Trial Outcomes & Findings for Dose-Finding Study to Evaluate the Safety, Efficacy, & Tolerability of Multiple Doses of rAvPAL-PEG in Subjects With PKU (NCT NCT00925054)
NCT ID: NCT00925054
Last Updated: 2019-02-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Baseline, Week 1/Day 5, Week 7, Week 16/Day 106
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
Starting Dose=0.001 mg/kg
Subjects will start on rAvPAL-PEG 0.001 mg/kg
|
Starting Dose=0.003 mg/kg
Subjects will start on rAvPAL-PEG 0.003 mg/kg
|
Starting Dose=0.01 mg/kg
Subjects will start on rAvPAL-PEG 0.01 mg/kg
|
Starting Dose=0.03 mg/kg
Subjects will start on rAvPAL-PEG 0.03 mg/kg
|
Starting Dose=0.1 mg/kg
Subjects will start on rAvPAL-PEG 0.1 mg/kg
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
13
|
1
|
10
|
|
Overall Study
COMPLETED
|
7
|
8
|
12
|
0
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-Finding Study to Evaluate the Safety, Efficacy, & Tolerability of Multiple Doses of rAvPAL-PEG in Subjects With PKU
Baseline characteristics by cohort
| Measure |
Starting Dose=0.001 mg/kg
n=7 Participants
Subjects will start on rAvPAL-PEG 0.001 mg/kg
|
Starting Dose=0.003 mg/kg
n=9 Participants
Subjects will start on rAvPAL-PEG 0.003 mg/kg
|
Starting Dose=0.01 mg/kg
n=13 Participants
Subjects will start on rAvPAL-PEG 0.01 mg/kg
|
Starting Dose=0.03 mg/kg
n=1 Participants
Subjects will start on rAvPAL-PEG 0.03 mg/kg
|
Starting Dose=0.1 mg/kg
n=10 Participants
Subjects will start on rAvPAL-PEG 0.1 mg/kg
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
23.3 years
STANDARD_DEVIATION 3.45 • n=5 Participants
|
29.2 years
STANDARD_DEVIATION 5.95 • n=7 Participants
|
26.5 years
STANDARD_DEVIATION 5.65 • n=5 Participants
|
22.0 years
n=4 Participants
|
25.2 years
STANDARD_DEVIATION 8.60 • n=21 Participants
|
26.1 years
STANDARD_DEVIATION 6.35 • n=10 Participants
|
|
Age, Customized
< 18 years of age
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Age, Customized
> or = 18 years of age
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
38 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
20 Participants
n=10 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
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
39 Participants
n=10 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
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
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
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
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
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
38 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
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
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
40 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 1/Day 5, Week 7, Week 16/Day 106Population: Efficacy Population
Outcome measures
| Measure |
Starting Dose=0.001 mg/kg
n=7 Participants
Subjects with starting Dose=0.001 mg/kg
|
Starting Dose=0.003 mg/kg
n=9 Participants
Subjects with starting Dose=0.003 mg/kg
|
Starting Dose=0.01 mg/kg
n=13 Participants
Subjects with starting Dose=0.01 mg/kg
|
Starting Dose=0.03 mg/kg
n=1 Participants
Subjects with starting Dose=0.03 mg/kg
|
Starting Dose =0.1 mg/kg
n=10 Participants
Subjects with starting Dose =0.1 mg/kg
|
Total
n=40 Participants
All subjects with different starting dose combined
|
|---|---|---|---|---|---|---|
|
Blood Phenylalanine Concentrations
Baseline
|
1382.7 umol/L
Standard Deviation 191.40
|
1336.1 umol/L
Standard Deviation 344.87
|
1290.5 umol/L
Standard Deviation 459.43
|
846.0 umol/L
|
1310.3 umol/L
Standard Deviation 319.01
|
1310.8 umol/L
Standard Deviation 353.86
|
|
Blood Phenylalanine Concentrations
Week 1 Day 5
|
1405.3 umol/L
Standard Deviation 190.87
|
1276.3 umol/L
Standard Deviation 410.22
|
1216.5 umol/L
Standard Deviation 434.53
|
682.0 umol/L
|
863.7 umol/L
Standard Deviation 307.59
|
1158.5 umol/L
Standard Deviation 403.63
|
|
Blood Phenylalanine Concentrations
Week 7
|
1436.0 umol/L
Standard Deviation 274.08
|
1324.8 umol/L
Standard Deviation 304.64
|
1108.7 umol/L
Standard Deviation 510.74
|
1849.0 umol/L
|
1321.6 umol/L
Standard Deviation 350.78
|
1284.5 umol/L
Standard Deviation 405.75
|
|
Blood Phenylalanine Concentrations
week 16 Day 106
|
1284.0 umol/L
Standard Deviation 221.73
|
1049.4 umol/L
Standard Deviation 378.00
|
1093.5 umol/L
Standard Deviation 445.02
|
—
|
930.7 umol/L
Standard Deviation 331.36
|
1088.5 umol/L
Standard Deviation 367.67
|
SECONDARY outcome
Timeframe: Screening, Weeks 1-22Population: The safety population will consist of all subjects who receive any amount of study drug throughout the study duration and have post-treatment safety information (laboratory values, vital signs, adverse events, 12-lead electrocardiogram, antibodies, and physical examinations).
Outcome measures
| Measure |
Starting Dose=0.001 mg/kg
n=7 Participants
Subjects with starting Dose=0.001 mg/kg
|
Starting Dose=0.003 mg/kg
n=9 Participants
Subjects with starting Dose=0.003 mg/kg
|
Starting Dose=0.01 mg/kg
n=13 Participants
Subjects with starting Dose=0.01 mg/kg
|
Starting Dose=0.03 mg/kg
n=1 Participants
Subjects with starting Dose=0.03 mg/kg
|
Starting Dose =0.1 mg/kg
n=10 Participants
Subjects with starting Dose =0.1 mg/kg
|
Total
n=40 Participants
All subjects with different starting dose combined
|
|---|---|---|---|---|---|---|
|
Study Drug Related Adverse Events
|
5 Participants
|
9 Participants
|
11 Participants
|
1 Participants
|
10 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: safety population
Antibody against PAL (phenylalanine ammonia lyase) measured over time
Outcome measures
| Measure |
Starting Dose=0.001 mg/kg
n=7 Participants
Subjects with starting Dose=0.001 mg/kg
|
Starting Dose=0.003 mg/kg
n=9 Participants
Subjects with starting Dose=0.003 mg/kg
|
Starting Dose=0.01 mg/kg
n=13 Participants
Subjects with starting Dose=0.01 mg/kg
|
Starting Dose=0.03 mg/kg
n=1 Participants
Subjects with starting Dose=0.03 mg/kg
|
Starting Dose =0.1 mg/kg
n=10 Participants
Subjects with starting Dose =0.1 mg/kg
|
Total
n=40 Participants
All subjects with different starting dose combined
|
|---|---|---|---|---|---|---|
|
Number of Participants With Positive PAL IgG Antibody
Baseline
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
|
Number of Participants With Positive PAL IgG Antibody
Week 12
|
7 Participants
|
8 Participants
|
12 Participants
|
1 Participants
|
10 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: safety population
Antibody positivity over time
Outcome measures
| Measure |
Starting Dose=0.001 mg/kg
n=7 Participants
Subjects with starting Dose=0.001 mg/kg
|
Starting Dose=0.003 mg/kg
n=9 Participants
Subjects with starting Dose=0.003 mg/kg
|
Starting Dose=0.01 mg/kg
n=13 Participants
Subjects with starting Dose=0.01 mg/kg
|
Starting Dose=0.03 mg/kg
n=1 Participants
Subjects with starting Dose=0.03 mg/kg
|
Starting Dose =0.1 mg/kg
n=10 Participants
Subjects with starting Dose =0.1 mg/kg
|
Total
n=40 Participants
All subjects with different starting dose combined
|
|---|---|---|---|---|---|---|
|
Number of Participants With Positive PAL IgM Antibody
Baseline
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
12 Participants
|
|
Number of Participants With Positive PAL IgM Antibody
Week 12
|
4 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
10 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: safety population
Antibody positivity over time
Outcome measures
| Measure |
Starting Dose=0.001 mg/kg
n=7 Participants
Subjects with starting Dose=0.001 mg/kg
|
Starting Dose=0.003 mg/kg
n=9 Participants
Subjects with starting Dose=0.003 mg/kg
|
Starting Dose=0.01 mg/kg
n=13 Participants
Subjects with starting Dose=0.01 mg/kg
|
Starting Dose=0.03 mg/kg
n=1 Participants
Subjects with starting Dose=0.03 mg/kg
|
Starting Dose =0.1 mg/kg
n=10 Participants
Subjects with starting Dose =0.1 mg/kg
|
Total
n=40 Participants
All subjects with different starting dose combined
|
|---|---|---|---|---|---|---|
|
Number of Participants With Positive PEG IgM Antibody
Baseline
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With Positive PEG IgM Antibody
Week 16
|
7 Participants
|
7 Participants
|
8 Participants
|
0 Participants
|
9 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: safety population
Antibody positivity over time
Outcome measures
| Measure |
Starting Dose=0.001 mg/kg
n=7 Participants
Subjects with starting Dose=0.001 mg/kg
|
Starting Dose=0.003 mg/kg
n=9 Participants
Subjects with starting Dose=0.003 mg/kg
|
Starting Dose=0.01 mg/kg
n=13 Participants
Subjects with starting Dose=0.01 mg/kg
|
Starting Dose=0.03 mg/kg
n=1 Participants
Subjects with starting Dose=0.03 mg/kg
|
Starting Dose =0.1 mg/kg
n=10 Participants
Subjects with starting Dose =0.1 mg/kg
|
Total
n=40 Participants
All subjects with different starting dose combined
|
|---|---|---|---|---|---|---|
|
Number of Participants With Positive PEG IgG Antibody
Baseline
|
2 Participants
|
5 Participants
|
7 Participants
|
1 Participants
|
4 Participants
|
19 Participants
|
|
Number of Participants With Positive PEG IgG Antibody
Week 16
|
6 Participants
|
7 Participants
|
12 Participants
|
0 Participants
|
9 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: safety population
Antibody positivity over time
Outcome measures
| Measure |
Starting Dose=0.001 mg/kg
n=7 Participants
Subjects with starting Dose=0.001 mg/kg
|
Starting Dose=0.003 mg/kg
n=9 Participants
Subjects with starting Dose=0.003 mg/kg
|
Starting Dose=0.01 mg/kg
n=13 Participants
Subjects with starting Dose=0.01 mg/kg
|
Starting Dose=0.03 mg/kg
n=1 Participants
Subjects with starting Dose=0.03 mg/kg
|
Starting Dose =0.1 mg/kg
n=10 Participants
Subjects with starting Dose =0.1 mg/kg
|
Total
n=40 Participants
All subjects with different starting dose combined
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Positive Neutralizing Antibodies [NAb]
Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Positive Neutralizing Antibodies [NAb]
Week 12
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baselline, Week 12Population: safety population
Antibody positivity over time
Outcome measures
| Measure |
Starting Dose=0.001 mg/kg
n=7 Participants
Subjects with starting Dose=0.001 mg/kg
|
Starting Dose=0.003 mg/kg
n=9 Participants
Subjects with starting Dose=0.003 mg/kg
|
Starting Dose=0.01 mg/kg
n=13 Participants
Subjects with starting Dose=0.01 mg/kg
|
Starting Dose=0.03 mg/kg
n=1 Participants
Subjects with starting Dose=0.03 mg/kg
|
Starting Dose =0.1 mg/kg
n=10 Participants
Subjects with starting Dose =0.1 mg/kg
|
Total
n=40 Participants
All subjects with different starting dose combined
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Positive PAL IgE Antibody
Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Positive PAL IgE Antibody
Week 12
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: safety population
Antibody positivity over time
Outcome measures
| Measure |
Starting Dose=0.001 mg/kg
n=7 Participants
Subjects with starting Dose=0.001 mg/kg
|
Starting Dose=0.003 mg/kg
n=9 Participants
Subjects with starting Dose=0.003 mg/kg
|
Starting Dose=0.01 mg/kg
n=13 Participants
Subjects with starting Dose=0.01 mg/kg
|
Starting Dose=0.03 mg/kg
n=1 Participants
Subjects with starting Dose=0.03 mg/kg
|
Starting Dose =0.1 mg/kg
n=10 Participants
Subjects with starting Dose =0.1 mg/kg
|
Total
n=40 Participants
All subjects with different starting dose combined
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Positive Anti-PAL-PEG IgE Antibodies
Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Positive Anti-PAL-PEG IgE Antibodies
Week 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Baseline/pre-dose, Week 7, and Week 16/Day 106Population: The PK population will consist of all subjects who received any amount of study drug and have post-treatment plasma BMN 165 concentration measurements.
Plasma concentrations of rAvPAL-PEG (BMN 165)
Outcome measures
| Measure |
Starting Dose=0.001 mg/kg
n=7 Participants
Subjects with starting Dose=0.001 mg/kg
|
Starting Dose=0.003 mg/kg
n=9 Participants
Subjects with starting Dose=0.003 mg/kg
|
Starting Dose=0.01 mg/kg
n=13 Participants
Subjects with starting Dose=0.01 mg/kg
|
Starting Dose=0.03 mg/kg
n=1 Participants
Subjects with starting Dose=0.03 mg/kg
|
Starting Dose =0.1 mg/kg
n=10 Participants
Subjects with starting Dose =0.1 mg/kg
|
Total
n=40 Participants
All subjects with different starting dose combined
|
|---|---|---|---|---|---|---|
|
Trough Concentration of BMN 165
Baseline
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
|
—
|
0 ng/mL
Standard Deviation 0
|
|
Trough Concentration of BMN 165
Baseline, pre-dose
|
—
|
—
|
—
|
—
|
1.6 ng/mL
Standard Deviation 5.06
|
1.6 ng/mL
Standard Deviation 5.06
|
|
Trough Concentration of BMN 165
Week 7
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Trough Concentration of BMN 165
Week 16-Day 106
|
7.8 ng/mL
Standard Deviation 20.52
|
3.1 ng/mL
Standard Deviation 8.70
|
6.0 ng/mL
Standard Deviation 14.54
|
—
|
0 ng/mL
Standard Deviation 0
|
4.2 ng/mL
Standard Deviation 12.74
|
Adverse Events
Starting Dose=0.001 mg/kg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Starting Dose=0.003 mg/kg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Starting Dose=0.01 mg/kg
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Starting Dose=0.03 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Starting Dose=0.1 mg/kg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Starting Dose=0.001 mg/kg
n=7 participants at risk
Subjects will start on rAvPAL-PEG 0.001 mg/kg
|
Starting Dose=0.003 mg/kg
n=9 participants at risk
Subjects will start on rAvPAL-PEG 0.003 mg/kg
|
Starting Dose=0.01 mg/kg
n=13 participants at risk
Subjects will start on rAvPAL-PEG 0.01 mg/kg
|
Starting Dose=0.03 mg/kg
n=1 participants at risk
Subjects will start on rAvPAL-PEG 0.03 mg/kg
|
Starting Dose=0.1 mg/kg
n=10 participants at risk
Subjects will start on rAvPAL-PEG 0.1 mg/kg
|
|---|---|---|---|---|---|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
Other adverse events
| Measure |
Starting Dose=0.001 mg/kg
n=7 participants at risk
Subjects will start on rAvPAL-PEG 0.001 mg/kg
|
Starting Dose=0.003 mg/kg
n=9 participants at risk
Subjects will start on rAvPAL-PEG 0.003 mg/kg
|
Starting Dose=0.01 mg/kg
n=13 participants at risk
Subjects will start on rAvPAL-PEG 0.01 mg/kg
|
Starting Dose=0.03 mg/kg
n=1 participants at risk
Subjects will start on rAvPAL-PEG 0.03 mg/kg
|
Starting Dose=0.1 mg/kg
n=10 participants at risk
Subjects will start on rAvPAL-PEG 0.1 mg/kg
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 2 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Cardiac disorders
Palpitations
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Eye disorders
Eye irritation
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Eye disorders
Iritis
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Eye disorders
Vision blurred
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 3 • Screening- Week 22
|
23.1%
3/13 • Number of events 3 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • Screening- Week 22
|
22.2%
2/9 • Number of events 3 • Screening- Week 22
|
15.4%
2/13 • Number of events 2 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Gastrointestinal disorders
Nausea
|
57.1%
4/7 • Number of events 4 • Screening- Week 22
|
44.4%
4/9 • Number of events 10 • Screening- Week 22
|
30.8%
4/13 • Number of events 5 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
22.2%
2/9 • Number of events 7 • Screening- Week 22
|
15.4%
2/13 • Number of events 5 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
General disorders
Chest discomfort
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 2 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
General disorders
Chills
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
23.1%
3/13 • Number of events 4 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
General disorders
Fatigue
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
20.0%
2/10 • Number of events 2 • Screening- Week 22
|
|
General disorders
Injection site bruising
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
7.7%
1/13 • Number of events 3 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
30.0%
3/10 • Number of events 3 • Screening- Week 22
|
|
General disorders
Injection site dermatitis
|
0.00%
0/7 • Screening- Week 22
|
22.2%
2/9 • Number of events 2 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
General disorders
Injection site erythema
|
14.3%
1/7 • Number of events 3 • Screening- Week 22
|
44.4%
4/9 • Number of events 8 • Screening- Week 22
|
30.8%
4/13 • Number of events 12 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
40.0%
4/10 • Number of events 5 • Screening- Week 22
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
General disorders
Injection site nodule
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
General disorders
Injection site pain
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
22.2%
2/9 • Number of events 6 • Screening- Week 22
|
7.7%
1/13 • Number of events 2 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
General disorders
Injection site paraesthesia
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
General disorders
Injection site pruritus
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
General disorders
Injection site rash
|
28.6%
2/7 • Number of events 3 • Screening- Week 22
|
33.3%
3/9 • Number of events 5 • Screening- Week 22
|
15.4%
2/13 • Number of events 6 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
30.0%
3/10 • Number of events 3 • Screening- Week 22
|
|
General disorders
Injection site reaction
|
14.3%
1/7 • Number of events 2 • Screening- Week 22
|
66.7%
6/9 • Number of events 13 • Screening- Week 22
|
61.5%
8/13 • Number of events 32 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
50.0%
5/10 • Number of events 20 • Screening- Week 22
|
|
General disorders
Injection site swelling
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
15.4%
2/13 • Number of events 15 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
20.0%
2/10 • Number of events 3 • Screening- Week 22
|
|
General disorders
Injection site urticaria
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
General disorders
Non-cardiac chest pain
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
General disorders
Oedema peripheral
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
7.7%
1/13 • Number of events 3 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
General disorders
Pain
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 2 • Screening- Week 22
|
|
General disorders
Pyrexia
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
15.4%
2/13 • Number of events 3 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Infections and infestations
Candidiasis
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Infections and infestations
Folliculitis
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Infections and infestations
Influenza
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Infections and infestations
Injection site infection
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Infections and infestations
Nasopharyngitis
|
28.6%
2/7 • Number of events 2 • Screening- Week 22
|
22.2%
2/9 • Number of events 2 • Screening- Week 22
|
30.8%
4/13 • Number of events 4 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
100.0%
1/1 • Number of events 1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
50.0%
5/10 • Number of events 5 • Screening- Week 22
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Injury, poisoning and procedural complications
Contusion
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
15.4%
2/13 • Number of events 2 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Injury, poisoning and procedural complications
Excoriation
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
30.0%
3/10 • Number of events 3 • Screening- Week 22
|
|
Injury, poisoning and procedural complications
Laceration
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Injury, poisoning and procedural complications
Muscle strain
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Injury, poisoning and procedural complications
Thermal burn
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Investigations
Blood pressure increased
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 2 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
30.8%
4/13 • Number of events 15 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
60.0%
6/10 • Number of events 8 • Screening- Week 22
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
14.3%
1/7 • Number of events 3 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
15.4%
2/13 • Number of events 2 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
7.7%
1/13 • Number of events 2 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
15.4%
2/13 • Number of events 5 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Nervous system disorders
Dizziness
|
28.6%
2/7 • Number of events 4 • Screening- Week 22
|
22.2%
2/9 • Number of events 2 • Screening- Week 22
|
23.1%
3/13 • Number of events 5 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 2 • Screening- Week 22
|
55.6%
5/9 • Number of events 6 • Screening- Week 22
|
30.8%
4/13 • Number of events 5 • Screening- Week 22
|
100.0%
1/1 • Number of events 1 • Screening- Week 22
|
50.0%
5/10 • Number of events 9 • Screening- Week 22
|
|
Nervous system disorders
Hypoaesthesia
|
14.3%
1/7 • Number of events 2 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Nervous system disorders
Lethargy
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Nervous system disorders
Migraine
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Nervous system disorders
Paraesthesia
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
15.4%
2/13 • Number of events 2 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Nervous system disorders
Tremor
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 2 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Reproductive system and breast disorders
Vaginal exfoliation
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
22.2%
2/9 • Number of events 2 • Screening- Week 22
|
7.7%
1/13 • Number of events 2 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
20.0%
2/10 • Number of events 2 • Screening- Week 22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
22.2%
2/9 • Number of events 2 • Screening- Week 22
|
23.1%
3/13 • Number of events 3 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 2 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/7 • Screening- Week 22
|
22.2%
2/9 • Number of events 3 • Screening- Week 22
|
15.4%
2/13 • Number of events 2 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/7 • Screening- Week 22
|
22.2%
2/9 • Number of events 2 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • Screening- Week 22
|
22.2%
2/9 • Number of events 3 • Screening- Week 22
|
23.1%
3/13 • Number of events 3 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.6%
2/7 • Number of events 2 • Screening- Week 22
|
33.3%
3/9 • Number of events 5 • Screening- Week 22
|
15.4%
2/13 • Number of events 2 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
14.3%
1/7 • Number of events 1 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
30.0%
3/10 • Number of events 3 • Screening- Week 22
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
0.00%
0/13 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/7 • Screening- Week 22
|
11.1%
1/9 • Number of events 1 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
10.0%
1/10 • Number of events 1 • Screening- Week 22
|
|
Surgical and medical procedures
Myomectomy
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 1 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
|
Vascular disorders
Pallor
|
0.00%
0/7 • Screening- Week 22
|
0.00%
0/9 • Screening- Week 22
|
7.7%
1/13 • Number of events 2 • Screening- Week 22
|
0.00%
0/1 • Screening- Week 22
|
0.00%
0/10 • Screening- Week 22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60