Trial Outcomes & Findings for A Study to Evaluate the Bioequivalence of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants (NCT NCT04255862)
NCT ID: NCT04255862
Last Updated: 2025-04-10
Results Overview
AUC is the area under the bimekizumab plasma concentration-time curve from time zero (Day 1 predose) to infinity.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
71 participants
Primary outcome timeframe
From Baseline (Day 1 predose) at predefined time points (up to Day 140)
Results posted on
2025-04-10
Participant Flow
The study started to enroll study participants in February 2020 and concluded in April 2021.
Participant Flow refers to the Randomized Set (RS) which consisted of all randomized study participants.
Participant milestones
| Measure |
Bimekizumab-SS-2mL (Test 1)
Participants randomized to this arm received a single dose of bimekizumab 320 milligrams (mg) administered as a subcutaneous injection using a 2 milliliter (mL) safety syringe (SS) on Day 1 of the study.
|
Bimekizumab-SS-2x1mL (Reference 1)
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL SS on Day 1 of the study.
|
Bimekizumab-AI-2mL (Test 2)
Participants randomized to this arm received a single dose of bimekizumab 320 mg administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference 2)
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
17
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Bioequivalence of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants
Baseline characteristics by cohort
| Measure |
Bimekizumab-SS-2mL (Test 1)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 milligrams (mg) administered as a subcutaneous injection using a 2 milliliter (mL) safety syringe (SS) on Day 1 of the study.
|
Bimekizumab-SS-2x1mL (Reference 1)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL SS on Day 1 of the study.
|
Bimekizumab-AI-2mL (Test 2)
n=17 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference 2)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
66 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Age, Continuous
|
52.6 years
STANDARD_DEVIATION 12.8 • n=99 Participants
|
51.1 years
STANDARD_DEVIATION 15.8 • n=107 Participants
|
46.8 years
STANDARD_DEVIATION 15.7 • n=206 Participants
|
46.7 years
STANDARD_DEVIATION 15.7 • n=7 Participants
|
49.3 years
STANDARD_DEVIATION 15.0 • n=31 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
51 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
69 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other/Black
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other/Caucasian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
71 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1 predose) at predefined time points (up to Day 140)Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK variables and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
AUC is the area under the bimekizumab plasma concentration-time curve from time zero (Day 1 predose) to infinity.
Outcome measures
| Measure |
Bimekizumab-SS-2mL (Test 1)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 milligrams (mg) administered as a subcutaneous injection using a 2 milliliter (mL) safety syringe (SS) on Day 1 of the study.
|
Bimekizumab-SS-2x1mL (Reference 1)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL SS on Day 1 of the study.
|
Bimekizumab-AI-2mL (Test 2)
n=17 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference 2)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) for a Single Dose Bimekizumab (BKZ)
|
1665 days*micrograms/milliliter (days*ug/mL)
Geometric Coefficient of Variation 34.2
|
1610 days*micrograms/milliliter (days*ug/mL)
Geometric Coefficient of Variation 31.3
|
1560 days*micrograms/milliliter (days*ug/mL)
Geometric Coefficient of Variation 19.1
|
1357 days*micrograms/milliliter (days*ug/mL)
Geometric Coefficient of Variation 35.5
|
PRIMARY outcome
Timeframe: From Baseline (Day 1 predose) at predefined time points to the last quantifiable concentration (Day 140)Population: The PK-PPS was a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK variables and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
AUC0-t is the area under the bimekizumab plasma concentration-time curve from time zero (Day 1 predose) to the last observed quantifiable concentration.
Outcome measures
| Measure |
Bimekizumab-SS-2mL (Test 1)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 milligrams (mg) administered as a subcutaneous injection using a 2 milliliter (mL) safety syringe (SS) on Day 1 of the study.
|
Bimekizumab-SS-2x1mL (Reference 1)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL SS on Day 1 of the study.
|
Bimekizumab-AI-2mL (Test 2)
n=17 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference 2)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for a Single Dose Bimekizumab (BKZ)
|
1551 days*ug/mL
Geometric Coefficient of Variation 31.4
|
1509 days*ug/mL
Geometric Coefficient of Variation 29.2
|
1469 days*ug/mL
Geometric Coefficient of Variation 17.5
|
1296 days*ug/mL
Geometric Coefficient of Variation 33.7
|
PRIMARY outcome
Timeframe: From Baseline (Day 1 predose) at predefined time points (up to Day 140)Population: The PK-PPS was a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK variables and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
Cmax is the maximum observed plasma concentration.
Outcome measures
| Measure |
Bimekizumab-SS-2mL (Test 1)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 milligrams (mg) administered as a subcutaneous injection using a 2 milliliter (mL) safety syringe (SS) on Day 1 of the study.
|
Bimekizumab-SS-2x1mL (Reference 1)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL SS on Day 1 of the study.
|
Bimekizumab-AI-2mL (Test 2)
n=17 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference 2)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) for a Single Dose Bimekizumab (BKZ)
|
43.56 ug/mL
Geometric Coefficient of Variation 26.8
|
41.90 ug/mL
Geometric Coefficient of Variation 23.9
|
42.23 ug/mL
Geometric Coefficient of Variation 20.3
|
36.94 ug/mL
Geometric Coefficient of Variation 28.2
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)Population: The FAS consisted of all randomized study participants who received full or partial IMP according to the treatment the study participants actually received.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment.
Outcome measures
| Measure |
Bimekizumab-SS-2mL (Test 1)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 milligrams (mg) administered as a subcutaneous injection using a 2 milliliter (mL) safety syringe (SS) on Day 1 of the study.
|
Bimekizumab-SS-2x1mL (Reference 1)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL SS on Day 1 of the study.
|
Bimekizumab-AI-2mL (Test 2)
n=17 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference 2)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) From Baseline to End of Safety Follow-Up
|
66.7 percentage of participants
|
44.4 percentage of participants
|
70.6 percentage of participants
|
38.9 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)Population: The FAS consisted of all randomized study participants who received full or partial IMP according to the treatment the study participants actually received.
A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose: a. Results in death, b. Is life-threatening, c. Requires inpatient hospitalization or prolongation of existing hospitalization, d. Results in persistent disability/incapacity, e. Is a congenital anomaly/ birth defect, f. Other important medical events which based on appropriate medical judgment, jeopardized the study participant and required medical or surgical intervention to prevent any of the above.
Outcome measures
| Measure |
Bimekizumab-SS-2mL (Test 1)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 milligrams (mg) administered as a subcutaneous injection using a 2 milliliter (mL) safety syringe (SS) on Day 1 of the study.
|
Bimekizumab-SS-2x1mL (Reference 1)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL SS on Day 1 of the study.
|
Bimekizumab-AI-2mL (Test 2)
n=17 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference 2)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE) From Baseline to End of Safety Follow-Up
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1 predose) at predefined time points (up to Day 140)Population: The PK-PPS was a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK variables and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
Apparent terminal half-life, reported in units of days, as determined via simple linear regression (slope=-lambdaz) of natural log (ln) concentration versus time for data points in the terminal phase of the concentration-time curve. t1/2 is calculated as ln2/lambdaz.
Outcome measures
| Measure |
Bimekizumab-SS-2mL (Test 1)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 milligrams (mg) administered as a subcutaneous injection using a 2 milliliter (mL) safety syringe (SS) on Day 1 of the study.
|
Bimekizumab-SS-2x1mL (Reference 1)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL SS on Day 1 of the study.
|
Bimekizumab-AI-2mL (Test 2)
n=17 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference 2)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2)
|
28.21 days
Geometric Coefficient of Variation 17.3
|
27.24 days
Geometric Coefficient of Variation 16.8
|
25.73 days
Geometric Coefficient of Variation 27.8
|
22.84 days
Geometric Coefficient of Variation 28.7
|
SECONDARY outcome
Timeframe: From Baseline (Day 1 predose) at predefined time points (up to Day 140)Population: The PK-PPS was a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK variables and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
tmax is the time to reach maximum plasma concentration.
Outcome measures
| Measure |
Bimekizumab-SS-2mL (Test 1)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 milligrams (mg) administered as a subcutaneous injection using a 2 milliliter (mL) safety syringe (SS) on Day 1 of the study.
|
Bimekizumab-SS-2x1mL (Reference 1)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL SS on Day 1 of the study.
|
Bimekizumab-AI-2mL (Test 2)
n=17 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference 2)
n=18 Participants
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|---|---|
|
Time of Occurrence of the Maximum Observed Concentration (Tmax) of a Single Dose Bimekizumab (BKZ)
|
6.981 days
Interval 2.99 to 15.0
|
6.988 days
Interval 2.92 to 12.0
|
6.943 days
Interval 3.98 to 12.0
|
6.972 days
Interval 3.0 to 8.98
|
Adverse Events
Bimekizumab-SS-2mL (Test 1)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Bimekizumab-SS-2x1mL (Reference 1)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Bimekizumab-AI-2mL (Test 2)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Bimekizumab-AI-2x1mL (Reference 2)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bimekizumab-SS-2mL (Test 1)
n=18 participants at risk
Participants randomized to this arm received a single dose of bimekizumab 320 milligrams (mg) administered as a subcutaneous injection using a 2 milliliter (mL) safety syringe (SS) on Day 1 of the study.
|
Bimekizumab-SS-2x1mL (Reference 1)
n=18 participants at risk
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL SS on Day 1 of the study.
|
Bimekizumab-AI-2mL (Test 2)
n=17 participants at risk
Participants randomized to this arm received a single dose of bimekizumab 320 mg administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference 2)
n=18 participants at risk
Participants randomized to this arm received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|---|---|
|
Eye disorders
Eyelid haematoma
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 2 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
11.8%
2/17 • Number of events 2 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.9%
1/17 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Gastrointestinal disorders
Gingival discomfort
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.9%
1/17 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.9%
1/17 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
11.1%
2/18 • Number of events 2 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
General disorders
Injection site haematoma
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
16.7%
3/18 • Number of events 3 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
General disorders
Injection site pain
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.9%
1/17 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
General disorders
Pyrexia
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
General disorders
Influenza like illness
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.9%
1/17 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
General disorders
Pain
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Infections and infestations
Oral herpes
|
11.1%
2/18 • Number of events 2 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Infections and infestations
Angular cheilitis
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Infections and infestations
Erythema migrans
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Infections and infestations
Furuncle
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.9%
1/17 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.9%
1/17 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Number of events 2 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
11.1%
2/18 • Number of events 2 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
23.5%
4/17 • Number of events 4 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.9%
1/17 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Nervous system disorders
Headache
|
22.2%
4/18 • Number of events 8 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
22.2%
4/18 • Number of events 5 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
17.6%
3/17 • Number of events 5 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 2 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.9%
1/17 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 2 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.9%
1/17 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
11.1%
2/18 • Number of events 2 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
2/18 • Number of events 2 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.9%
1/17 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
|
Vascular disorders
Hot flush
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/18 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
0.00%
0/17 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
5.6%
1/18 • Number of events 1 • From Baseline (Day 1) to end of Safety Follow-Up Visit (up to Day 140)
Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. TEAEs were reported based on the Full Analysis Set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60