Trial Outcomes & Findings for Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants (NCT NCT04987333)
NCT ID: NCT04987333
Last Updated: 2024-03-29
Results Overview
Blood samples were collected to determine PK parameters.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43
Results posted on
2024-03-29
Participant Flow
Participants were enrolled at 1 research center in the United Kingdom from August 2021 to October 2022.
Participant milestones
| Measure |
Group 1: Chinese Participants - Efavaleukin Alfa (Dose Level 1)
Chinese participants who received efavaleukin alfa administered as one subcutaneous (SC) injection at dose level 1 (low).
|
Group 2: Chinese Participants - Efavaleukin Alfa (Dose Level 2)
Chinese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 3: Japanese Participants -Efavaleukin Alfa (Dose Level 2)
Japanese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 4: Caucasian Participants - Efavaleukin Alfa (Dose Level 2)
Caucasian participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants
Baseline characteristics by cohort
| Measure |
Group 1: Chinese Participants - Efavaleukin Alfa (Dose Level 1)
n=8 Participants
Chinese participants who received efavaleukin alfa administered as one subcutaneous (SC) injection at dose level 1 (low).
|
Group 2: Chinese Participants - Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Chinese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 3: Japanese Participants -Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Japanese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 4: Caucasian Participants - Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Caucasian participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
27.9 Years
STANDARD_DEVIATION 4.55 • n=5 Participants
|
28.3 Years
STANDARD_DEVIATION 4.86 • n=7 Participants
|
29.5 Years
STANDARD_DEVIATION 4.11 • n=5 Participants
|
37.9 Years
STANDARD_DEVIATION 12.01 • n=4 Participants
|
30.9 Years
STANDARD_DEVIATION 7.97 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43Population: Pharmacokinetic (PK) population: all participants who received at least 1 dose of efavaleukin alfa and had evaluable PK data.
Blood samples were collected to determine PK parameters.
Outcome measures
| Measure |
Group 1: Chinese Participants - Efavaleukin Alfa (Dose Level 1)
n=8 Participants
Chinese participants who received efavaleukin alfa administered as one subcutaneous (SC) injection at dose level 1 (low).
|
Group 2: Chinese Participants - Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Chinese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 3: Japanese Participants -Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Japanese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 4: Caucasian Participants - Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Caucasian participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Efavaleukin Alfa
|
26.9 ng/mL
Geometric Coefficient of Variation 52.1
|
41.6 ng/mL
Geometric Coefficient of Variation 33.4
|
48.1 ng/mL
Geometric Coefficient of Variation 33.0
|
56.1 ng/mL
Geometric Coefficient of Variation 47.7
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43Population: PK population: all participants who received at least 1 dose of efavaleukin alfa and had evaluable PK data.
Blood samples were collected to determine PK parameters.
Outcome measures
| Measure |
Group 1: Chinese Participants - Efavaleukin Alfa (Dose Level 1)
n=8 Participants
Chinese participants who received efavaleukin alfa administered as one subcutaneous (SC) injection at dose level 1 (low).
|
Group 2: Chinese Participants - Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Chinese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 3: Japanese Participants -Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Japanese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 4: Caucasian Participants - Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Caucasian participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
|---|---|---|---|---|
|
Time of the Maximum Observed Serum Concentration (Tmax) of Efavaleukin Alfa
|
24.0 hours
Interval 24.0 to 48.1
|
24.0 hours
Interval 16.0 to 48.0
|
24.0 hours
Interval 16.0 to 48.0
|
20.0 hours
Interval 6.0 to 72.1
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43Population: PK population: all participants who received at least 1 dose of efavaleukin alfa and had evaluable PK data.
Blood samples were collected to determine PK parameters.
Outcome measures
| Measure |
Group 1: Chinese Participants - Efavaleukin Alfa (Dose Level 1)
n=8 Participants
Chinese participants who received efavaleukin alfa administered as one subcutaneous (SC) injection at dose level 1 (low).
|
Group 2: Chinese Participants - Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Chinese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 3: Japanese Participants -Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Japanese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 4: Caucasian Participants - Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Caucasian participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
|---|---|---|---|---|
|
Area Under the Serum Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Efavaleukin Alfa
|
1530 hr*ng/mL
Geometric Coefficient of Variation 70.0
|
2330 hr*ng/mL
Geometric Coefficient of Variation 38.8
|
2590 hr*ng/mL
Geometric Coefficient of Variation 29.0
|
2660 hr*ng/mL
Geometric Coefficient of Variation 44.2
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43Population: PK population: all participants who received at least 1 dose of efavaleukin alfa and had evaluable PK data.
Blood samples were collected to determine PK parameters.
Outcome measures
| Measure |
Group 1: Chinese Participants - Efavaleukin Alfa (Dose Level 1)
n=7 Participants
Chinese participants who received efavaleukin alfa administered as one subcutaneous (SC) injection at dose level 1 (low).
|
Group 2: Chinese Participants - Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Chinese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 3: Japanese Participants -Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Japanese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 4: Caucasian Participants - Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Caucasian participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
|---|---|---|---|---|
|
Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUCinf) of Efavaleukin Alfa
|
1700 hr*ng/mL
Geometric Coefficient of Variation 66.7
|
2350 hr*ng/mL
Geometric Coefficient of Variation 38.1
|
2590 hr*ng/mL
Geometric Coefficient of Variation 29.0
|
2500 hr*ng/mL
Geometric Coefficient of Variation 43.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 43Population: Safety population: all participants who received at least 1 dose of efavaleukin alfa and had at least 1 post-dose safety assessment.
Adverse events (AEs) were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment. Any clinically significant changes in physical examinations, clinical laboratory tests and vital signs were recorded as TEAEs. Serious AEs (SAEs) were defined as any event that met at least 1 of the following serious criteria: * Resulted in death (fatal) * Required in-patient hospitalization or prolongation of existing hospitalization * Resulted in persistent or significant disability/incapacity * A congenital anomaly/birth defect * Other medically important serious event
Outcome measures
| Measure |
Group 1: Chinese Participants - Efavaleukin Alfa (Dose Level 1)
n=8 Participants
Chinese participants who received efavaleukin alfa administered as one subcutaneous (SC) injection at dose level 1 (low).
|
Group 2: Chinese Participants - Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Chinese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 3: Japanese Participants -Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Japanese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 4: Caucasian Participants - Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Caucasian participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
|---|---|---|---|---|
|
Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)
All TEAEs
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)
Serious TEAEs
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 43Population: Safety population: all participants who received at least 1 dose of efavaleukin alfa and had at least 1 post-dose safety assessment.
Number of participants who tested positive for developing anti-efavaleukin alfa antibodies and/or anti-IL2 antibodies at 1 or more post-baseline time points, who had a negative or no result at baseline.
Outcome measures
| Measure |
Group 1: Chinese Participants - Efavaleukin Alfa (Dose Level 1)
n=8 Participants
Chinese participants who received efavaleukin alfa administered as one subcutaneous (SC) injection at dose level 1 (low).
|
Group 2: Chinese Participants - Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Chinese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 3: Japanese Participants -Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Japanese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 4: Caucasian Participants - Efavaleukin Alfa (Dose Level 2)
n=8 Participants
Caucasian participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
|---|---|---|---|---|
|
Number of Participants With Anti-Efavaleukin Alfa Antibodies and Anti-Interleukin 2 (IL-2) Antibodies
Anti-Efavaleukin Alfa Antibodies
|
6 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
|
Number of Participants With Anti-Efavaleukin Alfa Antibodies and Anti-Interleukin 2 (IL-2) Antibodies
Anti-IL-2 Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
Group 1: Chinese Participants - Efavaleukin Alfa (Dose Level 1)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2: Chinese Participants - Efavaleukin Alfa (Dose Level 2)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 3: Japanese Participants -Efavaleukin Alfa (Dose Level 2)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 4: Caucasian Participants - Efavaleukin Alfa (Dose Level 2)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Chinese Participants - Efavaleukin Alfa (Dose Level 1)
n=8 participants at risk
Chinese participants who received efavaleukin alfa administered as one subcutaneous (SC) injection at dose level 1 (low).
|
Group 2: Chinese Participants - Efavaleukin Alfa (Dose Level 2)
n=8 participants at risk
Chinese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 3: Japanese Participants -Efavaleukin Alfa (Dose Level 2)
n=8 participants at risk
Japanese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 4: Caucasian Participants - Efavaleukin Alfa (Dose Level 2)
n=8 participants at risk
Caucasian participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Hepatocellular injury
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
Other adverse events
| Measure |
Group 1: Chinese Participants - Efavaleukin Alfa (Dose Level 1)
n=8 participants at risk
Chinese participants who received efavaleukin alfa administered as one subcutaneous (SC) injection at dose level 1 (low).
|
Group 2: Chinese Participants - Efavaleukin Alfa (Dose Level 2)
n=8 participants at risk
Chinese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 3: Japanese Participants -Efavaleukin Alfa (Dose Level 2)
n=8 participants at risk
Japanese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
Group 4: Caucasian Participants - Efavaleukin Alfa (Dose Level 2)
n=8 participants at risk
Caucasian participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high).
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
25.0%
2/8 • Number of events 2 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
25.0%
2/8 • Number of events 2 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
General disorders
Injection site discolouration
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
General disorders
Injection site erythema
|
75.0%
6/8 • Number of events 6 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
87.5%
7/8 • Number of events 7 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
62.5%
5/8 • Number of events 5 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
87.5%
7/8 • Number of events 7 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
General disorders
Injection site pain
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
General disorders
Injection site pruritus
|
25.0%
2/8 • Number of events 2 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
50.0%
4/8 • Number of events 4 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
25.0%
2/8 • Number of events 2 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
General disorders
Injection site rash
|
25.0%
2/8 • Number of events 2 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
General disorders
Injection site swelling
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
General disorders
Pyrexia
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
General disorders
Swelling
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
25.0%
2/8 • Number of events 2 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Investigations
Sars-cov-2 test positive
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Nervous system disorders
Headache
|
37.5%
3/8 • Number of events 3 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
25.0%
2/8 • Number of events 2 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
25.0%
2/8 • Number of events 2 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
50.0%
4/8 • Number of events 4 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
25.0%
2/8 • Number of events 2 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
37.5%
3/8 • Number of events 3 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
50.0%
4/8 • Number of events 4 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
37.5%
3/8 • Number of events 3 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
37.5%
3/8 • Number of events 3 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
|
Vascular disorders
Hyperaemia
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
0.00%
0/8 • Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER