Trial Outcomes & Findings for A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants (NCT NCT03948581)
NCT ID: NCT03948581
Last Updated: 2022-07-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
102 participants
Primary outcome timeframe
Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Results posted on
2022-07-29
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 21 February 2018 to 21 September 2018.
Healthy participants were enrolled in one of the two device presentation groups to receive vedolizumab subcutaneous (SC) 108 milligram (mg) using 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
|
51
|
51
|
|
Overall Study
COMPLETED
|
51
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
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
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants
Baseline characteristics by cohort
| Measure |
Group A: Vedolizumab SC PFS
n=51 Participants
Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.
|
Group B: Vedolizumab SC Investigational Device
n=51 Participants
Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 12.59 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 11.46 • n=7 Participants
|
36.5 years
STANDARD_DEVIATION 11.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 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
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/AfricanAmerican,American Indian/AlaskaNative
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
36 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Black or African American, Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Weight
|
67.43 kilogram (kg)
STANDARD_DEVIATION 8.411 • n=5 Participants
|
71.56 kilogram (kg)
STANDARD_DEVIATION 11.289 • n=7 Participants
|
69.49 kilogram (kg)
STANDARD_DEVIATION 10.120 • n=5 Participants
|
|
Height
|
167.0 centimeter (cm)
STANDARD_DEVIATION 8.79 • n=5 Participants
|
170.0 centimeter (cm)
STANDARD_DEVIATION 11.22 • n=7 Participants
|
168.5 centimeter (cm)
STANDARD_DEVIATION 10.14 • n=5 Participants
|
|
Body mass index (BMI)
|
24.167 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.5858 • n=5 Participants
|
24.595 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.3885 • n=7 Participants
|
24.381 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.4861 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to Day 127) post-dosePopulation: Pharmacokinetic (PK) set: Participants received study drug and had at least one measurable serum concentration. Number of participants analyzed includes only those participants who had data available for this measure. It was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
Outcome measures
| Measure |
Group A: Vedolizumab SC PFS
n=51 Participants
Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.
|
Group B: Vedolizumab SC Investigational Device
n=50 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
|
492.6 microgram*day per milliliter(mcg*day/mL)
Geometric Coefficient of Variation 22.5
|
455.4 microgram*day per milliliter(mcg*day/mL)
Geometric Coefficient of Variation 34.4
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to Day 127) post-dosePopulation: The PK set: Participants who received study drug and had at least one measurable serum concentration. Number of participants analyzed includes only those participants who had data available for this measure. It was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
Outcome measures
| Measure |
Group A: Vedolizumab SC PFS
n=51 Participants
Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.
|
Group B: Vedolizumab SC Investigational Device
n=49 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
|
504.4 mcg*day/mL
Geometric Coefficient of Variation 22.0
|
478.4 mcg*day/mL
Geometric Coefficient of Variation 30.7
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to Day 127) post-dosePopulation: The PK set included all participants who received study drug and had at least one measurable serum concentration. It was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
Outcome measures
| Measure |
Group A: Vedolizumab SC PFS
n=51 Participants
Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.
|
Group B: Vedolizumab SC Investigational Device
n=51 Participants
Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
|
|---|---|---|
|
Cmax: Maximum Observed Serum Concentration for Vedolizumab SC
|
15.42 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 19.9
|
14.86 microgram per milliliter (mcg/mL)
Geometric Coefficient of Variation 24.4
|
Adverse Events
Group A: Vedolizumab SC PFS
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Group B: Vedolizumab SC Investigational Device
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A: Vedolizumab SC PFS
n=51 participants at risk
Vedolizumab SC 108 mg, injection, subcutaneously using a PFS, once on Day 1.
|
Group B: Vedolizumab SC Investigational Device
n=51 participants at risk
Vedolizumab SC 108 mg, injection, subcutaneously using an investigational device, once on Day 1.
|
|---|---|---|
|
Eye disorders
Eyelid odema
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Eye disorders
Vision blurred
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Gastrointestinal disorders
Aphthous ulcer
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Gastrointestinal disorders
Nausea
|
3.9%
2/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
3.9%
2/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
General disorders
Chest discomfort
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
General disorders
Influenza like illness
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
General disorders
Injection site erythema
|
5.9%
3/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
11.8%
6/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
General disorders
Injection site induration
|
13.7%
7/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
9.8%
5/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
General disorders
Injection site pain
|
52.9%
27/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
52.9%
27/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
General disorders
Thirst
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
5.9%
3/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Infections and infestations
Oral herpes
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Infections and infestations
Viral infection
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Investigations
Weight decreased
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Investigations
Weight increased
|
5.9%
3/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
11.8%
6/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
2/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Nervous system disorders
Headache
|
3.9%
2/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
11.8%
6/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Nervous system disorders
Presyncope
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Nervous system disorders
Somnolence
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Renal and urinary disorders
Haematuria
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
|
Vascular disorders
Flushing
|
2.0%
1/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
0.00%
0/51 • 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. The study was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).
|
Additional Information
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