.76 • n=5 Participants	170.9 centimeter (cm) STANDARD_DEVIATION 9.78 • n=7 Participants	172.3 centimeter (cm) STANDARD_DEVIATION 9.37 • n=5 Participants
Body mass index (BMI)	24.727 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.3575 • n=5 Participants	24.580 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.5635 • n=7 Participants	24.653 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.4577 • n=5 Participants

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose

Population: The pharmacokinetic (PK) set included all participants who received study drug and had at least one measurable serum concentration. The number of participants analyzed includes only those participants who had data available for this measure.

Outcome measures

Measure	Group A: Vedolizumab SC PFS n=97 Participants Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.	Group B: Vedolizumab SC Investigational Device n=97 Participants Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC	402.8 microgram*day per milliliter(mcg*day/mL) Geometric Coefficient of Variation 38.3	452.3 microgram*day per milliliter(mcg*day/mL) Geometric Coefficient of Variation 39.0

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose

Population: The PK set included all participants who received study drug and had at least one measurable serum concentration. The number of participants analyzed includes only those participants who had data available for this measure.

Outcome measures

Measure	Group A: Vedolizumab SC PFS n=95 Participants Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.	Group B: Vedolizumab SC Investigational Device n=96 Participants Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC	424.3 mcg*day/mL Geometric Coefficient of Variation 35.6	479.8 mcg*day/mL Geometric Coefficient of Variation 29.8

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose

Population: The PK set included all participants who received study drug and had at least one measurable serum concentration. The number of participants analyzed includes only those participants who had data available for this measure.

Outcome measures

Measure	Group A: Vedolizumab SC PFS n=99 Participants Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.	Group B: Vedolizumab SC Investigational Device n=99 Participants Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
Cmax: Maximum Observed Serum Concentration for Vedolizumab SC	12.60 microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 29.1	13.66 microgram per milliliter (mcg/mL) Geometric Coefficient of Variation 27.6

Adverse Events

Group A: Vedolizumab SC PFS

Serious events: 1 serious events

Other events: 70 other events

Deaths: 0 deaths

Group B: Vedolizumab SC Investigational Device

Serious events: 0 serious events

Other events: 72 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group A: Vedolizumab SC PFS n=102 participants at risk Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.	Group B: Vedolizumab SC Investigational Device n=102 participants at risk Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
Gastrointestinal disorders Abdominal pain	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Measure	Group A: Vedolizumab SC PFS n=102 participants at risk Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.	Group B: Vedolizumab SC Investigational Device n=102 participants at risk Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
Cardiac disorders Palpitations	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Ear and labyrinth disorders Cerumen impaction	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Eye disorders Eye pruritus	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal discomfort	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal distension	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain	4.9% 5/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain lower	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Anal fissure	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Constipation	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Diarrhoea	2.9% 3/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.9% 3/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Flatulence	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Haematochezia	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea	2.0% 2/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.9% 3/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Proctalgia	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Tooth impacted	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Toothache	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Vomiting	2.9% 3/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.0% 2/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Exercise tolerance decreased	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Fatigue	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.0% 2/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Feeling drunk	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Influenza like illness	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Injection site erythema	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.9% 4/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Injection site induration	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Injection site pain	44.1% 45/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	52.9% 54/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Injection site pruritus	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Nodule	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pain	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pyrexia	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Vessel puncture site pain	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Bacterial vulvovaginitis	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Chlamydial infection	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Conjunctivitis	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Diverticulitis	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Ear infection	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Herpes zoster	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Oral herpes	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Otitis externa	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pharyngitis	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pharyngitis streptococcal	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pneumonia	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Respiratory tract infection	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Upper respiratory tract infection	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.9% 3/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Viral infection	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Laceration	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.0% 2/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Nerve injury	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Radius fracture	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Skin abrasion	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Wound	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Neutrophil count decreased	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Weight increased	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.0% 2/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Abnormal weight gain	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthritis	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Back pain	2.9% 3/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.9% 3/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.0% 2/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.0% 2/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.9% 3/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Clumsiness	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dizziness	2.0% 2/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dysarthria	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dysgeusia	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Fine motor skill dysfunction	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	7.8% 8/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.9% 6/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Hypoaesthesia	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Memory impairment	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Migraine	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Presyncope	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Anxiety	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Irritability	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Haematuria	2.0% 2/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Pollakiuria	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Urinary retention	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Reproductive system and breast disorders Vulvovaginal pruritus	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Dry throat	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.9% 4/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.0% 2/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Dermatitis contact	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Erythema	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Vascular disorders Hot flush	0.98% 1/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/102 • Treatment-emergent adverse events are adverse events that started after the administration of the study drug and no more than Day 127 At each visit the investigator had to assess any occurrence of adverse events. Participants may report AEs occurring at any other time during the study. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: trialdisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
• Publication restrictions are in place

Restriction type: OTHER